A Phase 2b/3, Multicenter Study to Assess the Treatment Strategy of Using PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects With CCR5-tropic HIV-1 Infection
Phase: PHASE2
Conditions: HIV
Sponsor: CytoDyn, Inc.

Protocol Cover Page 
Protocol Title: A Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using 
PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in Virologically 
Suppressed Subjects with CCR5-tropic HIV-1 infection. 
Protocol Number: PRO 140_CD03  
Version: 11.0 
Document Date: 27-Nov-2019 
NCT Number: NCT02859961

CONFIDENTIAL 
Page 1 of 128 
A Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using 
PRO 140 SC as Long-Acting Single-Agent Maintenance Therapy for 48 Weeks in 
Virologically Suppressed Subjects with CCR5-tropic HIV-1 infection. 
Protocol Number: 
PRO 140_CD03 
Version: 
11.0 
Date: 
27-Nov-2019 
Sponsor: 
CytoDyn, Inc. 
1111 Main Street, Suite 660 
Vancouver, Washington 98660 
(360) 980-8524-Work
(360) 980-8549-Fax
www.cytodyn.com
Confidentiality Statement 
This document is a confidential communication of CytoDyn, Inc. It is provided for the conduct 
of a clinical research study. The information contained in this document is confidential and, except 
to the extent necessary to obtain informed consent or IEC/IRB approval, cannot be disclosed unless 
required by governmental regulation. Persons to whom any portion of the contents of this 
document is disclosed must be informed that the information is confidential and may not be further 
disclosed by them. 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
CONFIDENTIAL 
Page 2 of 128 
 
 
 
PROTOCOL APPROVAL PAGE 
 
Protocol Number: 
PRO 140_CD03 
Version: 
11.0 
Date: 
27-Nov-2019 
 
PROTOCOL APPROVAL FOR USE 
 
I have read the protocol and the appendices and agree that it contains all relevant information 
required to meet FDA, GCP and all applicable regulatory guidelines and statutes. 
Kush Dhody 
 
Electronically signed by: Kush Dhody 
Reason: I am an author of this document 
Date: 2020-01-08 15:32:34-05:00 
 
Prepared by: 
 
 
 
Kush Dhody, MBBS, MS, CCRA 
Amarex Clinical Research, LLC 
Electronically signed by: Heather Prisant 
Date 
Reviewed by: 
Heather Prisant 
Date: 2020-01-08 13:52:02-05:00 
 
08 Jan 2020 
 
 
S
Heather Prisant, MS 
Amarex Clinical Research, LLC 
Electronically signed by: Shide Badri 
ide Badri  Date: 2020-01-08 13:42:52-05:00 
Date 
08 Jan 2020 
H
Shide Badri, MD 
Amarex Clinical Research, LLC 
Electronically signed by: Hana Mekonnen 
na Mekonnen 
Date: 2020-01-14 11:04:19-05:00 
Date 
14 Jan 2020 
Hana Mekonnen, MS 
Amarex Clinical Research, LLC 
Electronically signed by: Victoria Martin 
Victoria Martin 
Date: 2020-01-08 13:43:57-05:00 
Date 
08 Jan 2020 
N
Victoria Martin, MS 
Amarex Clinical Research, LLC 
Electronically signed by: Nader Pourhassan 
der Pourhassan 
Date: 2020-01-08 10:42:09-08:00 
Date 
1/8/2020 
Approved by: 
Nader Pourhassan, PhD 
President and CEO, CytoDyn Inc. 
Date 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
CONFIDENTIAL 
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INVESTIGATOR’S SIGNATURE PAGE 
 
 
Protocol Number: 
Version: 
Date: 
PRO 140_CD03 
11.0 
27-Nov-2019 
 
 
 
 
 
 
INVESTIGATOR’S SIGNATURE 
I have read the protocol specified above and agree to participate in and comply with the procedures, 
as outlined herein for the conduct of this clinical trial. I also agree to comply with the applicable US 
Food and Drug Administration (FDA) regulations and Investigational Review Board (IRB) 
requirements for testing on human subjects. I agree to ensure that the requirements for obtaining 
informed consent are met. 
 
 
 
 
 
Principal Investigator’s Signature 
Date 
Print Name 
Address 
Site Number 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
CONFIDENTIAL 
Page 4 of 128 
 
 
 
SPONSOR INFORMATION 
 
CytoDyn, Inc. 
 
1111 Main Street, Suite 660 
Vancouver, Washington 98660 
(360) 980-8524-Work 
(360) 980-8549-Fax 
www.cytodyn.com 
 
 
 
 
CONTRACT RESEARCH ORGANIZATION INFORMATION 
 
Amarex Clinical Research, LLC (Amarex) 
 
20201 Century Boulevard, Suite 450 
Germantown, MD 20878 USA 
www.amarexcro.com 
 
Program Director: 
Kush Dhody, MBBS, MS, CCRA 
Telephone number: 
(301) 956-2536 
Fax number: 
(240) 454-7909 
E-mail: 
kushd@amarexcro.com 
 
 
Medical Monitor: 
Shide Badri, MD 
Telephone number: 
(240) 454-6825 
Fax number: 
(240) 813-2868 
E-mail: 
saereporting@amarexcro.com or 
shideb@amarexcro.com 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
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Page 5 of 128 
 
 
 
PROTOCOL SYNOPSIS 
 
Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Title of Study: 
A Multicenter Study to Assess the Clinical Safety and Treatment Strategy of Using PRO 140 SC as Long- Acting 
Single-Agent Maintenance Therapy for 48 Weeks in Virologically Suppressed Subjects with CCR5- tropic HIV-
1 infection. 
Study Center(s): Up to 60 centers in the United States 
Planned Number of Subjects: 
Approximately 500 
Study Development Phase: 
Phase-2b/3 
Indication for Use: As single-agent maintenance therapy in virally suppressed, adult subjects with CCR5- 
tropic Human Immunodeficiency Virus Type-1 (HIV-1) infection who are on antiretroviral therapy. 
Objectives: The objective is to assess the clinical safety and treatment strategy of using PRO 140 SC 350mg or 
525mg or 700mg as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5- tropic 
HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 monotherapy will be 
evaluated. 
Outcome Measures: 
Primary Safety Outcome Measures: 
The following metrics will be analyzed to assess the clinical safety of PRO 140 monotherapy regimen: 
• Incidence of Treatment-Emergent Adverse Events (TEAE) 
• Incidence of Treatment-Emergent Serious Adverse Events 
• Incidence of Injection Site Reactions by Investigator evaluation 
• Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale 
• Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants 
(using Visual Analogue Scale) 
• Changes and shifts in laboratory measurements over time 
• Changes in vital signs and weight over time 
• Changes and shift in Electrocardiogram (ECG) parameters over time 
• 
Incidence of Physical Examination abnormalities over time 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Primary Efficacy Outcome Measures: 
• Proportion of participants experiencing virologic failure at the assigned dose 
Note: (1) Virologic failure is defined as two (2) consecutive plasma HIV-1 RNA levels of ≥ 200 
copies/mL. (2) Assigned dose refers to the dose allocated at the time of randomization/enrollment. 
• Time to virologic failure at the assigned dose 
• Proportion of participants moved to rescue arm or higher dose group 
Note: Rescue is defined as subjects who were unable to maintain viral suppression, or experienced 
virologic failure, and moved to a higher dose of PRO 140 
• Proportion of participants achieving viral re-suppression (HIV-1 RNA <50 copies/mL) during Treatment 
Phase after moving to rescue arm or higher dose group 
• Time to achieving viral re-suppression (HIV-1 RNA <50 copies/mL) during Treatment Phase for 
subjects who moved to rescue arm or higher dose group 
• Proportion of participants achieving viral re-suppression (HIV-1 RNA <50 copies/mL) after experiencing 
virologic failure (during the Treatment and Follow-up Phase) 
• Time to achieving viral re-suppression (for virologic failure subjects) after re-initiation of oral 
combination antiretroviral regimen during the Follow-up Phase. 
• Proportion of participants completing 24, 48 weeks of PRO 140 treatment with HIV-1 RNA <50 
copies/mL 
• Mean change in CD4 cell count, at each visit within the Treatment Phase 
• To evaluate the prognostic factors of therapeutic success of PRO 140 monotherapy during the Treatment 
Phase. 
o 
CCR5 Receptor Occupancy 
o 
CCR5 Genotyping Status 
o 
gp120 genotyping 
o 
Baseline HIV-1 RNA Single Copy levels 
o 
Immune Activation Markers 
o 
PhenoSense® Entry Assay 
Secondary Exploratory Outcome Measures: 
• 
Measurement of treatment adherence to the PRO 140 monotherapy regimen; this will be assessed 
using number of missed PRO 140 administrations 
• 
Loss of future drug options 
The first occurrence of intermediate to high level resistance to any one or more of the standard 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
antiretroviral drugs to which the patient's virus was considered to be sensitive at trial entry (i.e. 
excluding drug resistance present at baseline). 
• 
Proportion of participants overall and within each treatment group experiencing emerging resistance 
exhibited by fold increase in maraviroc and PRO 140 FC (Fold Change in IC50 and IC90 relative to wild-
type virus) between baseline and the time of virologic failure, as a measure of post-baseline phenotypic 
resistance 
Note: Virologic failure is defined as two (2) consecutive plasma HIV-1 RNA levels of ≥ 200 copies/mL. 
Central Nervous System (CNS) sub-study: In a subset of participants (n=20): 
• 
Level of HIV-1 RNA in CSF at T1 (prior to first dose of PRO 140), T4 and VF visits 
• 
PRO 140 concentration in CSF at T1 (prior to first dose of PRO 140), T4 and VF visits 
• 
Relationship between PRO 140 concentration in plasma and CSF 
• 
Relationship between PRO 140 concentration in CSF and HIV-1 RNA in CSF 
• 
Relationship between plasma and CSF HIV-1 RNA suppression and HIV disease progression and 
safety parameters (i.e., adverse events and laboratory abnormalities) 
Genitourinary (GU) sub-study: In a subset of participants (n=20): 
• 
Level of HIV-1 RNA in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF 
visits. 
• 
PRO 140 concentration in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF 
visits. 
• 
Relationship between PRO 140 concentration in plasma and genital secretion 
• 
Relationship between PRO 140 concentration and HIV-1 RNA in genital secretion, 
• 
Relationship between plasma and genital secretion HIV-1 RNA suppression and HIV disease 
progression and safety parameters (i.e., adverse events and laboratory abnormalities) 
Safety Assessments: 
• 
Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study participants 
(using Visual Analogue Scale) and by investigator-evaluation of injection site reactions for all patients 
and within each group. 
• 
Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale 
• 
Frequency of Treatment–emergent serious adverse events 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Trial Design: 
This study is a Phase 2b/3, multi-center, randomized, two-part, open-labeled study designed to evaluate the 
efficacy, safety, and tolerability of the strategy of shifting clinically stable patients receiving suppressive 
combination antiretroviral therapy to PRO 140 monotherapy and maintaining viral suppression for 48 weeks 
following study entry. 
Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 monotherapy 
for 48 weeks during the Treatment Phase with the one week overlap of existing retroviral regimen and PRO 140 
at the beginning of the study treatment and also one week overlap at the end of the treatment in subjects who do 
not experience virologic failure. The first ~150 eligible subjects were enrolled to receive PRO 140 350mg SC 
weekly injection in a single-arm study. Subsequently, next ~150 subjects were randomized 1:1 to PRO 140 
350mg (Group A) or PRO 140 525mg (Group B). An additional ~200 subjects will be randomized 1:1 to PRO 
140 525mg (Group B) or PRO 140 700mg (Group C). 
➢ For the first ~150 enrolled subjects: 
• 
Part 1: 48-week, single-arm, open-label treatment phase 
▪ 
PRO 140 350mg SC weekly injection (Group A) 
➢ For the subsequent ~150 enrolled subjects: 
• 
Part 1: 48-week, randomized, two-arm, open-label treatment phase 
▪ 
PRO 140 350mg SC weekly injection (Group A) 
▪ 
PRO 140 525mg SC weekly injection (Group B) 
➢ For the subsequent ~200 enrolled subjects: 
• 
Part 1: 48-week, randomized, two-arm, open-label treatment phase 
▪ 
PRO 140 525mg SC weekly injection (Group B) 
▪ 
PRO 140 700mg SC weekly injection (Group C) 
As noted below, subjects in Group A or Group B that experience virologic failure prior to week 48 in Part 1 have 
option of entering Part 2 wherein they receive higher dose of PRO 140 for remainder of treatment phase or may 
re-initiate prior ART regimen (or an alternative regimen selected by their treating physician) at the discretion of 
the subject and Investigator. 
Part 2 – Rescue Arm for Group A and Group B subjects 
• 
Part 2 for Group A: single arm, open-label treatment phase for Group A subjects electing to receive 
PRO 140 525mg SC after experiencing virologic failure on 350mg SC/weekly dose 
• 
Part 2 for Group B: single arm, open-label treatment phase for Group B subjects electing to receive 
PRO 140 700mg SC after experiencing virologic failure on 525mg SC/weekly dose 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
CONFIDENTIAL 
Page 9 of 128 
 
 
Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Note: All ongoing subjects assigned to Group A receiving PRO 140 350mg SC weekly or assigned to Group B 
receiving PRO 140 525mg SC weekly have the option of participating in Part 2 should virologic failure occur. 
The study will have three phases: Screening Phase, Treatment Phase and Follow-up Phase. 
Screening Phase (up to 6 weeks): 
This phase is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study. 
This phase consists of a series of screening assessments designed to determine eligibility. A written informed 
consent from the subject will be obtained by the Investigator or suitably qualified individual before the 
performance of any protocol-specific procedure. 
Subjects will continue to take their existing antiretroviral regimen during the Screening Phase. 
Treatment Phase (48 weeks ± allowed windows): 
Treatment Phase begins with an evaluation of results of laboratory samples collected at the Screening Visit. 
Subjects who meet all eligibility criteria, as per data gathered from Screening Visit are to be treated. All subjects 
who fail to meet eligibility criteria will be considered screen failures and exit the study without further evaluation. 
The first Treatment Visit (T1) will take place within 6 weeks of the Screening Visit, with weekly visits (± 3 
days) thereafter. 
Subjects will continue their existing antiretroviral regimen for up to one week after receiving initial dosing of 
PRO 140. The study treatment (PRO 140 350mg or 525mg SC or 700mg SC injections) will be administered by 
a qualified medical professional (MD, DO, PA, LPN, LVN, NP, RN or CMA if permitted by state law) at clinic 
site or home visit or self-administered by subjects, for the duration of 48 weeks in the Treatment Phase as shown 
in Table 0-1. 
Table 0-1: Part 1: Randomized, two-arm, open-label treatment phase [PRO 140 350mg or 525mg or 700mg] 
 
 
PRO 140 
350mg 
Parenteral 
175 mg/mL 
solution 
2 injections of PRO 140 (2 X 1 mL/inj.) 
SC injection 
for 48 weeks 
 
 
PRO 140 
525mg 
Parenteral 
175 mg/mL 
solution 
2 injections of PRO 140 (2 X 1.5 mL/inj.) 
SC injection 
for 48 weeks 
 
 
PRO 140 
700mg 
Parenteral 
175 mg/mL 
solution 
2 injections of PRO 140 (2 X 2 mL/inj.) 
SC injection 
for 48 weeks 
Study Drug 
GROUP A 
Dosage 
Form 
IP 
concentration 
Dosing Frequency and Amount 
Route of 
Administration 
GROUP B 
GROUP C 

Protocol # PRO 140_CD 03 
Version 11.0 
Date: 27-Nov-2019 
CONFIDENTIAL 
Page 10 of 128 
 
 
 
Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
As shown in Table 0-2, Group A subjects that elect to participate in Part 2 of Treatment Phase after experiencing 
virologic failure (defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL) during Part 1 of Treatment 
Phase will receive PRO 140 525mg SC weekly injection for remainder of 48-week Treatment Phase. Should 
subject experience subsequent virologic failure in Part 2 of Treatment Phase, subject will complete Virologic 
Failure (VF) Visit assessments and then enter the Follow-up Phase of the study. 
Table 0-2: Part 2:Rescue Arm for Group A subjects [PRO 140 525mg] 
Study Drug 
Dosage 
 
IP 
Dosing Frequency and Amount 
 
Route of 
Form 
concentration 
 
Administration 
PRO 140 
Parenteral 
175 mg/mL 
2 injections of PRO 140 (2 X 1.5 mL/inj.) 
SC injection 
525mg 
 solution 
 
 
for remainder of treatment phase 
As shown in Table 0-3, Group B subjects that elect to participate in Part 2 of Treatment Phase after experiencing 
virologic failure during Part 1 of Treatment Phase will receive PRO 140 700mg SC weekly injection for 
remainder of 48-week Treatment Phase. Should subject experience subsequent virologic failure in Part 2 of 
Treatment Phase, subject will complete Virologic Failure (VF) Visit assessments and then enter the Follow-up 
Phase of the study. 
Table 0-3: Part 2:Rescue Arm for Group B subjects [PRO 140 700mg] 
Study Drug 
Dosage 
 
IP 
Dosing Frequency and Amount 
 
Route of 
Form 
concentration 
 
Administration 
PRO 140 
Parenteral 
175 mg/mL 
2 injections of PRO 140 (2 X 2 mL/inj.) 
SC injection 
700mg 
 solution 
 
 
for remainder of treatment phase 
Group A or Group B subjects that do not elect to participate in Part 2 of Treatment Phase and all Group C subjects 
who experience virologic failure (defined as two consecutive HIV-1 RNA levels of ≥ 200 copies/mL) at any 
time during the Treatment Phase will undergo the Virologic Failure (VF) Visit assessments and then exit the 
Treatment Phase to enter the Follow-up Phase of the study. 
Subjects who do not experience virologic failure will enter the Follow-up Phase of the study at the end of 48- 
week Treatment Phase. 
All study subjects will re-initiate their previous antiretroviral regimen or an alternative regimen selected by their 
treating physician: 
• 
One week prior to the end of 48-week Treatment Phase, or 
• 
During the Treatment Phase, if virologic failure occurs or have met any other criteria for discontinuation of 
study treatment as specified in Section 5.2.1 of the protocol. 
Efficacy assessments will include viral load measurement and CD4 cell counts at every alternate week during 
the first 16 weeks of Treatment Phase and once every four weeks during the remaining 32 weeks of Treatment 
Phase. Safety assessments will consist of determining and recording all AEs and SAEs; laboratory evaluation 
of hematology, blood chemistry, and urine analysis; periodic measurement of vital signs; and the performance 

Protocol # PRO 140_CD 03 
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Page 11 of 128 
 
 
 
Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
of physical examinations, as detailed in the schedule of procedures and assessments of the protocol. 
Follow-up Phase: 
Duration of Follow-up Phase is determined based on whether or not subject has experienced virologic failure 
during the Treatment Phase. 
• 
Group A or Group B subjects not participating in Part 2 and Group C subjects who experience virologic 
failure during the Treatment Phase will be assessed every 4 weeks until the viral suppression is achieved 
(i.e., plasma HIV-1 RNA levels decline to < 50 copies/mL). Additionally, virologic failure subjects will 
return to clinic for long-term follow-up at 6 months and at one year from the time of the Virologic Failure 
(VF) Visit. 
• 
Subjects who do not experience virologic failure and complete Treatment Visit 48 (T48), will be assessed 
every 2 weeks for total of 4 weeks. 
Duration of Treatment: 
• 
Screening Phase: up to 6 weeks 
• 
Treatment Phase: 48 weeks ± allowed windows (up to 48 treatments every week (±3 days)). 
• 
Follow-up Phase: 
o 
Virologic Failure: Until viral suppression is achieved. Additionally, subjects who experience 
virologic failure will return to clinic for long-term follow-up at 6 months and at one year from the 
time of the Virologic Failure Visit. 
o 
Non-Virologic Failure (NVF): 4 weeks 
Total Study Duration: 
58 weeks [Does not include additional long-term follow-up time for virologic failure subjects] 
Inclusion Criteria: Potential subjects are required to meet all of the following criteria for enrollment into the 
study. 
1. Males and females, age ≥18 years 
2. Receiving combination antiretroviral therapy for last 24 weeks 
3. No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in-between 
Screening Visit and First Treatment Visit. 
4. Subject has two or more potential alternative approved antiretroviral drug options to consider. 
5. Documented Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay 
6. Plasma HIV-1 RNA < 50 copies/mL at Screening Visit as determined by Human Immunodeficiency 
Virus 1 (HIV-1) Quantitative, RNA (Taqman® Real-Time PCR) 
7. No documented detectable viral loads (HIV-1 RNA > 50 copies/mL) within the last 24 weeks prior to 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Screening Visit 
A patient who has had one VL “blip” to < 200 copies/mL in the 24 weeks prior to screening may be 
included, provided that the plasma HIV-1 RNA level that immediately preceded the blip and VL test that 
immediately followed the blip was < 50 copies/mL. 
8. CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy 
9. CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit 
10. Laboratory values at Screening of: 
a. Absolute neutrophil count (ANC)  750/mm3 
b. Hemoglobin (Hb)  10.5 gm/dL (male) or  9.5 gm/dL (female) 
c. Platelets  75,000 /mm3 
d. Serum alanine transaminase (SGPT/ALT)  5 x upper limit of normal (ULN) 
e. Serum aspartate transaminase (SGOT/AST)  5 x ULN 
f. 
Bilirubin (total)  2.5 x ULN unless Gilbert's disease is present or subject is receiving atazanavir in 
the absence of other evidence of significant liver disease 
g. Creatinine  1.5 x ULN 
11. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not clinically 
significant by the Principal Investigator. 
12. Both male and female patients and their partners of childbearing potential must agree to use 2 medically 
accepted methods of contraception (e.g., barrier contraceptives [male condom, female condom, or 
diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral 
contraceptives, transdermal patches, or contraceptive rings], and intrauterine devices) during the course of 
the study (excluding women who are not of childbearing potential and men who have been sterilized). 
Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative 
urine pregnancy test prior to receiving the first dose of study drug. 
13. Willing and able to participate in all aspects of the study, including use of SC medication, completion of 
subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements 
as evidenced by providing written informed consent. 
Note: Subjects diagnosed with either substance dependence or substance abuse or any history of a 
concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in the opinion of site 
investigator these circumstances would not interfere with the subject’s successful completion of the study 
requirements. 
Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment. 
1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA Assay at the 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Screening Visit 
2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen (HBsAg) 
3. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous 
Kaposi’s sarcoma) 
4. Laboratory test values  grade 4 DAIDS laboratory abnormality. 
5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study 
6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose 
7. Any vaccination within 2 weeks prior to the first study dose. 
8. Subjects who have failed on a maraviroc containing regimen. 
9. Subjects weighing < 35kg 
10. History of anaphylaxis to any oral or parenteral drugs 
11. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin) 
Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with 
documented stable INRs can be enrolled as per discretion of the Investigator. 
12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit 
13. Any known allergy or antibodies to the study drug or excipients 
14. Treatment with any of the following: 
a. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit 
b. Immunosuppressants within 60 days prior to the screening visit 
c. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or foscarnet within 60 days 
prior to the screening visit 
d. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. Subjects on chronic 
steroid therapy  5 mg/day will be excluded with the following exception: 
o Subjects on inhaled, nasal, or topical steroids will not be excluded 
15. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study 
compliance or the ability to evaluate safety/efficacy 
Statistical Considerations: 
Sample Size Determination and Rationale: 

Protocol # PRO 140_CD 03 
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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
Approximately 500 subjects will be enrolled or randomized, in this study. A total of 100 subjects will be 
randomized to receive PRO 140 700 mg. The sample size is selected on the basis of clinical judgment. 
Analysis Populations: 
The Intent-to-Treat (ITT) population is defined as the set of subjects who were enrolled or randomized and 
have at least one dose of PRO 140. 
The Per Protocol (PP) population is defined as the set of subjects who meet the ITT population requirements, 
and were not associated with a major protocol violation. 
The Safety population is defined as all subjects who received at least one dose of PRO 140. This population 
will be used for the analysis of safety parameters. 
Interim Analysis: 
The interim analysis will be directed and conducted by an independent DMC (iDMC), which will include a 
statistician who is not otherwise involved in the trial and two clinicians. The iDMC will monitor the safety of 
the trial from the beginning and at approximately six month intervals based on enrollment thereafter. The main 
purpose of this IA is to ensure the safety of the subjects in the trial and to recommend whether the trial should 
be stopped early to protect the safety of the participants. 
The iDMC will closely monitor the following: 
• 
Virologic failure and viral re-suppression (after oral combination therapy is re-instituted). 
• 
Long-term safety follow-up data for one year after completion of treatment phase 
• 
In addition to other safety parameters, all baseline/post-treatment tropism, resistance, prognostic factors such 
as, HIV-1 RNA single copy assay, immune activation markers etc. and any potential cardiovascular events 
(that may occur from inflammatory bursts post-drug withdrawal). 
A detailed interim analysis plan will be prepared and presented to the DMC prior to the conduct of the interim 
analysis. 
Statistical Analysis: 
All data collected from the study will be presented as a by-subject listing and also summarized according to the 
variable type as: 
a. Continuous data summaries will include number of observations, mean, standard deviation, 
median, and minimum and maximum values 
b. Categorical data summaries will include frequency counts and percentages 
Primary Outcome Analysis 
The primary analysis of primary and secondary outcome measures will be conducted on the ITT population and 
PP population will be used for supportive analysis. 

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Name of Sponsor: 
CytoDyn, Inc. 
Name of Study Product: 
PRO 140 (Humanized monoclonal antibody to CCR5) 
Protocol Number: 
PRO 140 _CD03 
Indication: 
Human Immunodeficiency Virus Type-1 (HIV-1) Infection 
The primary outcome measures for this study are to assess the clinical safety of PRO 140 monotherapy regimen, 
proportion of participants experiencing virologic failure, and to evaluate the prognostic factors of therapeutic 
success of PRO 140 monotherapy during the Treatment Phase. 

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TABLE OF CONTENTS 
STUDY TITLE .............................................................................................................................. 1 
PROTOCOL SYNOPSIS.............................................................................................................. 5 
TABLE OF CONTENTS ............................................................................................................ 16 
LIST OF TABLES ............................................................................................................................. 22 
LIST OF FIGURES ............................................................................................................................ 23 
LIST OF ABBREVIATIONS ............................................................................................................... 24 
1 INTRODUCTION ................................................................................................................. 27 
1.1 
STATEMENT OF INTENT ........................................................................................................ 27 
1.2 
THE PROBLEM STATEMENT .................................................................................................. 27 
1.3 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL PRODUCT ............................................ 28 
1.4 
SUMMARY OF PRIOR PRE-CLINICAL AND CLINICAL STUDIES ............................................... 29 
1.4.1 
Pre-Clinical Studies with PRO 140 ............................................................................. 29 
1.4.2 
Clinical Studies with PRO 140 .................................................................................... 29 
1.4.2.1 
PRO 140 1101 Study ................................................................................................... 29 
1.4.2.2 
PRO 140 1102 Study ................................................................................................... 30 
1.4.2.3 
PRO 140 1103 Study ................................................................................................... 30 
1.4.2.4 
PRO 140 1302 Study ................................................................................................... 30 
1.4.2.5 
PRO 140 2301 Study ................................................................................................... 33 
1.4.2.6 
PRO 140 2101 Study ................................................................................................... 34 
1.4.2.7 
PRO 140 _CD01 Study ............................................................................................... 36 
1.4.2.8 
PRO 140 _CD01-Extension Study .............................................................................. 37 
1.4.2.9 
PRO 140 _CD02 Study ............................................................................................... 38 
1.5 
RATIONALE FOR DOSE SELECTION ....................................................................................... 41 
1.6 
RISKS / BENEFITS ASSESSMENT ............................................................................................ 42 
1.6.1 
Risks/Discomfort to Subjects and Precautions to Minimize Risk ............................... 42 
1.6.1.1 
Risks associated with using monotherapy treatment ................................................... 42 
1.6.1.2 
Allergic Reaction ......................................................................................................... 42 
1.6.1.3 
Immune Response ....................................................................................................... 43 
1.6.1.4 
Pregnancy .................................................................................................................... 43 
1.6.1.5 
Venipuncture for blood sampling and Subcutaneous injection for Study Drug 
Administration ............................................................................................................. 43 
1.6.1.6 
Risks related to resumption of viral replication in anatomically privileged 
compartments .............................................................................................................. 43 

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1.6.1.7 
Risks to the Study Personnel and the Environment ...................................................... 43 
1.6.1.8 
Unknown Risks ............................................................................................................ 44 
1.6.1.9 
Theoretical risk for increased severity of West Nile virus infection ............................ 44 
1.6.2 
Intended Benefit for Subjects ....................................................................................... 44 
2 STUDY OBJECTIVES .......................................................................................................... 45 
3 STUDY DESIGN .................................................................................................................... 47 
3.1 
STUDY CENTER(S) ................................................................................................................ 48 
3.2 
STUDY POPULATION ............................................................................................................. 48 
3.3 
ELIGIBILITY CRITERIA .......................................................................................................... 48 
3.3.1 
Inclusion Criteria .......................................................................................................... 48 
3.3.2 
Exclusion Criteria ......................................................................................................... 49 
4 STUDY SCHEDULE ............................................................................................................. 52 
4.1 
SCREENING PHASE ................................................................................................................ 63 
4.1.1 
Pre-Screening ............................................................................................................... 63 
4.1.2 
Screening Visit ............................................................................................................. 63 
4.2 
TREATMENT PHASE .............................................................................................................. 65 
4.2.1 
Treatment Phase: Treatment Visit-1 (T1) ..................................................................... 68 
4.2.2 
Treatment Phase: Treatment Visit-2 (T2) to Treatment Visit-16 (T16) ....................... 69 
4.2.3 
Treatment Phase: Treatment Visit-17 (T17) to Treatment Visit-48 (T48) ................... 71 
4.3 
VIROLOGIC FAILURE (VF) VISIT ........................................................................................... 73 
4.4 
FOLLOW-UP PHASE ............................................................................................................... 74 
4.4.1 
Follow-Up Visits .......................................................................................................... 75 
4.4.1.1 
Short-Term Follow-Up Visits ....................................................................................... 75 
4.4.1.1.1 Virologic Failure Subjects ............................................................................................ 75 
4.4.1.1.2 Non Virologic Failure Subjects .................................................................................... 75 
4.4.1.2 
Long-Term Follow-Up Visits ....................................................................................... 76 
5 SUBJECT COMPLETION AND WITHDRAWAL ........................................................... 77 
5.1 
SUBJECT COMPLETION .......................................................................................................... 77 
5.2 
SUBJECT WITHDRAWAL ........................................................................................................ 77 
5.2.1 
Discontinuation of Study Treatment ............................................................................ 78 
5.2.2 
Data Collected for Withdrawn Subjects ....................................................................... 78 
5.3 
SCREEN FAILURES ................................................................................................................ 79 
6 STUDY TREATMENT .......................................................................................................... 80 
6.1 
INVESTIGATIONAL PRODUCT DESCRIPTION ........................................................................... 80 
6.2 
INVESTIGATIONAL PRODUCT PACKAGING AND LABELING .................................................... 81 

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6.3 
INVESTIGATIONAL PRODUCT STORAGE ................................................................................. 84 
6.4 
INVESTIGATIONAL PRODUCT ADMINISTRATION .................................................................... 84 
6.5 
INVESTIGATIONAL PRODUCT RECEIPT AND ACCOUNTABILITY .............................................. 85 
6.6 
INVESTIGATIONAL PRODUCT DISPOSITION ............................................................................ 86 
7 DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES ..................... 87 
7.1 
INFORMED CONSENT ............................................................................................................. 87 
7.2 
ASSESSMENT OF ELIGIBILITY ................................................................................................ 87 
7.2.1 
Re-screening ................................................................................................................. 87 
7.3 
DEMOGRAPHIC INFORMATION ............................................................................................... 87 
7.4 
MEDICAL HISTORY ............................................................................................................... 88 
7.5 
PRIOR / CONCOMITANT MEDICATIONS AND NON-STUDY TREATMENTS ................................ 88 
7.5.1 
Excluded Medications and Therapies ........................................................................... 89 
7.5.2 
Allowable Medications and Therapies ......................................................................... 90 
7.6 
PHYSICAL EXAMINATION ...................................................................................................... 90 
7.7 
ELECTROCARDIOGRAM ......................................................................................................... 91 
7.8 
NEUROLOGICAL ASSESSMENT ............................................................................................... 91 
7.9 
VITAL SIGNS (INC. HEIGHT AND WEIGHT) .............................................................................. 91 
7.10 CLINICAL LABORATORY ASSESSMENTS ................................................................................ 91 
7.10.1 
Routine CBC ................................................................................................................ 92 
7.10.2 
Biochemistry ................................................................................................................ 92 
7.10.3 
Coagulation Indices ...................................................................................................... 92 
7.10.4 
Hepatitis B surface antigen (HBsAg) ........................................................................... 92 
7.10.5 
PK sample for PRO 140 ............................................................................................... 92 
7.10.6 
Anti-idiotypic antibodies to PRO 140 .......................................................................... 92 
7.10.7 
Serum pregnancy test .................................................................................................... 92 
7.10.8 
Urine pregnancy test ..................................................................................................... 93 
7.10.9 
Plasma HIV-1 RNA level and TruCount T Assay ........................................................ 93 
7.10.10 
HIV-1 Trofile® DNA Assay ......................................................................................... 93 
7.10.11 
HIV-1 Trofile® RNA Assay.......................................................................................... 93 
7.10.12 
HIV-1 Drug Resistance Assay ...................................................................................... 93 
7.10.13 
Serum Concentration of ART drugs ............................. Error! Bookmark not defined. 
7.10.14 
Blood sample collection for evaluation of potential biomarkers.................................. 94 
7.10.14.1 gp120 genotypes ........................................................................................................... 94 
7.10.14.2 Plasma HIV-1 RNA Single Copy Assay ...................................................................... 94 
7.10.14.3 Immune Activation Markers ........................................................................................ 94 

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7.10.14.4 PhenoSense® Entry Assay ........................................................................................... 95 
7.10.14.5 CCR5 expression levels ............................................................................................... 95 
7.10.14.6 Quest Diagnostics Tropism Assay ................................................................................ 95 
7.10.15 
Urinalysis ..................................................................................................................... 96 
7.10.16 
CSF sample collection for CNS sub-study ................................................................... 96 
7.10.17 
Genital Secretion sample collection for GU sub-study ................................................ 96 
7.11 PRO 140 ADMINISTRATION ........................................................................................................................... 96 
7.12 INJECTION SITE REACTION ASSESSMENT ............................................................................... 96 
7.13 PAIN ASSESSMENT USING VISUAL ANALOG SCALE (VAS) .................................................... 97 
7.14 MEASUREMENT OF TREATMENT ADHERENCE ....................................................................... 97 
8 STATISTICAL CONSIDERATIONS .................................................................................. 98 
8.1 
TREATMENT GROUPS ............................................................................................................ 98 
8.2 
DESCRIPTION OF STUDY OUTCOME MEASURES ..................................................................... 98 
8.2.1 
Primary Outcome Measures ......................................................................................... 98 
8.2.2 
Secondary Outcome Measures ..................................................................................... 98 
8.2.3 
Safety Assessments .................................................................................................... 100 
8.3 
SAMPLE SIZE DETERMINATION AND RATIONALE ................................................................ 100 
8.4 
RANDOMIZATION AND BLINDING ........................................................................................ 100 
8.5 
INTERIM ANALYSIS ............................................................................................................. 101 
8.6 
GENERAL STATISTICAL CONSIDERATIONS .......................................................................... 101 
8.6.1 
Analysis Populations .................................................................................................. 101 
8.6.2 
Statistical Methods ..................................................................................................... 102 
8.6.3 
Prognostic Factors/Covariates .................................................................................... 102 
8.6.4 
Handling of Missing Data .......................................................................................... 102 
8.6.5 
Multicenter Study ....................................................................................................... 102 
8.7 
DATA SUMMARY ................................................................................................................ 102 
8.7.1 
Subject Disposition ..................................................................................................... 102 
8.7.2 
Demographic and Baseline Characteristics ................................................................ 102 
8.7.3 
Prior and Concomitant Medications ........................................................................... 102 
8.7.4 
Efficacy Analysis ....................................................................................................... 103 
8.7.4.1 
Primary Analysis ........................................................................................................ 103 
8.7.4.2 
Supportive Analysis ................................................................................................... 103 
8.7.5 
Safety Analysis ........................................................................................................... 103 
8.7.5.1 
Adverse Events ........................................................................................................... 103 
8.7.5.2 
Tolerability Assessment ............................................................................................. 103 
8.7.5.3 
Clinical Laboratory Data ............................................................................................ 104 

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8.7.5.4 
Physical Examination ................................................................................................. 104 
8.7.5.5 
Vital Signs .................................................................................................................. 104 
8.7.5.6 
ECG Examination ....................................................................................................... 104 
8.7.5.7 
Neurological Assessment ........................................................................................... 104 
9 ADVERSE EVENTS (DEFINITIONS AND REPORTING) ............................................ 105 
9.1 
ADVERSE EVENT................................................................................................................. 105 
9.1.1 
Reporting of Adverse Events ..................................................................................... 105 
9.1.2 
Impact of Study Treatment ......................................................................................... 105 
9.1.3 
DAIDS AE Grade (Severity) Assessment .................................................................. 106 
9.1.4 
Causality Assessment ................................................................................................. 106 
9.1.5 
Treatment Given as a Result of the Event .................................................................. 107 
9.1.6 
Outcome Assessment ................................................................................................. 107 
9.1.7 
Expected / Anticipated Adverse Events ..................................................................... 108 
9.1.8 
SC Injection-related Events ........................................................................................ 108 
9.2 
SERIOUS ADVERSE EVENTS (SAE) ...................................................................................... 108 
9.2.1 
Reporting of Serious Adverse Events ........................................................................ 109 
9.2.2 
SAE Follow-Up .......................................................................................................... 110 
10 DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION ...................................... 111 
11 QUALITY CONTROL AND QUALITY ASSURANCE .................................................. 112 
11.1 MONITORING REQUIREMENTS ............................................................................................. 112 
11.2 ACCEPTABILITY OF CASE REPORT FORMS (CRFS) .............................................................. 112 
11.3 MODIFICATION OF PROTOCOL ............................................................................................. 112 
11.4 REPORTING PROTOCOL DEVIATIONS ................................................................................... 113 
12 DATA MONITORING COMMITTEE (DMC) ................................................................ 114 
13 ETHICS AND REGULATORY REQUIREMENTS ........................................................ 115 
13.1 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) ................ 115 
13.2 INVESTIGATOR’S RESPONSIBILITIES .................................................................................... 115 
13.3 SUBJECT INFORMED CONSENT REQUIREMENTS ................................................................... 116 
14 DATA HANDLING AND RECORD KEEPING ............................................................... 117 
14.1 RECORDING AND COLLECTION OF DATA ............................................................................. 117 
14.2 CLINICAL DATA MANAGEMENT .......................................................................................... 117 
14.3 ARCHIVING ....................................................................................................................................................... 117 
15 PUBLICATION PLAN ........................................................................................................ 119 
16 REFERENCES ..................................................................................................................... 121 

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17 APPENDIX ........................................................................................................................... 123 
17.1 APPENDIX I: AIDS-DEFINING CONDITIONS ......................................................................... 123 
17.2 APPENDIX II: DIVISION OF AIDS TABLE FOR GRADING THE SEVERITY OF ADULT AND 
PEDIATRIC ADVERSE EVENTS (DAIDS AE GRADING TABLE) ....................................................... 125 
17.3 APPENDIX III:  ADVERSE EVENTS OF SPECIAL INTEREST: INJECTION SITE REACTIONS ........ 126 
17.4 APPENDIX V: NEUROLOGICAL ASSESSMENT ....................................................................... 127 

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LIST OF TABLES 
Table 1-1: 
Clinical Studies with PRO 140 .............................................................................. 39 
Table 4-1: 
Schedule of Assessments – Screening and Treatment Phase (T1 – T16) ............... 54 
Table 4-2: 
Schedule of Assessments –Treatment Phase (T17 – T48) ..................................... 58 
Table 4-3: 
Schedule of Assessments –Follow-Up (FU) Phase ................................................ 61 
Table 4-4: 
Part 1: Randomized, Two-Arm, Open-Label Treatment Phase ............................ 66 
Table 4-5: 
Part 2: Single-Arm, Open-label Treatment Phase [Group A] ................................ 66 
Table 4-6: 
Part 2: Single-Arm, Open-label Treatment Phase [Group B] ................................ 66 
Table 6-1: 
Investigational Product - PRO 140 ........................................................................ 81 
Table 9-1: 
DAIDS AE Grading General Guidelines ............................................................. 106 

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LIST OF FIGURES 
Figure 1-1: 
PRO 140 1302 Study: Mean of the maximum (nadir) log10 reductions in HIV RNA 
. .............................................................................................................................. 31 
Figure 1-2: 
PRO 140 1302 Study: Mean log10 reductions in HIV RNA over time .................. 31 
Figure 1-3: 
PRO 140 1302 Study: PRO 140 serum concentrations following a single 
intravenous injection in HIV- infected individuals ............................................... 32 
Figure 1-4: 
PRO 140 2301 Study: Mean change from baseline in HIV-1 RNA (Log10 
copies/mL) over Time (ITT Subjects) ................................................................... 33 
Figure 1-5: 
PRO 140 2101 Study: Mean of the maximum (nadir) log10 reductions in HIV RNA 
. .............................................................................................................................. 34 
Figure 1-6: 
PRO 140 2101 Study: Mean change from baseline in HIV-1 RNA (Log10 
copies/mL) over Time (ITT Subjects) ................................................................... 35 
Figure 1-7: 
Change in CD4+ cell counts in subjects treated with subcutaneous PRO 140. ..... 35 
Figure 1-8: 
Emax analysis of antiviral data generated with IV and SC PRO 140. ................... 41 
Figure 3-1: 
Study Flow Diagram .............................................................................................. 51 
Figure 6-1: 
PRO 140 (CHO) 175mg/mL - Vial Label .............................................................. 82 
Figure 6-2: 
PRO 140 (CHO) 175mg/mL - Syringe Label ........................................................ 82 
Figure 6-3: 
PRO 140 (CHO) 175mg/mL - Kit Label ............................................................... 83 
Figure 7-1: 
Visual Analog Scale ............................................................................................... 97 

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LIST OF ABBREVIATIONS 
 
Abbreviation 
Term 
AE 
AIDS 
Adverse Event 
Acquired Immune Deficiency Syndrome 
ALT 
ANC 
ART 
AST 
Alanine Transaminase 
Absolute Neutrophil Count 
Anti Retroviral Therapy 
Aspartate Transaminase 
ATC 
AUC 
C 
cART 
CBC 
Anatomic Therapeutic Classification 
Area Under Curve 
Celsius 
Combination Antiretroviral Therapy 
Complete Blood Count 
CCR5 
CDC 
CFR 
CHO 
C-C chemokine receptor type 5 
Centers for Disease Control and Prevention 
Code of Federal Regulations 
Chinese Hamster Ovary 
cm 
CRF 
Cmax 
CRO 
Centimeter 
Case Report Form 
Maximal Concentration 
Contract Research Organization 
CS 
DAIDS 
DMC 
DNA 
Clinically Significant 
Division of AIDS 
Data Monitoring Committee 
Deoxyribonucleic Acid 
DO 
ECG 
eCRF 
Doctor of Osteopathic Medicine 
Electrocardiogram 
Electronic Case Report Form 
Emax 
et al 
F 
FDA 
FDP 
Maximum drug effect 
et aliae; Latin for "and others" 
Fahrenheit 
U.S. Food and Drug Administration 
Fixed Dose Procedure 
FU 
GCP 
Follow-Up 
Good Clinical Practice 
HAART 
Highly Active Antiretroviral Therapy 
Hb 
Hemoglobin 

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Abbreviation 
Term 
HBsAg 
HCT 
Hepatitis B Surface Antigen 
Hematocrit 
HEENT 
Head, Ears, Eyes, Nose, and Throat 
HIPAA 
Health Insurance Portability Accountability Act 
HIV 
Human Immunodeficiency Virus 
IA 
IB 
ICF 
Interim Analysis 
Investigator’s Brochure 
Informed Consent Form 
ICH 
i.e. 
IEC 
IND 
International Conference on Harmonization 
id est; Latin for “that is” 
Independent Ethics Committee 
Investigational New Drug 
INR 
IP 
IRB 
ISR 
International Normalized Ratio 
Investigational Product 
Institutional Review Board 
Injection Site Reactions 
ITT 
IV 
LAR 
LDH 
Intent-to-treat 
Intravenous 
Legally Acceptable Representative 
Lactate dehydrogenase 
LPN 
LVN 
mAb 
MD 
Licensed Practical Nurse 
Licensed Vocational Nurse 
Monoclonal Antibody 
Doctor of Medicine 
MedDRA 
mg 
mL 
mm 
Medical Dictionary for Regulatory Activities 
Milligram 
Milliliter 
Millimeter 
MW 
NCS 
NP 
NTF 
Molecular Weight 
Not Clinically Significant 
Nurse Practitioner 
Non-Treatment Failure 
OBT 
PA 
Optimized Background Therapy 
Physician Assistant 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
PP 
Per Protocol 

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Abbreviation 
Term 
PT 
Prothrombin Time 
QC 
Quality Control 
RBC 
Red Blood Cells 
RN 
Registered Nurse 
RNA 
SAE 
Ribonucleic acid 
Serious Adverse Event 
SAP 
SC 
SD 
SOP 
SV 
Statistical Analysis Plan 
Subcutaneous 
Standard Deviation 
Standard Operating Procedure 
Screening Visit 
TEAE 
TF 
Treatment Emergent Adverse Events 
Treatment Failure 
USA 
United States of America 
VAS 
Visual Analogue Scale 
WBC 
White Blood Cells 

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1 
INTRODUCTION 
 
1.1 
STATEMENT OF INTENT 
The design, conduct and reporting of this trial shall be conducted in compliance with the protocol, 
International Conference on Harmonization/Good Clinical Practice (ICH/GCP), and all 
appropriate regulatory requirements. Investigator(s) participating in this study will have 
documented training in GCP. Independent monitoring of the trial will be accomplished utilizing 
Amarex Clinical Research as the Contract Research Organization (CRO). 
 
1.2 
THE PROBLEM STATEMENT 
Substantial progress has been made over the past two decades in the development of effective and 
well tolerated combination antiretroviral regimens. Most HIV-1 infected persons who initiate 
antiretroviral therapy at early stages in the disease process and who are fully adherent to their 
antiretroviral regimens can anticipate life expectancies that are measured in decades. Although 
these advances have revolutionized antiretroviral therapy for most HIV-1 infected patients, 
contemporary lifelong daily adherence to treatment regimens remains challenging for a significant 
subset of patients. A number of studies have been conducted to evaluate the possibility of treatment 
simplification following control of viral replication with an induction regimen (Arribas JR, 2005) 
(Pulido F, 2008) (Moltó J, 2007) (Cameron DW, 2008) (Nunes EP, 2009) (Meynard JL, 2010) 
(Katlama C, 2010) (Gutmann C, 2010) (Cahn P, 2011) (Guiguet M & CO4., 2012). Most of these 
simplification trials have involved the substitution of a boosted HIV- 
1 protease inhibitor such as lopinavir or darunavir for an effective combination regimen. Although 
the strategy has been successful in a substantial fraction of those who undergo regimen 
simplification, the overall body of evidence suggests that boosted protease inhibitor maintenance 
therapy is generally less effective than maintenance on a three drug regimen (Calza L, 2012) 
(Thompson MA, 2012). Factors influencing the likelihood of success include the duration of 
successful suppression prior to the regimen simplification and the extent to which patients are 
adherent to their simplified regimens (Calza L, 2012). Although it has also been suggested that 
some patients may fail because of variability in trough concentrations of protease inhibitors, this 
has not been substantiated in rigorously conducted studies (Boffito M, 2003). Other concerns that 
have been raised include the ability of HIV-1 protease inhibitors to achieve suppressive levels in 
the central nervous system (Thompson MA, 2012). The current consensus appears to be that this 
approach should be reserved for specific patient populations in which considerations related to 
chronic nucleoside toxicity and/or adherence to complex antiretroviral regimens are dominant. In 
these situations, the importance of adherence and of close monitoring of plasma HIV-1 RNA levels 
has been emphasized. In the case of HIV-1 protease inhibitor maintenance therapy, reestablishment 
of control of retroviral replication has generally been achieved by resumption of combination 
therapy. 

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Also, there is an interest in the development of infrequently administered therapy both as a 
treatment and a prevention strategy. The Long-Acting Antiretroviral Treatment Enabling (LATTE) 
study tested a combination of two oral antiretroviral drugs, the non-nucleoside reverse 
transcriptase inhibitor rilpivirine and the new integrase inhibitor GSK1265744 (Spreen WR, 2013). 
Furthermore, a long-acting injectable medication can be an effective approach to circumvent the 
need for daily medication adherence and/or chronic nucleoside toxicity. 
Although PRO 140 would require either subcutaneous (SC) or intravenous (IV) administration, its 
favorable pharmacokinetics might allow dosing as infrequent as once weekly or bi-weekly. The 
ability to administer the drug infrequently under medical supervision could obviate one of the 
continuing challenges of close adherence to daily boosted protease inhibitor regimens that appear 
to be relatively unforgiving in maintenance settings when administered as the sole antiretroviral 
regimen. This is an open-label study of PRO 140 monotherapy as maintenance therapy for subjects 
previously fully suppressed on combination antiretroviral regimen. PRO 140 is a promising new 
antiretroviral agent that does not show any cross-resistance with drugs from other classes. The 
purpose of this study is to assess the clinical safety and treatment strategy of using PRO 140 SC 
as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-
1 infection. 
 
1.3 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL PRODUCT 
PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 
5 (CCR5), under development as a therapy for human immunodeficiency virus (HIV) infection. 
PRO 140 binds to the N terminus (Nt) and the extracellular loop 2 (ECL2) domain of the CCR5 
cell surface receptor that HIV-1 uses to gain entry to a cell. PRO 140 binding to CCR5 blocks the 
final phase of viral binding to the cell surface prior to fusion of the viral and cell membranes. PRO 
140 has been administered intravenously or subcutaneously to 174 HIV-1 infected individuals in 
Phase I/II studies of safety, tolerability, pharmacokinetics and pharmacodynamics (Jacobson JM 
T. M., 2010) (Jacobson JM L. J., 2010). The drug has been well tolerated following administration 
of single doses of 0.5 to 5 mg/kg or up to three weekly doses of up to 324 mg. Single subcutaneous 
doses of 324 mg have resulted in drops in plasma HIV-1 RNA levels of approximately 1.0 log10. 
Repetitive weekly administration of this dose of PRO 140 has been associated with drops in plasma 
HIV-1 RNA levels of approximately 1.5 log10. Serum concentrations of PRO 140 above the IC50 
for clinical isolates of HIV-1 are maintained for at least 2 weeks following a single dose of 324 
mg. Plasma HIV-1 RNA levels rise to baseline levels as PRO 140 is cleared from the plasma and, 
presumably, other compartments. 

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1.4 
SUMMARY OF PRIOR PRE-CLINICAL AND CLINICAL STUDIES 
1.4.1 Pre-Clinical Studies with PRO 140 
In vitro and in vivo preclinical studies have been conducted to determine the pharmacokinetic, 
immunogenicity, and toxicity profiles of PRO 140 following IV and SC administration. Several 
acute and chronic toxicity studies have been conducted to support the clinical development plan. 
Acute toxicity of PRO 140 was evaluated in New Zealand rabbits, following IV administration of 
5 or 15 mg/kg. Chronic toxicity was evaluated in cynomolgus monkeys following biweekly 
administration of IV doses up to 10 mg/kg for six months and biweekly administration of various 
SC doses up to 50 mg/kg for 24 weeks. The drug was generally well tolerated. Biweekly 
administration of IV doses up to 10 mg/kg for six months resulted in minimum to mild lymphoid 
hyperplasia in assorted lymph nodes and spleen, which was considered an expected immune 
response to a foreign protein. Biweekly administration of SC doses up to 50 mg/kg for 24 weeks 
resulted in minimum injection-site reactions (minimal, multifocal, mononuclear cell infiltrates in 
the subcutis), which were considered due to an inflammatory response to the injected antigen. 
Monkeys tolerated treatment with PRO 140 for 24 weeks without evidence of local or systemic 
toxicity. PRO 140 caused no mortality, cageside observations, in-life injection-site observations, 
or gross pathologic findings. Chronic treatment with PRO 140 did not affect body weight, food 
consumption, hematology, clinical chemistry or coagulation parameters. 
Both IV and SC administration resulted in elimination half-lives of approximately 200 hours, and 
overall exposure increased with increasing doses. Following SC administration of PRO 140 in 
monkeys, the maximal concentration (Cmax) was achieved within 56 hours and bioavailability for 
PRO 140 after SC dosing was approximately 70%. 
1.4.2 Clinical Studies with PRO 140 
Current human experience with PRO 140 consists of seven completed and two ongoing clinical 
trials. These studies are summarized in Table 1-1. In all the completed clinical trials, the majority 
of adverse events (AEs) were mild or moderate. No dose-limiting toxicities or patterns of drug-
related toxicities were observed. Antiviral activity was potent, rapid, prolonged, dose- dependent, 
and highly significant. 
1.4.2.1 PRO 140 1101 Study 
For the first-in-human trial, PRO 140 1101, the drug was administered IV at 0.1, 0.5, 2.0, or 5.0 
mg/kg and was generally well tolerated, non-immunogenic, and without clinically relevant 
toxicity. Treatment Emergent Adverse Events (TEAEs) did not increase with rising PRO 140 dose 
levels. 75% of subjects reported TEAEs, most of which were deemed unrelated to study treatment. 

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1.4.2.2 PRO 140 1102 Study 
In PRO 140 1102 study, the majority of AEs, other than injection-site reactions, were considered 
mild and possibly related to drug administration. The majority of injection-site reactions were 
considered mild, self-resolving, and definitely related to drug administration. PRO 140 derived 
from Chinese Hamster Ovary (CHO) cells and administered SC at 100 mg/mL was generally well 
tolerated in healthy, normal volunteers. Overall, PRO 140 administered SC using Autoject® 2 
appeared better tolerated than manual injection. 
1.4.2.3 PRO 140 1103 Study 
In PRO 140 1103 study, administration of PRO 140 at 350 mg using Autoject® 2 appeared well 
tolerated. Manual injections, on the other hand, were associated with a greater number of AEs. 
There did not appear, however, to be any substantial difference in subject perception of pain or 
discomfort related to site of drug administration. No anti-PRO 140 antibodies were detected in any 
subjects in this study. There was a tendency of higher exposure associated with SC administration 
of PRO 140 at 350 mg in the abdomen and the thigh. A higher number of AEs was associated with 
injections in the arm. Based on these observations, thigh and abdominal administration of PRO 
140 were preferred over arm injection. 
1.4.2.4 PRO 140 1302 Study 
This initial proof-of-concept study was a randomized, double-blind, placebo-controlled study in 
subjects with early-stage, asymptomatic HIV infection, only R5 HIV-1 detectable, and no 
antiretroviral therapy for 12 weeks. Subjects (n=39) were randomized to receive a single IV 
injection of placebo or PRO 140 at doses of 0.5, 2, or 5 mg/kg. Subjects were monitored for 
antiviral effects, safety and PRO 140 pharmacokinetics (PK) for 58 days. 
The study enrolled 31 males and 8 females. The median age, CD4+ cell count and HIV-1 RNA at 
baseline were 40.3 years, 484cells/μL and 26,900 copies/mL, respectively. The baseline 
characteristics were similar for all treatment groups. 
PRO 140 demonstrated potent, rapid, prolonged and dose-dependent antiviral activity (Figure 
1-1 and Figure 1-2). A single 5mg/kg dose reduced viral loads by 1.83 log10 on average (Figure 1-
2). These reductions represent the largest antiviral effects reported after just one dose of any HIV-
1 drug (Jacobson JM S. M., 2008). In the 5 mg/kg group, mean viral load reductions of greater 
than 1 log10 were sustained for 2-3 weeks post-treatment (Figure 1-2). 

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Figure 1-1: 
PRO 140 1302 Study: Mean of the maximum (nadir) log10 reductions in HIV 
RNA 
 
 
 
2 
 
 
1.5  
 
 
1 
 
 
0.5 
 
 
0 
 
Figure 1-2:  PRO 140 1302 Study: Mean log10 reductions in HIV RNA over time 
 
There was no change in R5 virus susceptibility to PRO 140 following treatment. All subjects had 
R5-only virus at screening in the first-generation Trofile assay. R5-only tropism results were 
observed in all subjects at all other timepoints, with two exceptions: One of nine (11%) of 
placebo 
0.5 mg/kg 
2 mg/kg 
5 mg/kg 
1.83 
1.2 
0.58 
0.39 
Mean Maximum Log 10 
Reduction in HIV RNA 

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placebo subjects had dual/mixed virus at baseline and all subsequent timepoints, reflecting a 
spontaneous and stable switch in co-receptor tropism results. One of 30 (3%, 0.5 mg/kg group) 
had a dual/mixed tropism result on day 8 and R5-only results at all other timepoints, including the 
end of the day (Jacobson JM S. M., 2008). Clonal analysis of the dual/mixed virus revealed that it 
reflected outgrowth of pre-existing undetected virus rather than mutation of an R5 virus to a 
dual/mixed virus following treatment (Marozsan, 2008). Therefore, no significant development of 
viral resistance to PRO 140 was observed despite potent and prolonged (2-3 weeks on average) 
viral suppression, followed by slow washout of the drug. Given that resistance to other classes of 
HIV-1 drugs can develop within one week of monotherapy (Demeter LM, 2000) (Saag, 1993) 
(Richman, 1994), the findings indicate that PRO 140 presents a high barrier to viral resistance in 
vivo. 
Figure 1-3 illustrates the mean serum concentrations of PRO 140 after IV injection. Serum levels 
increased with increasing dose. The mean Area Under Curve (AUC) from time zero to infinity 
(AUC∞) values were 11.1, 74.3 and 278 mg x day/L for the 0.5, 2 and 5 mg/kg groups. The mean 
serum half-life was 3.5-3.9 days in the two highest dose groups. In addition, PRO 140 significantly 
masked CCR5 on circulating lymphocytes for 2-4 weeks (Jacobson JM S. M., 2008). The PK and 
receptor occupancy data were broadly consistent with the duration of antiviral effects. 
Figure 1-3: PRO 140 1302 Study: PRO 140 serum concentrations following a single 
intravenous injection in HIV- infected individuals. 
 
0.5 mg/kg 
2 mg/kg 
5 mg/kg 
300.0 
 
100.0 
 
 
10.00 
 
 
1.00 
 
 
0.10 
 
0.03 
0 
5 
10 
15 
20 
25 
30 
Study Day 
 
The figure illustrates the mean serum concentrations over time by treatment group. The error bars 
depict standard deviations. The mean serum half-lives were 3.9 days and 3.5 days in the 2 mg/kg 
and 5 mg/kg dose groups, respectively. 
PRO 140 Serum Concentration, g/mL 

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Intravenous PRO 140 was generally well tolerated. No drug-related serious events or dose- limiting 
toxicity was observed. The most common adverse events (headache, lymphadenopathy, diarrhea, 
and fatigue) were observed at similar frequencies across the placebo and PRO 140 dose groups. 
There was no significant effect on QTc interval intervals or other electrocardiographic parameters, 
and there were no remarkably laboratory findings. There was no loss or depletion of CD4+ or 
CCR5+ cells from the circulation. At the 5 mg/kg dose, there was a trend towards increased CD4+ 
cell counts from baseline, with mean changes of +129, +96 and +83 cells/μL observed on days 8, 
15, and 22, respectively. 
1.4.2.5 PRO 140 2301 Study 
PRO 140 2301 was a multi-center, randomized, double-blind, placebo-controlled, parallel group 
study in 30 male and female adult subjects infected with HIV-1. Subjects were randomized to one 
of three groups (N=10/group), each receiving one of three treatments: (i) a single IV dose of 5 
mg/kg by 30-minute IV infusion; (ii) a single IV dose of 10 mg/kg by 30-minute IV infusion; 
(iii) a single placebo dose by 30-minute IV infusion. The objective of the study was to assess and 
characterize the PK and PD of PRO 140 administered by IV infusion, assess efficacy at a new 
dosage level, and safety and tolerability of single doses of PRO 140. 
All PRO 140-treated subjects had more than 10-fold reduction in viral loads (mean max log10 
reductions were 1.83 for treatment groups and 0.32 for placebo) (Figure 1-4). Both the 5 mg/kg 
and 10 mg/kg doses have shown favorable tolerability and no dose-limiting toxicity has been 
observed. High levels of receptor occupancy (> 85% reduction in the number of cells detected) 
were observed for 29 days after treatment with both 5 and 10 mg/kg doses. 
Figure 1-4:  PRO 140 2301 Study: Mean change from baseline in HIV-1 RNA (Log10 
copies/mL) over Time (ITT Subjects) 
 

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1.4.2.6 PRO 140 2101 Study 
A subcutaneous (SC) form of PRO 140 was tested in HIV-infected subjects. The trial was a 
randomized, double-blind, placebo-controlled study in subjects (n=44) with early-stage, 
asymptomatic HIV infection, only R5 HIV-1 detectable, and no antiretroviral therapy for 12 weeks 
(Thompson, 2009). Placebo (n=10) and three PRO 140 doses were examined: 162mg weekly for 
three weeks (n=11), 324mg weekly for three weeks (n=11), and 324mg biweekly (every other 
week) for two doses (n=12). Subjects were followed for 44 days after the final dose. The study 
enrolled 40 males and 4 females. The median age, weight, CD4+ cell count and HIV-1 RNA at 
baseline were 42.3 years, 79.1 kg, 410 cells/μL and 20,000 copies/mL, respectively. Baseline 
characteristics were similar for the different treatment groups. 
Potent, dose-dependent and highly statistically significant antiviral activity was observed (Figure 
1-5 and Figure 1-6). The 324mg weekly dose resulted in a mean 1.65 log10 reduction in viral load, 
and highly significant reductions were observed for the other dose groups as well (Figure 1-5). 
There was no viral rebound between 324mg doses, and the antiviral effects persisted for one week 
after the final dose Figure 1-6. The trial established the first antiviral proof of concept for a long-
acting, self-administrable drug for HIV-1 infection (Thompson, 2009). 
 
Figure 1-5:  PRO 140 2101 Study: Mean of the maximum (nadir) log10 reductions in HIV 
RNA 
 
placebo 
162mg Days 1,8,15 
324mg Days 1, 15 
2 
 
 
1.5 
 
 
1 
 
 
0.5 
 
 
0 
 
1.65 
 
1.37 
0.58 
0.23 
Mean Maximum Log10 Reduction in HIV RNA 

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Figure 1-6: 
PRO 140 2101 Study: Mean change from baseline in HIV-1 RNA (Log10 
copies/mL) over Time (ITT Subjects) 
 
0.5 
 
 
0.0 
 
 
-0.5 
 
 
-1.0 
 
 
-1.5  
 
1 
8 
15 
22 
29 
36 
43 
50 
57 
64 
Study Day 
 
 
Treatment 
 
 
Subcutaneous PRO 140 was generally well tolerated both locally and systemically. There was no 
obvious dose-related pattern of toxicity. The most common adverse events (diarrhea, headache, 
lymphadenopathy and hypertension) were mild to moderate and self-resolving. These events are 
common in HIV infection and were reported with similar frequencies in the placebo and PRO 140 
treatment groups. Administration-site reactions were mild, transient, and observed in a fraction of 
subjects. There was a trend towards increased CD4+ cell counts in subjects treated with PRO 140 
(Figure 1-7). Based on its encouraging antiviral and tolerability profiles and the convenience of 
weekly self-administration, SC PRO 140 has been selected for further clinical development. 
Figure 1-7:  Change in CD4+ cell counts in subjects treated with subcutaneous PRO 140. 
Subjects (n=10 to 12 per group) were randomized to received placebo weekly (Days 1, 8, 15), 
162mg PRO 140 weekly (Days 1, 8, 15), 324mg PRO 140 biweekly (Days 1, 15, with placebo on 
Day 8), or 324mg PRO 140 weekly (Days 1, 8, 15). CD4+ cell counts were measured over time, 
and the median change from baseline was determined for each treatment group. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Mean Log10 Change in HIV-1 RNA 

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125 
100 
75 
50 
25 
0 
-25 
-50 
1 8 15 22 29 36 43 50 57 64 
125 
100 
75 
50 
25 
0 
-25 
-50 
1 8 15 22 29 36 43 50 57 64 
 
 
125 
100 
75 
50 
25 
0 
-25 
-50 
1 8 15 22 29 36 43 50 57 64 
Study Day 
125 
100 
75 
50 
25 
0 
-25 
-50 
1 8 15 22 29 36 43 50 57 64 
Study Day 
 
 
 
 
1.4.2.7 PRO 140 _CD01 Study 
PRO 140_CD01 study (open-label, 43 subjects, multi-center) (12-cohort 1, 28-cohort 2, 3-cohort 3) 
evaluated the efficacy, safety, and tolerability of PRO 140 monotherapy (350 mg subcutaneous 
injection weekly for up to 12 weeks) for the maintenance of viral suppression following 
substitution of antiretroviral therapy in HIV-1 infected patients (with exclusive CCR5- tropic 
virus). Participants in this study were experienced HIV-infected individuals who were 
virologically suppressed on combination antiretroviral therapy. Consenting patients were shifted 
from combination antiretroviral regimen to PRO 140 monotherapy for 12 weeks. 
Forty (43) subjects (M/F: 40/3) with median age of 55 years (26-72) and median CD4 T-cell count 
of 604.5 cells/mm3 (365-1240) were enrolled in the CD01 study. Overall, twenty-three out of 43 
(54%) enrolled subjects completed 12 weeks of PRO140 monotherapy without experiencing 
virologic failure. Virologic failure was defined as two consecutive HIV-1 RNA levels of ≥ 400 
copies/mL separated by at least 3 days. 
 
 
 
 
 
 
 
 
 
 
 
Median Change in CD4+ Cells 
Median Change in CD4+ Cells 

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Of the first 40 enrolled subjects enrolled under cohort 1 and cohort 2, three subjects were found to 

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have Dual/Mixed (D/M) tropism [1 at baseline and 2 at the time of virologic failure] and 37 
subjects were found to have exclusive CCR5-tropic virus. A letter of amendment was filed to 
increase the planned number of subjects from 40 to 43 subjects to compensate for the 3 Dual/Mixed 
subjects enrolled in the study. 
All virologic failure subjects who had available lab data in both studies achieved viral suppression 
to < 400 HIV-1 RNA copies/mL, as well as viral suppression to ‘Non Detectable’ or 
< 50 HIV-1 RNA copies/mL after re-initiation of ART. 
The by-subject analysis of PhenoSense® Entry Assay data for PRO140, maraviroc, and AMD3100 
shows no significant changes in the post-treatment IC50 and IC90 values were noted when compared 
with baseline values in virologic failure and non-virologic failure groups of subjects. 
Anti-PRO140 antibodies were not identified in any post-treatment sample and data derived from 
the CD01 study further supports the favorable PRO140 PK profile data generated from both pre- 
clinical as well as prior Phase 1/2 clinical trials. 
Safety data were analyzed for all 43 enrolled subjects. One (1) of 43 subjects experienced an SAE 
that was deemed not related to the study drug by the Principal Investigator. Twenty-nine 
(29) of 43 subjects (67%) experienced one or more adverse events (AEs) after receiving at least 
one dose of PRO140. The most commonly occurring AEs were infections and infestation 
conditions which were reported by 14 of 43 (32.5%) subjects. The majority of the reported AEs 
(62/87; 71.2%) were deemed either unlikely or not related to study treatment by the Investigator. 
Similarly, the majority of the reported AEs (70/87; 80.4%) were deemed mild in nature. 
1.4.2.8 PRO 140 _CD01-Extension Study 
PRO 140_CD01-Extension study (open-label, 17 subjects, multi-center) seeks to evaluate the 
efficacy, safety, and tolerability of PRO 140 monotherapy (350 mg subcutaneous injection weekly 
for up to 160 weeks) for the continued maintenance of viral suppression following substitution of 
antiretroviral therapy in HIV patients (with exclusive CCR5-tropic virus). Participants in this study 
were HIV-infected individuals who were virologically suppressed on combination antiretroviral 
therapy and completed the first 12 weeks of CD01 study without experiencing virologic failure. 
As with the CD01 study, virologic failure was defined as two consecutive HIV-1 RNA levels of ≥ 
400 copies/mL separated by at least 3 days. Consenting patients may remain on PRO 140 
monotherapy for up to 160 weeks. 
A total of 17 subjects participated in the CD01-Extension study of which one subject was 
considered not eligible as subject experienced virologic failure prior to first extension treatment. 
Sixteen (16) eligible subjects (M/F: 14/2) with median age of 54.9 years (26-68) and median 
CD4 T-cell count of 593 cells/mm3 (365-1059) were enrolled in an extension study. One patient 
discontinued at week 37 (with viral load of <40 copies/mL) due to relocation. Two subjects were 

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withdrawn due to non-treatment related SAEs at week 140 and 149, respectively. One subject 
was withdrawn due to re-starting their ART at week 99. Two subjects withdrew consent at week 
81 and 139, respectively. Five (5) subjects experienced virologic failure (VF) (two consecutive 
viral load of ≥400 copies/mL). The mean time to virologic failure was 329 days (106-691). 
Five (5) subjects are currently receiving weekly 350 mg PRO140 SC monotherapy and have 
completed more than three years of treatment (176 - 198 weeks). Overall, 12 subjects completed 
at least one year of treatment and 9 subjects completed at least two years of treatment in this 
study 
PRO140 was generally well tolerated, and no drug-related SAEs were observed. 
This clinical study is currently ongoing. 
1.4.2.9 PRO 140 _CD02 Study 
PRO 140_CD02 study (double blind, placebo controlled, 30 subjects, multi-center) seeks to 
evaluate the efficacy, safety, and tolerability of PRO 140 in combination with existing ART 
(failing regimen) for one week and Optimized Background Therapy (OBT) for 24 weeks in patients 
infected with HIV-1. The study population includes 30 treatment-experienced HIV- infected adult 
patients with CCR5-tropic virus who demonstrates evidence of HIV-1 replication despite ongoing 
antiretroviral therapy with documented history of genotypic or phenotypic resistance to at least 
one ART drug within three drug classes (or within two or more drug classes with limited treatment 
options). The options may be limited as a result of drug antiviral class cross-resistance or 
documented treatment intolerance. 
In double-blind treatment period, virally non-suppressed subjects will be randomized and treated 
with either PRO 140 or Placebo in combination with the failing ART regimen for 7 days. The 
primary efficacy endpoint is proportion of participants with ≥ 0.5 log10 reduction in HIV-1 RNA 
viral load from baseline at the end of the 7 day functional monotherapy period. 
During the 24-week open-label period, all subjects will receive PRO 140 along with Optimized 
Background Therapy (OBT). 
This clinical study is completed. 

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Table 1-1: 
Clinical Studies with PRO 140 
 
Protocol Number 
Phase 
No. of 
Subjects 
(Planned/ 
Analyzed) 
Doses 
Cell line used 
to make PRO- 
140 
Subject 
Population 
Comments 
PRO 140 1101 
1 
20/20 
Single 0.1, 0.5, 2.0, or 5.0 mg/kg 
Sp2/0 
myeloma 
Healthy 
Generally well tolerated; non-immunogenic; dose- 
dependent coating of CCR5; significant coating of 
CCR5 over placebo at 0.5, 2, and 5 mg/kg 
PRO 140 1102 
1 
20/20 
Either two or three doses totaling 
200 or 350 mg respectively 
CHO 
Healthy 
Generally well tolerated; drug derived from CHO 
cells well tolerated also; SC administration by 
Autoject® 2 better tolerated than manual injection 
PRO 140 1103 
1 
15/14 
Two doses, each of 350 mg 
CHO 
Healthy 
More AEs associated with arm injection; trend of 
lower exposure in arm injections; thigh and 
abdominal administration preferred 
PRO 140 1302 
1b 
40/39 
Single 0.5, 2.0, or 5.0 mg/kg 
Sp2/0 
myeloma 
HIV-1 
positive 
Generally well tolerated; antiviral suppression 
maintained for approx. 10 days with higher doses; 
favorable tolerability and potent, dose-dependent 
antiviral activity provide proof-of-concept 
PRO 140 2301 
2a 
30/31 
Single 5.0 or 10.0 mg/kg 
CHO 
HIV-1 
positive 
Generally well tolerated with no dose-limiting 
toxicities; potent antiviral suppression maintained for 
approx. 20 days when administered IV at 5 or 10 
mg/kg. No dose-limiting toxicities at 10 mg/kg. 
PRO 140 2101 
2a 
40/44 
Three doses of 162 or 324 mg 
each 
CHO 
HIV-1 
positive 
Generally well tolerated, no drug-related SAEs or 
dose-limiting toxicity; antiviral activity was 
statistically significant; two-fold exposure at higher 
dose; single dose demonstrated favorable tolerability, 
and potent, long-acting, dose-dependent antiviral 
activity. 
PRO 140 _CD01 
2b 
43/43 
350 mg SC weekly dose for 12 
weeks of Monotherapy (total 
treatment duration 14 weeks) 
CHO 
HIV-1 
positive 
Generally well tolerated, no drug-related SAEs, 
weekly dose demonstrated favorable tolerability, and 
potent, long-acting, dose-dependent antiviral 
activity. 
 
 
 

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PRO 140 _CD01- 
Extension 
2b 
17/17 
350 mg SC weekly dose for 160 
weeks of Monotherapy (total 
treatment duration 161 weeks) 
CHO 
HIV-1 
positive 
This clinical study is currently ongoing 
PRO 140 
_CD02 
2b/3 
50/52 
Placebo or 350mg SC for 1 dose, 
followed by 350mg SC weekly 
dose for 24 weeks (total treatment 
duration 25 weeks) 
CHO 
HIV-1 
positive 
This clinical study is completed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.5 
RATIONALE FOR DOSE SELECTION 
The dose of 350 mg administered SC was chosen in light of a previous analysis suggesting that 
such a dose would be likely to provide maximal viral load suppression. 
In studies with antiviral agents that block viral entry through the CCR5 receptor, there is a general 
consensus that in order to achieve robust antiviral effects and minimize the potential for drug 
resistance in combination therapy, the dose of drug should result in exposures that fall on the 
plateau of a Maximum Drug Effect (Emax) plot. 
Figure 1-8:  Emax analysis of antiviral data generated with IV and SC PRO 140. 
 
The maximal viral load reduction was analyzed with regard to drug exposure for PRO 140. Figure 
1-8 above shows this relationship. Analysis shows that PR0 140 350mg weekly dose is expected 
to fall on the plateau of the Emax plot. 
The maximal change in HIV-1 viral load from baseline was determined at any point 59 days after 
initiation of therapy. To allow approximate comparisons between the IV and SC doses, the overall 
AUC observed for repeat SC doses was conservatively estimated by multiplying the measured 
AUC0-7d by the number of doses administered. Viral load and AUC data were fit to an Emax 
equation: E = Emax x AUC/(AUC + AUC50). The orange diamond indicates projected data for 
three weekly 350 mg doses based on the mean exposure observed in the PRO 140 1103 study. 
 
 
 
 
 

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It is important to note that when larger proteins (MW > 10,000) are administered SC, they initially 
traffic through the lymphatic system. Uptake into the bloodstream occurs after the proteins reach 
the thoracic duct (Nishikawa M, 2005). In addition, based on pharmacodynamic data from our 
prior SC and IV studies, maximum virologic suppression is expected to be achieved with trough 
concentrations that equal or exceed approximately 5 µg/mL. 
Finally, the mean nadir reduction in viral load achieved with 3 weekly 324 mg SC doses (1.65 
log10) was similar to the mean nadir reductions observed with single 5 or 10 mg/kg IV doses (1.8 
log10 in each case), and higher viral load reductions are expected in the present study based on the 
use of the 350 mg CHO formulation. Overall, several lines of evidence indicate that maximum 
virologic suppression will be achieved with 350 mg weekly dosing in the present study. 
Majority of subjects receiving 350 mg weekly SC dosing in monotherapy setting experienced 
virologic failure in CD01-Extension study. Review of PRO 140 clinical data to date with 350mg 
SC weekly dosing, suggests no evidence of emergence of viral isolates with reduced susceptibility 
to PRO 140, no altered viral tropism or anti-PRO 140 antibodies formation suggesting the most 
likely cause of viral rebound is inadequate dosing to fully cover CCR5 receptor populations. Based 
on pharmacologic modeling studies, we anticipate that the 525mg and 700mg dose will result in a 
lower fraction of study participants with trough levels below that which will ‘uncoat’ a significant 
number of CD4 cells (i.e., less than a certain multiple of the IC50 or IC90 for PRO 140). 
 
1.6 
RISKS / BENEFITS ASSESSMENT 
1.6.1 Risks/Discomfort to Subjects and Precautions to Minimize Risk 
1.6.1.1 Risks associated with using monotherapy treatment 
Study treatment (PRO 140 350mg or 525mg or 700mg SC injection) may not be effective in 
achieving a reduction in viral load for all subjects. Such cases could lead to an increased risk of 
developing drug resistance, opportunistic infections and clinical progression of the disease. As 
patients will not be receiving concomitant antiretroviral drugs of other antiviral classes, should 
PRO 140 therapy fail, selection of viral variants with reduced susceptibility to these agents would 
be unlikely (and was not observed in the PRO 140_CD 01 or PRO 140_CD 01-Extension studies). 
1.6.1.2 Allergic Reaction 
PRO 140 belongs to the monoclonal antibody class of drugs. Monoclonal antibodies are sometimes 
associated with allergic reactions (fatigue, diarrhea, fever, vomiting, headache, nausea, pain at 
the site of injection, low blood pressure, rash, itching, and chills) or flu-like 

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reactions such as fever, chills, and aches. These events are usually of short duration if they occur 
at all. Severe allergic reactions, however, can be life-threatening. Although anaphylaxis has not 
been observed in prior trials of PRO 140, infusion of proteins always carries with it the theoretical 
risk for anaphylactic shock. Accordingly, whenever PRO 140 is initially administered to subjects, 
there should be available and in place the procedures required to manage anaphylactic shock. 
1.6.1.3 Immune Response 
Subjects who take PRO 140 or other monoclonal antibodies can also develop an immune response 
to PRO 140 that may affect their ability to receive monoclonal antibodies, or to benefit from 
diagnosis or therapy with a monoclonal antibody in the future. 
1.6.1.4 Pregnancy 
Risks to unborn babies are unknown at this time; pregnant females will be excluded from this 
study. Females of childbearing potential must have a negative pregnancy test prior to enrollment. 
Both male and female patients and their partners of childbearing potential must agree to use 
appropriate birth control methods throughout the study duration (excluding women who are not of 
childbearing potential and men who have been sterilized). 
1.6.1.5 Venipuncture for blood sampling and Subcutaneous injection for Study Drug 
Administration 
Venipuncture for blood sample collection and subcutaneous injection for study drug administration 
carries a minimal risk of minor discomfort and the possibility of minor bruising at the site of the 
needle puncture and, rarely, the possibility of infection at the needle puncture site. 
1.6.1.6 Risks related to resumption of viral replication in anatomically privileged 
compartments 
It is possible that penetration of PRO 140 into certain key anatomic compartments such as the 
central nervous system (CNS) or the male genital tract will be insufficient to control viral 
replication in those locations. Loss of control of viral replication in the CNS could result in the 
development or exacerbation of HIV-1 Associated Neurocognitive Disorders (HAND) and that a 
lack of control of HIV-1 replication in the male genital tract could be associated with an increased 
risk of HIV-1 transmission following unprotected sexual encounters. 
1.6.1.7 Risks to the Study Personnel and the Environment 
The principal risk in the clinical setting is in the handling of needles that may be contaminated 
with HIV, or other human pathogens. Adherence to universal precautions for working with 
infectious agents will reduce the risk of exposure to these individuals. All bio-hazardous waste 

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will be disposed of as stipulated by local, state, and federal regulations and in accordance with 
study site Standard Operating Procedures (SOPs). 
1.6.1.8 Unknown Risks 
As with all research there is the remote possibility of risks that are unknown or that cannot be 
foreseen based on current information. 
1.6.1.9 Theoretical risk for increased severity of West Nile virus infection 
Individuals who lack a functional CCR5 gene are at increased risk for severe infection by West 
Nile virus (Thompson, 2009) Because of this, treatment with CCR5 co-receptor antagonists poses 
a theoretical risk for increased severity of West Nile virus infection. However, this concern is 
mitigated by several factors. First, no increased risk was observed for individuals who possess one 
functional and one non-functional CCR5 gene, indicating that an intermediate amount of CCR5 is 
sufficient for defense against West Nile virus (Thompson, 2009). Second, use of CCR5 co-receptor 
antagonists is unlikely to completely abrogate CCR5 function, and there has been no association 
reported to date between CCR5 co-receptor use and severe West Nile virus. Additionally, PRO 
140 weakly antagonizes the natural activity of CCR5 and thus is less likely to adversely affect 
immune function. Furthermore, this has not been established to be a risk with maraviroc, the anti-
CCR5 drug already FDA-approved for the treatment of HIV. 
Collectively, the experience with both IV and SC, simulation modeling and the recent confirmation 
that a higher concentration of PRO 140 synthesized using a highly efficient CHO cell line can be 
conveniently and safely administered has resulted in the design of the current study. 
1.6.2 Intended Benefit for Subjects 
This study provides an opportunity for subjects to receive once weekly SC treatment with PRO 
140. Subjects participating in the present monotherapy study for 48 weeks will contribute to the 
development of a drug which has the potential to become a treatment option for them and others 
in the future. 

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2 
STUDY OBJECTIVES 
The objective of this study is to assess the clinical safety and treatment strategy of using PRO 140 
SC as long-acting, single-agent maintenance therapy for the chronic suppression of CCR5- tropic 
HIV-1 infection. In addition, the prognostic factors of therapeutic success of PRO 140 
monotherapy will be evaluated. 
The primary outcome measures will be to assess the clinical safety of PRO 140 monotherapy 
regimen, proportion of participants experiencing virologic failure for all subjects and within each 
treatment group, and to evaluate the prognostic factors of therapeutic success of PRO 140 
monotherapy during the Treatment Phase. In addition, time to virologic failure for all subjects and 
within each treatment group, proportion of participants achieving viral re-suppression (HIV- 1 
RNA < 50 copies/mL) after experiencing virologic failure for all subjects and within each 
treatment group, time to achieving viral re-suppression (HIV-1 RNA < 50 copies/mL) after 
experiencing virologic failure for all subjects and within each treatment group, proportion of 
virologic failure subjects achieving viral re-suppression with re-initiation of previous baseline 
antiretroviral regimen for all subjects and within each treatment group, proportion of participants 
with viral suppression (HIV-1 RNA < 50 copies/mL) at week 48 for all subjects and within each 
treatment group, and mean change in CD4 cell count, at each visit within the Treatment Phase for 
all subjects and within each treatment group. 
The secondary outcome measures will be measurement of treatment adherence to the PRO 140 
monotherapy regimen, loss of future drug options [The first occurrence of intermediate to high 
level resistance to any one or more of the standard antiretroviral drugs to which the patient's virus 
was considered to be sensitive at trial entry (i.e. excluding drug resistance present at baseline)] and 
proportion of participants overall and within each treatment group experiencing emerging 
resistance exhibited by fold increase in maraviroc and PRO 140 FC (Fold Change in IC50 and IC90 
relative to wild-type virus) between baseline and the time of virologic failure, as a measure of post-
baseline phenotypic resistance. 
Note: Virologic failure is defined as two (2) consecutive plasma HIV-1 RNA levels of ≥ 200 
copies/mL. 
In a subset of participants (n=20) from Central Nervous System (CNS) study: Level of HIV-1 
RNA in CSF at T1 (prior to first dose of PRO 140), T4 and VF visits, PRO 140 concentration in 
CSF at T1 (prior to first dose of PRO 140), T4 and VF visits, relationship between PRO 140 
concentration in plasma and CSF, relationship between PRO 140 concentration in CSF and HIV- 
1 RNA in CSF, and relationship between plasma and CSF HIV-1 RNA suppression and HIV 
disease progression and safety parameters (i.e., adverse events and laboratory abnormalities) will 
be evaluated. 
 
 
 
 

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In a subset of participants (n=20) from Genitourinary (GU) sub-study: Level of HIV-1 RNA in 
genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF visits, PRO 140 
concentration in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 and VF visits, 
relationship between PRO 140 concentration in plasma and genital secretion, relationship between 
PRO 140 concentration and HIV-1 RNA in genital secretion, and relationship between plasma and 
genital secretion HIV-1 RNA suppression and HIV disease progression and safety parameters (i.e., 
adverse events and laboratory abnormalities) will be evaluated. 
Safety assessments include evaluation of tolerability of repeated subcutaneous administration of 
PRO 140 as assessed by study participants (using Visual Analogue Scale) and by investigator – 
evaluation of injection site reactions for all subjects and within each treatment group, frequency of 
Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale and frequency of 
treatment-emergent serious adverse events. 

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3 
STUDY DESIGN 
This study is a Phase 2b/3, multi-center, randomized, two-part, open-label study designed to 
evaluate the efficacy, safety, and tolerability of the strategy of shifting clinically stable patients 
receiving suppressive combination antiretroviral therapy to PRO 140 monotherapy and 
maintaining viral suppression for 48 weeks following study entry. 
Consenting patients will be shifted from combination antiretroviral regimen to weekly PRO 140 
monotherapy for 48 weeks during Part 1 of Treatment Phase with the one week overlap of existing 
retroviral regimen and PRO 140 at the beginning of the study treatment and also one week overlap 
at the end of the treatment in subjects who do not experience virologic failure. The first ~150 
eligible subjects were enrolled to receive PRO 140 350mg SC weekly injection in a single-arm 
study. Subsequently, next ~150 subjects were randomized 1:1 to PRO 140 350mg (Group A) or 
PRO 140 525mg (Group B). An additional ~200 subjects will be randomized 1:1 to PRO 140 
525mg (Group B) or PRO 140 700mg (Group C). 
As shown, subjects in Group A or Group B that experience virologic failure prior to week 48 in 
Part 1 have option of entering Part 2 wherein they receive higher dose of PRO 140 for remainder 
of treatment phase or may re-initiate prior ART regimen (or an alternative regimen selected by 
their treating physician) at the discretion of the subject and Investigator. 
➢ For the first ~150 enrolled subjects: 
• Part 1: 48-week, single-arm, open-label treatment phase 
▪ 
PRO 140 350mg SC weekly injection (Group A) 
➢ For the subsequent ~150 enrolled subjects: 
• Part 1: 48-week, randomized, two-arm, open-label treatment phase 
▪ PRO 140 350mg SC weekly injection (Group A) 
▪ PRO 140 525mg SC weekly injection (Group B) 
➢ For the subsequent ~200 enrolled subjects: 
• Part 1: 48-week, randomized, two-arm, open-label treatment phase 
▪ PRO 140 525mg SC weekly injection (Group B) 
▪ PRO 140 700mg SC weekly injection (Group C) 
Part 2 – Rescue Arm for Group A and Group B subjects 
• Part 2 for Group A: single arm, open-label treatment phase for Group A subjects electing 
to receive PRO 140 525mg SC after experiencing virologic failure on 350mg SC/weekly 
dose 
• Part 2 for Group B: single arm, open-label treatment phase for Group B subjects electing 
to receive PRO 140 700mg SC after experiencing virologic failure on 525mg SC/weekly 
dose 

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Note: All ongoing subjects assigned to Group A receiving PRO 140 350mg SC weekly or assigned 
to Group B receiving PRO 140 525mg SC weekly have the option of participating in Part 2 should 
virologic failure occur. 
The study is divided into three phases: Screening, Treatment and Follow-up. 
 
3.1 
STUDY CENTER(S) 
Approximately up to 60 centers in the United States will enroll patients in this study. 
 
3.2 
STUDY POPULATION 
Study population consists of virally suppressed HIV-1 patients with CCR5-tropic virus who are 
on antiretroviral therapy. 
 
3.3 
ELIGIBILITY CRITERIA 
3.3.1 Inclusion Criteria 
Subjects must meet all of the following criteria to be included in the study: 
1. Males and females, age ≥18 years 
2. Receiving combination antiretroviral therapy for last 24 weeks 
3. No change in antiretroviral regimen within last 4 weeks prior to Screening Visit and in- 
between Screening Visit and First Treatment Visit 
4. Subject has 2 or more potential alternative approved antiretroviral drug options to consider 
5. Documented Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile® DNA 
Assay 
6. Plasma HIV-1 RNA < 50 copies/mL at Screening Visit as determined by Human Immuno- 
deficiency Virus 1 (HIV-1) Quantitative, RNA ( Taqman® Real-Time PCR) 
7. No documented detectable viral loads (HIV-1 RNA > 50 copies/mL) within the last 24 weeks 
prior to Screening Visit 
A patient who has had one VL “blip” to < 200 copies/mL in the 24 weeks prior to screening 
may be included, provided that the plasma HIV-1 RNA level that immediately preceded the 
blip and VL test that immediately followed the blip was < 50 copies/mL. 
8. CD4 cell count of > 200 cells/mm3 since initiation of anti-retroviral therapy 
9. CD4 cell count of > 350 cells/mm3 in preceding 24 weeks and at Screening Visit 
10. Laboratory values at Screening of: 
a. Absolute neutrophil count (ANC)  750/mm3 
b. Hemoglobin (Hb)  10.5 gm/dL (male) or  9.5 gm/dL (female) 

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c. Platelets  75,000 /mm3 
d. Serum alanine transaminase (SGPT/ALT)  5 x upper limit of normal (ULN) 
e. Serum aspartate transaminase (SGOT/AST)  5 x ULN 
f. Bilirubin (total)  2.5 x ULN unless Gilbert's disease is present or subject is receiving 
atazanavir in the absence of other evidence of significant liver disease 
g. Creatinine  1.5 x ULN 
11. Clinically normal resting 12-lead ECG at Screening Visit or, if abnormal, considered not 
clinically significant by the Principal Investigator 
12. Both male and female patients and their partners of childbearing potential must agree to use 2 
medically accepted methods of contraception (e.g., barrier contraceptives [male condom, 
female condom, or diaphragm with a spermicidal gel], hormonal contraceptives [implants, 
injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], and 
intrauterine devices) during the course of the study (excluding women who are not of 
childbearing potential and men who have been sterilized). Females of childbearing potential 
must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test 
prior to receiving the first dose of study drug 
13. Willing and able to participate in all aspects of the study, including use of SC medication, 
completion of subjective evaluations, attendance at scheduled clinic visits, and compliance 
with all protocol requirements as evidenced by providing written informed consent. 
Note: Subjects diagnosed with either substance dependence or substance abuse or any history 
of a concomitant condition (e.g., medical, psychologic, or psychiatric) may be enrolled if in 
the opinion of site investigator these circumstances would not interfere with the subject’s 
successful completion of the study requirements. 
3.3.2 Exclusion Criteria 
Potential subjects meeting any of the following criteria will be excluded from enrollment: 
1. CXCR4-tropic virus or Dual/Mixed tropic (R5X4) virus as determined by Trofile® DNA 
Assay at Screening Visit 
2. Hepatitis B infection as manifested by the presence of Hepatitis B surface antigen 
(HBsAg) 
3. Any active infection or malignancy requiring acute therapy (with the exception of local 
cutaneous Kaposi’s sarcoma) 
4. Laboratory test values of ≥ grade 4 DAIDS laboratory abnormality 
5. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant 
during the study 

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6. Unexplained fever or clinically significant illness within 1 week prior to the first study dose 
7. Any vaccination within 2 weeks prior to the first study dose. 
8. Subjects who have failed on a maraviroc containing regimen. 
9. Subjects weighing < 35kg 
10. History of anaphylaxis to any oral or parenteral drugs 
11. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin) 
Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant 
therapy dose with documented stable INRs can be enrolled as per discretion of the 
Investigator. 
12. Participation in an experimental drug trial(s) within 30 days of the Screening Visit 
13. Any known allergy or antibodies to the study drug or excipients 
14. Treatment with any of the following: 
a. Radiation or cytotoxic chemotherapy with 30 days prior to the screening visit 
b. Immunosuppressants within 60 days prior to the screening visit 
c. Immunomodulating agents (e.g., interleukins, interferons), hydroxyurea, or 
foscarnet within 60 days prior to the screening visit 
d. Oral or parenteral corticosteroids within 30 days prior to the Screening Visit. 
Subjects on chronic steroid therapy  5 mg/day will be excluded with the following 
exception: 
o Subjects on inhaled, nasal, or topical steroids will not be excluded 
15. Any other clinical condition that, in the Investigator's judgment, would potentially 
compromise study compliance or the ability to evaluate safety/efficacy 

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Figure 3-1: 
Study Flow Diagram 
 
 
Informed 
Consent 
 
Screening Visit 
(SV) 
Does 
Subject Meet 
Inclusion/Exclusion 
Criteria? 
 
No 
Screen 
Failure 
Yes 
 
 
T1 
Pre-enrollment Eligibility 
Is Subject 
No 
Still Eligible? 
 
Screen 
Failure 
 
Yes 
 
Randomization 
 
 
 
 
No 
 
 
Did Subject 
have Virologic 
Failure? 
 
 
 
Yes 
 
Virologic Failure (VF) Visit 
 
 
Subject will be followed up 
every 4 Weeks till viral 
suppression is achieved 
 
T48 Visit 
7(± 3) days from last visit 
 
 
 
 
Short-term follow-up 
visits to continue every 
four weeks till the viral 
suppression is achieved 
VF – FU1 
4 Weeks (± 7 Days) after VF Visit 
 
 
 
 
NVF –FU1 
2 Weeks (± 3 Days) after T48 Visit 
 
 
NVF –FU2 
4 Weeks (± 3 Days) after T48 Visit 
 
 
 
 
End of Study 
 
VF – FU2 
8 Weeks (± 7 Days) after VF Visit 
VF – 6mFU 
6 Months (± 1 Month) after VF Visit 
VF – FU3 
12 Weeks (± 7 Days) after VF Visit 
Weekly visits between T1 and T48, 
occuring 7(± 3) days from last visit 
TREATMENT PHASE 
T1 to T48 Visits 
SCREENING 
PHASE 
FOLLOW UP PHASE 
4 Weeks (NVF Subjects) or 
12 Months (VF Subjects) 
48 Weeks 
6 Weeks 
Continue 
Treatment 
T1 (First Treatment Administration): 
within 6 Weeks of Screening Visit 
VF – 12mFU 
12 Months (± 1 Month) after VF Visit 

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4 
STUDY SCHEDULE 
The study is divided into three phases: Screening, Treatment and Follow-up. 
(1) Screening Phase (Screening to T1 Visit) begins with signing of Informed Consent and lasts 
up to 6 weeks. Subject will enter the Treatment Phase as soon as HIV-1 viral tropism results 
are available for review by Investigator. 
Treatment Phase (T1 to T48 Visit) begins with Treatment Phase begins with an evaluation of 
results of laboratory samples collected at the Screening Visit. The first treatment (T1) visit will 
be administered within 42 days of the Screening Visit, with weekly visits (± 3 days) thereafter. 
The first 300 eligible subjects were randomized 1:1 to receive either PRO 140 350mg weekly 
(Group A) or PRO 140 525mg weekly (Group B). Once the enrollment of 300 subjects was 
completed, additional subjects will be randomized 1:1 to PRO 140 525mg (Group B) or PRO 
140 700mg (Group C). 
All subjects will continue taking their existing ART during the Screening Phase and for first 
week of the Treatment Phase. After Week 1 of the Treatment Phase, subjects will stop their 
existing ART regimen and receive assigned dose of PRO 140 SC monotherapy. 
Study participants will be regularly monitored for viral load following initiation of PRO 140, 
and will cease weekly study treatment injections should they experience virologic failure. 
Subjects who experience virologic failure at any point during Part 1 of Treatment Phase will 
undergo the Virologic Failure (VF) Visit assessments and then exit the Treatment Phase to 
enter the Follow-up Phase of the study. unless subjects in Group A opt to enter Part 2 of 
Treatment Phase and receive PRO 140 525mg SC weekly injections or subjects in Group B opt 
to enter Part 2 of Treatment Phase and receive PRO 140 700mg SC weekly injections for 
remainder of 48-week Treatment Phase. 
Subjects who do not experience virologic failure will enter the Follow-up Phase of the study at 
the end of 48-week Treatment Phase. 
(2) Follow-Up Phase: The duration of follow-up depends on the status of viral load suppression. 
 
• Subjects who experience virologic failure will be followed up every 4 weeks until viral 
suppression is achieved (i.e., plasma HIV-1 RNA levels to return to < 50 copies/mL). 
Additionally, virologic failure subjects will return to clinic at 6 months and at one year 
from the time of the Virologic Failure (VF) Visit. 
• Subjects who do not experience virologic failure at the end of 48-week Treatment Phase, 
will be followed up every 2 week for total of 4 weeks. 

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Procedures to be performed during each of these study phases are described below and provided 
as a Schedule of Assessments in Table 4-1, Table 4-2 and Table 4-3. 

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Table 4-1: 
Schedule of Assessments – Screening and Treatment Phase (T1 – T16) 
 
Procedure/Assessments 
Treatment Phase (T1 – T16) 
In case of 
Treatment 
Failure 
Visit 
SV 
T1 
T2 
T3 
T4 
T5 
T6 
T7 
T8 
T9 
T10 
T11 
T12 
T13 
T14 
T15 
T16 
VF 
(Pre-Rx) 
(Post-Rx) 
Window Period 
Within 6 weeks of SV 
±3 days since last treatment 
Informed Consent[1] 
X 
Eligibility Evaluation[2] 
X 
Pre-enrollment Eligibility 
X 
Subject Demographics 
X 
Medical History[3] 
X 
X 
Physical Examination 
X 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X[4] 
X 
Neurological Assessment[5] 
X 
X 
X 
Vital Signs[6] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Body Weight & Height 
X 
ECG 
X 
X 
Complete Blood Count (CBC)[7] 
X 
X 
X 
Biochemistry[8] 
X 
X 
X 
Coagulation Indices 
X 
X 
X 
Serum Pregnancy Test[9] 
X 
Urinalysis[10] 
X 
X 
X 
Urine Pregnancy Test[9] 
X 
HBsAg 
X 
Plasma HIV-1 RNA level 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TruCount T assay[11] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Trofile® DNA Assay 
X 
X 
X[28] 
Trofile® RNA Assay 
X[28] 
HIV-1 Drug Resistance Assay [12] 
X 
X 
X 
Serum concentration of ART 
drugs[13] 
X 
X 
X 
X 
Randomization (via CTMS)[29] 
PRO 140 Administration[30] 
− 
Group A (350mg SC) 
− 
Group B (525mg SC) 
− 
Group C (700mg SC) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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Procedure/Assessments 
Treatment Phase (T1 – T16) 
In case of 
Treatment 
Failure 
Visit 
SV 
T1 
T2 
T3 
T4 
T5 
T6 
T7 
T8 
T9 
T10 
T11 
T12 
T13 
T14 
T15 
T16 
VF 
(Pre-Rx) 
(Post-Rx) 
Window Period 
Within 6 weeks of SV 
±3 days since last treatment 
Combination ART Regimen [14] 
X 
X 
X 
Injection Site Reaction Assessment 
[15] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Injection Site Pain Assessment 
(VAS)[16] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PK sample for PRO 140[17] 
X 
X 
X 
X 
X 
X 
Anti-idiotypic antibodies to PRO 
140[17] 
X 
X 
X 
X 
X 
X 
Measurement of treatment 
adherence[18] 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Potential Biomarkers 
gp120 genotypes[19] 
X 
HIV-1 RNA Single Copy Assay[20] 
X 
X 
X 
Immune Activation Markers[21] 
X 
X 
PhenoSense® Entry Assay[22] 
X 
X 
X 
CCR5 expression levels[23] 
X 
Quest Diagnostics Tropism 
Assay[24] 
X 
X[25] 
X 
CNS sub-study (n=20) 
CSF sample collection[26] 
X 
X 
X 
GU sub-study (n=20) 
Genital Secretion sample collection[27] 
X 
X 
X 
X 
CCR5 Receptor Occupancy[31] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CCR5 Genotyping[32] 
X 
X 
X 
Foot Notes: 
[1] 
Informed consent must be obtained prior to patient participation in any protocol-related activities that are not part of routine care. 
[2] 
Initial evaluation of patient eligibility will be performed by Investigator. 
[3] 
Medical history, past surgeries, disease history, history of substance abuse, social history, blood transfusion history, and current therapies (medications and non- 
medications). 
[4] 
Symptom-directed physical examination at clinic visits. 

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[5] 
The neurological assessment tool is based on the three question survey used by Simioni et al. (Simioni S, 2010). Additional neurological assessment modalities may 
be used as per Investigator’s discretion. 
[6] 
Vital signs (blood pressure, heart rate, respiration rate, and temperature) will be measured at clinic visit. Note: Only post-treatment vitals will be measured beyond 
T2. 
[7] 
Hemoglobin, Hematocrit (HCT), Red Blood Cells (RBC), White Blood Cells (WBC) with total and differential count, Absolute Neutrophil Count (ANC) and platelets. 
[8] 
Serum Biochemistry 
Hepatic function indicators: total and direct bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, Lactate 
dehydrogenase (LDH) 
Renal function indicators: BUN, creatinine 
Electrolytes: sodium, potassium, chloride, calcium and bicarbonate 
Other: glucose (random), cholesterol (total) 
[9] 
ONLY performed on women of childbearing potential. 
[10] Urine samples will be tested for color, appearance, specific gravity, pH, protein, glucose, occult blood, ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, and 
microscopic examination of urine sediment. 
[11] Includes: Absolute Lymphocytes, CD3 cell count, CD4 cell count, CD8 cell count, CD3%, CD4% and CD8%Monogram Biosciences GenoSure Archive Assay will 
be performed at Screening and prior to PRO 140 administration at T1 visit. 
[12] Monogram Biosciences GenoSure Archive Assay performed at SV and T1; PhenoSense® GT (and PhenoSense Integrase and GeneSeq Integrase testing, if 
applicable), will be performed at the time of virologic failure. 
[13] To assess subject compliance in abstaining from previous ART regimen after T2 visit 
[14] Study subjects a will continue to take their existing antiretroviral regimen up to one week after receiving initial dosing of PRO 140. Subjects will re-initiate their previous 
antiretroviral regimen or an alternative regimen selected by their treating physician if virologic failure occurs or have met any other criteria for discontinuation of study 
treatment as specified in Section 5.2.1 of the protocol. 
[15] Injection Site Reaction Assessment as assessed by Investigator (or designee) at the clinic visits and by visiting nurse or qualified medical professional during home 
visits. Injection Site Reaction Assessment will not be applicable if PRO 140 is self-administered by subjects at home. 
[16] Subject-perceived injection site pain will be assessed using the Pain Visual Analog Scale (VAS) prior to study treatment administration which evaluates average pain 
since last treatment. Injection Site Pain Assessment will not be applicable if PRO 140 is self-administered by subjects at home. 
[17] Blood sample collected at T1 ( prior to first dose of PRO 140), T4, T8, T12, T16 and VF visits 
[18] Treatment adherence self-reported by subject at T4, T8, T12, T16 and VF visits when subject comes to clinic. 
[19] Blood sample will be collected at T1 visit to assess the baseline gp120 genotypes from each enrolled subject to identify potential polymorphisms that may decrease 
PRO 140 susceptibility and may affect response to PRO 140 
[20] Blood sample collected at T1 (prior to first dose of PRO 140), T8 and T12 visits. Blood sample will be collected at T8 and T12 visit only if last known viral load result is 
“Target Not Detected “ or < 40 copies/mL. 
[21] immune activation markers (CRP, IL-6, D-Dimer) 
[22] Monogram Biosciences HIV-1 PhenoSense® Entry assay with AMD3100 (X4 inhibitor drug), Maraviroc and PRO 140 (R5 inhibitor drugs). Sample collected for 
Trofile DNA/RNA at Screening will be used to test PhenoSense® Entry for eligible/enrolled subjects at Baseline. 
[23] Flow cytometry and the 2D7 MAb will be used to measure CCR5 expression levels on peripheral blood mononuclear cells (PBMCs) 
[24] Quest Diagnostics HIV-1 Coreceptor Tropism with Reflex to Ultradeep Sequencing or HIV-1 Proviral Tropism. 
[25] If assessment not performed at SV. 
[26] To evaluate PRO 140 concentration and HIV-1 RNA level in cerebrospinal fluid (CSF) 
[27] To evaluate PRO 140 concentration and HIV-1 RNA level in genital secretions 

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[28] Monogram Biosciences Trofile® DNA or RNA assay (or both) will be performed at the Virologic Failure Visit depending on the last known HIV-1 RNA levels. 
[29] Randomization will occur via CTMS 
[30] Should VF occur, Group A or Group B subjects may transition to high dose IP and continue in 48-week treatment phase. 
[31] To assess the number CCR5 receptors on patients’ CD4 cell surface, and number and percentage of CCR5 receptors that are covered by PRO 140. Sites should not 
collect samples on Fridays, since InCellDx lab cannot receive samples on Saturdays. 
[32] No new sample collection needed. The residual whole blood sample collected for tropism assessment at Screening or at post-treatment visits will be used for testing of 
CCR5 genotyping (homozygous or heterozygous status). 

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Table 4-2: 
Schedule of Assessments –Treatment Phase (T17 – T48) 
 
Procedure/Assessments 
Treatment Phase (T17 – T48) 
In case of 
Treatment 
Failure 
Visit 
T17 
T18-21 
T22-25 
T26-29 
T30-33 
T34-37 
T38-41 
T42-45 
T46 
T47 
T48 
VF 
Window Period 
±3 days since last treatment 
Physical Examination 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X[1] 
X 
X 
Neurological Assessment[2] 
X 
X 
Vital Signs[3] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECG 
X 
X 
Complete Blood Count (CBC)[4] 
X 
X 
X 
X 
Biochemistry[5] 
X 
X 
X 
X 
Coagulation Indices 
X 
X 
X 
X 
Urinalysis 
X 
X 
X 
X 
Plasma HIV-1 RNA level[6] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TruCount T assay[7] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Trofile® DNA Assay 
X 
X[20] 
Trofile® RNA Assay 
X[20] 
HIV-1 Drug Resistance Assay [8] 
X 
X 
PRO 140 Administration 
− 
Group A (350mg SC) 
− 
Group B (525mg SC) 
− 
Group C (700mg SC) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Combination ART Regimen [9] 
X 
X 
X 
Injection Site Reaction Assessment [10] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Injection Site Pain Assessment (VAS)[11] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
PK sample for PRO 140[12] 
X 
X 
X 
X 
X 
X 
Anti-idiotypic antibodies to PRO 140[12] 
X 
X 
X 
X 
X 
X 
Measurement of treatment adherence[13] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Potential Biomarkers 
Immune Activation Markers[14] 
X 
X 
PhenoSense® Entry Assay[15] 
X 
X 
Quest Diagnostics Tropism Assay[16] 
X 

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Procedure/Assessments 
Treatment Phase (T17 – T48) 
In case of 
Treatment 
Failure 
Visit 
T17 
T18-21 
T22-25 
T26-29 
T30-33 
T34-37 
T38-41 
T42-45 
T46 
T47 
T48 
VF 
Window Period 
±3 days since last treatment 
CNS sub-study (n=20) 
CSF sample collection[17] 
X 
GU sub-study (n=20) 
Genital Secretion sample collection[18] 
X 
CCR5 Receptor Occupancy[21] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
CCR5 Genotyping [22] 
X 
X 
Foot Notes: 
[1] 
Symptom-directed physical examination at clinic visits. 
[2] 
The neurological assessment tool is based on the three question survey used by Simioni et al. (Simioni S, 2010). Additional neurological assessment modalities may 
be used as per Investigator’s discretion. 
[3] 
Post treatment vital signs (blood pressure, heart rate, respiration rate, and temperature) will be measured at clinic visit. 
[4] 
Hemoglobin, Hematocrit (HCT), Red Blood Cells (RBC), White Blood Cells (WBC) with total and differential count, Absolute Neutrophil Count (ANC) and platelets. 
[5] 
Serum Biochemistry 
Hepatic function indicators: total and direct bilirubin, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total protein, Lactate 
dehydrogenase (LDH) 
Renal function indicators: BUN, creatinine 
Electrolytes: sodium, potassium, chloride, calcium and bicarbonate 
Other: glucose (random), cholesterol (total) 
[6] 
Blood sample for plasma HIV-1 RNA level collected at least once every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41 and T42-45 visits when 
subject comes to clinic. 
[7] 
Blood sample for TruCount T assay collected at least once every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41 and T42-45 visits when subject 
comes to clinic. Assay includes: Absolute Lymphocytes, CD3 cell count, CD4 cell count, CD8 cell count, CD3%, CD4% and CD8% 
[8] 
Monogram Biosciences GenoSure Archive Assay will be performed at T48 visit. PhenoSense® GT (and PhenoSense Integrase and GeneSeq Integrase testing, if 
applicable), will be performed at the time of virologic failure. 
[9] 
Study subjects will re-initiate their previous antiretroviral regimen or an alternative regimen selected by their treating physician: (1) One week prior to the end of 48- 
week Treatment Phase, or (2) Anytime during the Treatment Extension Phase, if virologic failure occurs or have met any other criteria for discontinuation of study 
treatment as specified in the protocol. 
[10] Injection Site Reaction Assessment as assessed by Investigator (or designee) at the clinic visits and by visiting nurse or qualified medical professional during home 
visits. Injection Site Reaction Assessment will not be applicable if PRO 140 is self-administered by subjects at home. 
[11] Subject-perceived injection site pain will be assessed using the Pain Visual Analog Scale (VAS) prior to study treatment administration which evaluates average pain 
since last treatment. Injection Site Pain Assessment will not be applicable if PRO 140 is self-administered by subjects at home. 
[12] Blood sample collected at anytime between T18-21, T26-29, T34-37 and T42-45 visits followed by at T48 and VF visits. 
[13] Treatment adherence self-reported by subject at least once every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41 and T42-45 visits followed by 
at T48 and VF visits when subject comes to clinic 
[14] immune activation markers (CRP, IL-6, D-Dimer) 

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[15] Monogram Biosciences HIV-1 PhenoSense® Entry assay with AMD3100 (X4 inhibitor drug), Maraviroc and PRO 140 (R5 inhibitor drugs). Sample collected for 
Trofile DNA/RNA at Screening will be used to test PhenoSense® Entry for eligible/enrolled subjects at Baseline. 
[16] Quest Diagnostics HIV-1 Coreceptor Tropism with Reflex to Ultradeep Sequencing or HIV-1 Proviral Tropism. 
[17] To evaluate PRO 140 concentration and HIV-1 RNA level in cerebrospinal fluid (CSF) 
[18] To evaluate PRO 140 concentration and HIV-1 RNA level in genital secretions 
[19] Monogram Biosciences Trofile® DNA or RNA assay (or both) will be performed at the Virologic Failure Visit depending on the last known HIV-1 RNA levels 
[20] Should VF occur, Group A or Group B subjects may transition to high dose IP and continue in 48-week Treatment Phase 
[21] To assess the number CCR5 receptors on patients’ CD4 cell surface, and number and percentage of CCR5 receptors that are covered by PRO 140. Sites should not 
collect samples on Fridays, since InCellDx lab cannot receive samples on Saturdays. 
[22] No new sample collection needed. The residual whole blood sample collected for tropism assessment at Screening or at post-treatment visits will be used for testing of 
CCR5 genotyping (homozygous or heterozygous status). 

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Table 4-3: 
Schedule of Assessments –Follow-Up (FU) Phase 
(a) Subjects who do NOT experience Virologic Failure 
 
Procedure/Assessments 
Follow-Up Visit -1 
Follow-Up Visit -2 
NVF-FU1 
NVF-FU2 
Window Period 
2 weeks 
(±3 days) after T48 
4 weeks 
(±3 days) after T48 
Physical Examination 
X[1] 
X[1] 
Vital Signs 
X 
X 
Plasma HIV-1 RNA level 
X 
X 
TruCount T assay 
X 
X 
Anti-idiotypic Antibodies to PRO 140 
X 
Re-initiate combination Antiretroviral 
Therapy 
X 
X 
Adverse Events 
X 
X 
Concomitant Medications 
X 
X 
[1] 
Symptom-directed physical examination 
 
(b) Subjects who experience Virologic Failure 
• Short-Term Follow-Up Visits 
 
Procedure/Assessments 
Follow-Up Visit -1 
Follow-Up Visit -2 
Follow-Up Visit -3[1] 
VF-FU1 
VF-FU2 
VF-FU3 
Window Period 
4 weeks 
(±7 days) after VF 
visit 
8 weeks 
(±7 days) after VF 
visit 
12 weeks 
(±7 days) after VF 
visit 
Physical Examination 
X[2] 
X[2] 
X[2] 
Vital Signs 
X 
X 
X 
Plasma HIV-1 RNA level 
X 
X 
X 
TruCount T assay 
X 
X 
X 
Anti-idiotypic Antibodies to PRO 140 
X 
Re-initiate combination Antiretroviral 
Therapy 
X 
X 
X 
Adverse Events 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
[1] 
Subject will be followed up every 4 weeks until viral suppression is achieved (i.e., plasma HIV-1 RNA levels decline to 
< 50 copies/mL). Subject will undergo additional follow-up visits every 4 weeks beyond VF-FU3 visit (up to a 
maximum of 6 months after re-initiation of combination antiviral therapy), if viral suppression is not achieved at the end 
of VF-FU3 visit. 
[2] 
Symptom-directed physical examination 

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• Long-Term Follow-Up Visits 
 
Procedure/Assessments 
Long-Term Follow-Up 
Visit -1 
Long-Term Follow-Up 
Visit -2 
VF-6mFU 
VF-12mFU 
Window Period 
6 months (±1 month) 
after VF visit 
12 months (±1 month) 
after VF visit 
Adverse Events[1] 
X 
X 
Assessment of cART changes[2] 
X 
X 
Plasma HIV-1 RNA level 
X 
X 
TruCount T assay 
X 
X 
Trofile® DNA or RNA Assay[3] 
X 
X 
PhenoSense® Entry Assay[4] 
X 
X 
HIV-1 Drug Resistance Assay[5] 
X 
X 
 
[1] 
Only SAEs and any AE that is considered possibly or probably or definitely related to the IP by the investigator will 
be captured during the long term follow up phase. 
[2] 
Any changes to the combination antiretroviral regimen since the viral re-suppression is achieved. 
[3] 
Monogram Biosciences Trofile® DNA or RNA (or both) assay will be performed depending on last known HIV-1 
RNA levels. 
[4] 
Monogram Biosciences HIV-1 PhenoSense® Entry assay with AMD3100 (X4 inhibitor drug), Maraviroc and PRO 
140 (R5 inhibitor drugs). 
[5] 
Monogram Biosciences GenoSure Archive Assay or PhenoSense® GT (and PhenoSense Integrase and GeneSeq 
Integrase testing, if applicable), will be performed depending on last known HIV-RNA levels. 

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4.1 
SCREENING PHASE 
4.1.1 Pre-Screening 
Sites are encouraged to pre-screen subjects for study inclusion, evaluating HIV-1 DNA viral 
tropism prior to performing a full screening visit. Up to 15 clinical sites will be allowed to 
participate in this process. 
The subject will sign and date the pre-screening informed consent form (ICF) prior to any study- 
related pre-screening procedures. A unique identification number (pre-screening number) will be 
assigned to each subject who has provided written pre-screening informed consent. The pre- 
screening number will incorporate a three-digit Study Center number (PS301, PS302, PS303….) 
and a two-digit numeric ID assigned in successive order of consenting to pre-screening procedures 
after signing the pre-screening ICF at each center, beginning with 001 at each site (e.g. PS301-01 
or PS302-01). 
Once the pre-screening ICF has been signed, the following procedures and information will be 
obtained to confirm pre- eligibility including: 
• Review of prior medical records 
• Blood sample collection for HIV-1 Co-receptor tropism analysis by Monogram 
Biosciences 
A pre-screening log will be maintained to capture the following information: 
• Pre-screening number 
• Patient initials 
• Date pre-screened 
• Initial eligibility 
• Date of re-consent (for the full consent form) or reason for ineligibility 
 
4.1.2 Screening Visit 
The subject (or Legally Acceptable Representative (LAR)) will sign and date the informed consent 
form (ICF) and Health Insurance Portability Accountability Act (HIPAA) authorization (according 
to site policy and practices) prior to any study-related procedures. A unique identification number 
(screening number) will be assigned to each subject who has provided written informed consent. 
Note: Screening numbers are independent of pre-screening number, if pre-screening performed. 
The subject screening number will incorporate a three-digit Study Center number (301, 302, 

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303….) and a three-digit numeric ID assigned in successive order of entering the study after signing 
the ICF at each center, beginning with 001 at each site (e.g. 301-001 or 302-001). 
Subject Screening # : 
XXX 
- 
YYY 
XXX=Study Center 
YYY=Subject Numeric ID 
 
All study centers will be instructed to maintain the study-specific pre-screening, screening and 
enrollment logs at their sites. If a subject initially fails to meet inclusion/exclusion criteria and is 
later reconsidered for participation, the subject will be re-consented and assigned a new screening 
number at the time of re-screening. Subjects who fail their first screening attempt may be re- 
screened a maximum of once and may be enrolled if they are found to meet all inclusion and no 
exclusion criteria when re-screened. 
Once the ICF has been signed, screening procedures and information will be obtained to confirm 
subject eligibility including: 
• Detailed medical history (see Section 7.4), 
• Demographic information (see Section 7.3), 
• Prior and current medications review (see Section 7.5), 
• Physical examination (see Section 7.6), 
• Electrocardiogram (ECG) (see Section 7.7), 
• Body Weight & Height measurements (see Section 7.9) 
• Vital Signs (see Section 7.9), 
• Collection of Blood Specimens (see Section 7.10) for 
o Complete Blood Count 
o Biochemistry 
o Coagulation Indices [Prothrombin time (PT) and INR] 
o Hepatitis B surface antigen (HBsAg) 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
o HIV-1 co-receptor tropism (Trofile® DNA Assay) 
▪ CCR5 Genotyping will be tested using residual whole blood sample from 
tropism sample collected at Screening 
o HIV-1 Drug Resistance Assay (GenoSure Archive Assay) 

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o HIV-1 PhenoSense® Entry (Monogram BioSciences) 
o Serum pregnancy test, for female subjects of childbearing potential. Childbearing 
potential is defined as someone who is not surgically sterile or is not more than one 
year past complete cessation of menstrual cycles. 
o Blood sample for evaluation of potential biomarkers 
▪ HIV-1 co-receptor tropism (Quest Diagnostics Proviral DNA® Assay) 
• Collection of Urine Specimen for Urinalysis (see Section 7.10.15) 
 
All screening information will be fully documented in the subject’s medical records (i.e., source 
documents). 
• For consented subjects who do not meet eligibility criteria, a Screen Failure electronic Case 
Report Form (eCRF) will be completed. The Screen Failure eCRF will contain the following 
details: the subject identification number, the date of ICF signature, demographic 
information (see Section 7.3), and the reason for screen failure. No additional information 
will be required for subjects who fail screening. 
• For consented subjects who meet eligibility criteria, all required screening information will 
be transcribed onto the appropriate page of the eCRF. 
Eligible subjects that are not enrolled within 42 days of Screening Visit will have screening lab 
assessments repeated, with the exception of HIV-1 viral tropism, genotype and phenotype, to 
reconfirm eligibility. 
 
4.2 
TREATMENT PHASE 
Treatment Phase begins with an evaluation of results of laboratory samples collected during the 
Screening Phase. Subjects who meet all eligibility criteria, as per data gathered from Screening 
Phase are to be treated. All subjects who fail to meet eligibility criteria will be considered screen 
failure and exit the study without further evaluation. 
All subjects will continue their existing antiretroviral regimen for one week after receiving initial 
assigned dosing of PRO 140. Subjects will receive up to 48 weekly PRO 140 injections in the 
Treatment Phase, given once per week (± 3 days) or until virologic failure, whichever occurs first. 
The study treatment (PRO 140 350mg or 525mg or 700mg SC injections) will be administered by 
a qualified medical professional (MD, DO, PA, LPN, LVN, NP, RN or CMA if permitted by state 
law) at clinic site or home visit or self-administered by subjects, for the duration of 48 weeks in the 
Treatment Phase. 

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As shown in Table 4-4, eligible subjects will be randomized 1:1 to two treatment arms for 48 weeks. 
Table 4-4:   Part 1: Randomized, Two-Arm, Open-Label Treatment Phase 
 
Study Drug 
Dosage 
Form 
IP 
concentration 
Dosing Frequency and Amount 
Route of 
Administration 
GROUP A 
PRO 140 
350mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 X 1 mL/inj.) 
for 48 weeks 
SC injection 
GROUP B 
PRO 140 
525mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 X 1.5 mL/inj.) 
for 48 weeks 
SC injection 
GROUP C 
PRO 140 
700mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 X 2 mL/inj.) 
for 48 weeks 
SC injection 
 
As shown in Table 4-5, Group A subjects experiencing virologic failure (defined as two consecutive 
HIV-1 RNA levels of ≥ 200 copies/mL) in Part 1 of Treatment Phase will have option of reinitiating 
ART regimen or begin PRO 140 525mg SC weekly injections for remainder of 48-week Treatment 
Phase. 
Table 4-5:   Part 2: Single-Arm, Open-label Treatment Phase [Group A] 
 
Study Drug 
Dosage 
Form 
IP 
concentration 
Dosing Frequency and Amount 
Route of 
Administration 
PRO 140 
525mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 X 1.5 mL/inj.) 
up to Week 48 
SC injection 
As shown in Table 4-6, Group B subjects that elect to participate in Part 2 of Treatment Phase after 
experiencing virologic failure during Part 1 of Treatment Phase will receive PRO 140 700mg SC 
weekly injection for remainder of 48-week Treatment Phase. Should subject experience subsequent 
virologic failure in Part 2 of Treatment Phase, subject will complete Virologic Failure (VF) Visit 
assessments and then enter the Follow-up Phase of the study. 
Table 4-6:   Part 2: Single-Arm, Open-label Treatment Phase [Group B] 
 
Study Drug 
Dosage 
Form 
IP 
concentration 
Dosing Frequency and Amount 
Route of 
Administration 
PRO 140 
700mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 X 2 mL/inj.) 
up to Week 48 
SC injection 
Group A or Group B subjects that do not elect to participate in Part 2 of Treatment Phase and all 
Group C subjects who experience virologic failure (defined as two consecutive HIV-1 RNA levels 
of ≥ 200 copies/mL) at any time during the Treatment Phase will undergo the Virologic 

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Failure (VF) Visit assessments and then exit the Treatment Phase to enter the Follow-up Phase of 
the study. 
 
Subjects who do not experience virologic failure will enter the Follow-up Phase of the study at 
the end of 48-week Treatment Phase. 
All study subjects will re-initiate their previous antiretroviral regimen or an alternative regimen 
selected by their treating physician: 
• 
One week prior to the end of 48-week Treatment Phase, or 
• Anytime during the Treatment Phase, if virologic failure occurs or have met any other criteria 
for discontinuation of study treatment as specified in Section 5.2.1 of the protocol. Subjects will 
be allowed to continue PRO 140 monotherapy while waiting for new ART regimen to be 
constructed by the Investigator. 
 
Note: 
➢ Subjects may return to clinic for an additional blood draw in-between the clinic visits for 
plasma HIV-1 RNA levels, per the discretion of the Investigator. 
➢ Virologic failure is defined as two consecutive levels of ≥ 200 copies/mL. 
− Subjects in Group A that experience virologic failure have option of re-initiating ART 
regimen or participating in Part 2 of Treatment Phase and receive higher dose of PRO 140 
(525mg SC) weekly injection for remainder of 48-week Treatment Phase or until 
subsequent virologic failure event after viral re-suppression on higher dose. 
− Subjects in Group B that experience virologic failure have option of re-initiating ART 
regimen or participating in Part 2 of Treatment Phase and receive higher dose of PRO 140 
(700mg SC) weekly injection for remainder of 48-week Treatment Phase or until 
subsequent virologic failure event after viral re-suppression on higher dose. 
➢ Subjects who meet any criteria (other than virologic failure) for discontinuation of study 
treatment as specified in Section 5.2.1 of the protocol, will undergo T48 Visit assessments 
and enter the Follow-up Phase of the study. 
➢ Subjects who do not experience virologic failure will enter the Follow-up Phase of the study 
at the end of 48-week Treatment Phase. 
 
 
Visits during the Treatment Phase will commence on T1, i.e. the date of first treatment, with 
weekly visits (± 3 days) thereafter. The first Treatment Visit (T1) will take place as soon as HIV- 

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1 viral tropism, genotype and phenotype resistance results are available for review by 
Investigator, within 6 weeks of the Screening Visit. 
4.2.1 Treatment Phase: Treatment Visit-1 (T1) 
The following assessments will be performed at T1 visit, unless otherwise specified: 
Pre-Treatment 
• Confirmation of eligibility criteria by reviewing test results and other criteria assessments 
performed at Screening Visit (see Section 7.2 ) 
• Neurological Assessment (see Section 7.8) 
• Symptom-directed physical examination (see Section 7.6) 
• Change in concomitant medications (see Section 7.5) 
• Any changes in medical history since Screening Visit (see Section 7.4) 
• Vital Signs (see Section 7.9) 
➢ Note: Vitals will be taken twice: pre- and post-treatment. Post-Treatment Vital 
Signs will be assessed within 15 minutes following study treatment administration. 
• Collection of Blood Specimens (see Section 7.10) for 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
o CCR5 Receptor Occupancy (IncellDx Lab) 
o HIV Drug Resistance Assay 
o PK sample for PRO 140 
o Anti-idiotypic antibodies to PRO 140 
o Blood sample for evaluation of potential biomarkers [occurs at T1] 
▪ gp120 genotypes 
▪ Plasma HIV-1 RNA Single Copy Assay 
▪ Immune Activation Markers 
▪ PhenoSense® Entry Assay [performed at T1 using the blood sample 
collected for Tropism at Screening for subjects who are found eligible to be 
enrolled in the study] 
▪ CCR5 expression levels 

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▪ Quest Diagnostics Proviral DNA® Tropism Assay [if not performed at SV] 
• Cerebrospinal fluid (CSF) sample collection for Central Nervous System (CNS) sub-study 
(see Section 7.10.16) 
➢ Note: CSF sample should be collected at T1 (prior to first dose of PRO 140), 
visit for subjects participating in CNS sub-study. 
• Genital secretion sample collection for Genitourinary (GU) sub-study (see Section 
7.10.17) 
➢ Note: Genital secretion sample should be collected at T1 (prior to first dose of 
PRO 140) visit for subjects participating in GU sub-study. 
• Urine Pregnancy Test (see Section 7.10.8) 
 
 
Administration of PRO 140 
PRO 140 is administered as subcutaneous injection in the abdomen weekly. A total of 350mg or 
525 mg or 700mg (175 mg/mL) is delivered as two injections on opposite sides of the abdomen. 
The 350mg dose will be delivered as two injections of 1 mL each, 525mg dose will be delivered as 
two injections of 1.5 mL each or one injection of 3.0 mL, and 700mg dose will be delivered as two 
injections of 2 mL each. 
Note: All treatment injections must be administered by a qualified medical professional (MD, DO, 
PA, LPN, LVN, NP, RN or CMA if permitted by state law) at clinic site or home visit or self-
administered by subjects, for the duration of 48 weeks in the Treatment Phase. 
Post-Treatment 
• Injection Site Reaction Assessment (see Section 7.12) 
➢ Note: To assess injection site reactions, the Investigator will use the DAIDS AE 
grading table (refer to Section 17.3). 
• Assessment of Adverse Events (AE) (see Section 9) 
• Vital Signs (see Section 7.9) will be assessed within 15 minutes of study treatment 
administration. 
Note: Subjects will continue their existing antiretroviral regimen for one week after receiving initial 
dosing of PRO 140. 
4.2.2 Treatment Phase: Treatment Visit-2 (T2) to Treatment Visit-16 (T16) 
The following assessments will be performed at each visit, unless otherwise specified: 

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• Assess for any Adverse Events and changes in Concomitant medications (see Section 9 
and 7.5), 
• Symptom-directed physical examination (see Section 7.6), 
• Neurological Assessment (see Section 7.8) [occurs at T16] 
• Vital Signs (see Section 7.9) 
➢ Note: Post-treatment vital signs will be assessed within 15 minutes following study 
treatment administration 
• Collection of Blood Specimens (see Section 7.10) for 
o Complete Blood Count at T12 visit 
o Biochemistry at T12 visit 
o Coagulation Indices [Prothrombin time (PT) and INR] at T12 visit 
o CCR5 Receptor Occupancy (IncellDx Lab) 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
➢ Note: Blood sample for plasma HIV-1 RNA level, TruCount T Assay, and 
CCR5 Receptor Occupancy should be collected at T2, T4, T6, T8, T10, T12, 
T14 and T16 visits when subject comes to clinic. 
o Plasma HIV-1 RNA Single Copy Assay 
➢ Note: Blood sample for plasma HIV-1 RNA Single Copy Assay should be 
collected at T8 and T12 visits when subject comes to clinic. 
o Trofile DNA Assay and PhenoSense Entry Assay at T10 visit 
o PK sample for PRO 140 
o Anti-idiotypic antibodies to PRO 140 
➢ Note: PK and ADA blood sample should be collected at T1 (prior to first 
dose), T4, T8, T12 and T16 visits. 
 
• Collection of Urine Specimen for Urinalysis (see Section 7.10.15) at T12 visit 
 
• Measurement of treatment adherence (see Section 7.14) at T4, T8, T12 and T16 visits 
 
• Study Treatment Administration (PRO 140) 
Note: All treatment injections must be administered by a qualified medical professional 

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(MD, DO, PA, LPN, LVN, NP, RN or CMA if permitted by state law) at clinic site or home 
visit or self-administered by subjects, for the duration of 48 weeks in the Treatment Phase. 
• Injection Site Reaction Assessment (see Section 7.12) 
➢ Note: To assess injection site reactions, the Investigator will use the DAIDS AE grading 
table (refer to Section 17.3). 
• Subject-perceived Injection Site Pain Assessment (see Section 7.13) 
➢ Note: Subject-perceived injection site pain will be assessed using the Pain Visual 
Analog Scale (VAS) prior to study treatment administration assessing average pain at 
injection site since last treatment. 
• Cerebrospinal fluid (CSF) sample collection for Central Nervous System (CNS) sub-study 
(see Section 7.10.16) 
➢ Note: CSF sample should be collected at T4 visit for subjects participating in 
CNS sub-study. 
• Genital secretion sample collection for Genitourinary (GU) sub-study (see Section 
7.10.17) 
➢ Note: Genital secretion sample should be collected at T4 and T16 visits for 
subjects participating in GU sub-study. 
4.2.3 Treatment Phase: Treatment Visit-17 (T17) to Treatment Visit-48 (T48) 
The following assessments will be performed at each visit during the remaining 32 weeks of the 
Treatment Phase, unless otherwise specified: 
• Assess for any Adverse Events and changes in Concomitant medications (see Section 9 
and 7.5), 
• Symptom-directed physical examination (see Section 7.6), 
➢ Note: Complete physical examination at T48 
 
• Neurological Assessment (see Section 7.8) [occurs at T48] 
• Vital Signs (see Section 7.9) 
➢ Note: Post-treatment vital signs will be assessed within 15 minutes following study 
treatment administration 
• Electrocardiogram (ECG) (see Section 7.7) [occurs at T48] 

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• Collection of Blood Specimens (see Section 7.10) for 
o Complete Blood Count at least once every 12 weeks at T22-25, T34-37 and at T48 
visits 
o Biochemistry at least once every 12 weeks at T22-25, T34-37 and at T48 visits 
Coagulation Indices [Prothrombin time (PT) and INR] at least once every 12 weeks 
at T22-25, T34-37 and at T48 visits 
o CCR5 Receptor Occupancy (IncellDx Lab) 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
➢ Note: Blood sample for plasma HIV-1 RNA level and TruCount T Assay should 
be collected at T17 and at least once every four weeks between T18-21, T22- 
25, T26-29, T30-33, T34-37, T38-41, T42-45 and T48 visits when subject 
comes to clinic. 
o Trofile® DNA Assay [occurs at T48] 
o PK sample for PRO 140 
o Anti-idiotypic antibodies to PRO 140 
➢ Note: PK and ADA blood sample should be collected at least once every four 
weeks between T18-21, T26-29, T34-37 and T42-45 visits, and at T48 visits. 
o HIV-1 Drug Resistance Assay – GenoSure Archive [occurs at T48] 
o Blood sample for evaluation of potential biomarkers [occurs at T48] 
▪ Immune Activation Markers 
▪ PhenoSense® Entry Assay 
 
• Collection of Urine Specimen for Urinalysis (see Section 7.10.15) at least once every 12 
weeks at T22-25, T34-37 and at T48 visits. 
 
• Measurement of treatment adherence (see Section 7.14) 
➢ Note: At least once every four weeks between T18-21, T22-25, T26-29, T30-33, 
T34-37, T38-41 and T42-45 visits followed by at T48 and VF visits when 
subject comes to clinic. 
 
• Study Treatment Administration (PRO 140) 
Note: All treatment injections must be administered by a qualified medical professional 
(MD, DO, PA, LPN, LVN, NP, RN or CMA if permitted by state law) at clinic site or 

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home visit or self-administered by subjects, for the duration of 48 weeks in the Treatment 
Phase. 
• Injection Site Reaction Assessment (see Section 7.12) 
➢ Note: To assess injection site reactions, the Investigator will use the DAIDS AE grading 
table (refer to Section 17.3). 
• Subject-perceived Injection Site Pain Assessment (see Section 7.13) 
➢ Note: Subject-perceived injection site pain will be assessed using the Pain Visual 
Analog Scale (VAS) prior to study treatment administration assessing average pain at 
injection site since last treatment. 
• Re-initiate previous antiretroviral regimen or an alternative regimen selected by the 
treating physician at Week-47, if viral load remain suppressed. 
 
4.3 
VIROLOGIC FAILURE (VF) VISIT 
Virologic failure is defined as two consecutive levels of ≥ 200 copies/mL. 
Subjects in Group A or Group B that experience virologic failure have option of re-initiating ART 
regimen or participating in Part 2 of Treatment Phase and receive higher dose of PRO 140 weekly 
injection for remainder of 48-week Treatment Phase or until subsequent virologic failure event after 
viral re-suppression on higher dose. 
 
 
The following assessments will be performed for all subjects who experience virologic failure 
during the Treatment Phase, prior to entering Follow-up Phase: 
• Assess for any Adverse Events and changes in Concomitant medications (see Section 9 
and 7.5), 
• Complete Physical Examination (see Section 7.6), 
• Vital Signs (see Section 7.9), 
• Neurological Assessment (see Section7.8), 
• Electrocardiogram (ECG) (see Section 7.7) 
• Subject-perceived Injection Site Pain Assessment (see Section 7.13), 
• Collection of Blood Specimens (see Section 7.10) for 
o Plasma HIV-1 RNA level 
o TruCount T Assay 

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o Complete Blood Count 
o Biochemistry 
o Coagulation Indices 
o HIV Drug Resistance Assay (PhenoSense GT/Integrase) 
o HIV Trofile® RNA Assay 
o CCR5 Receptor Occupancy (IncellDx Lab) 
o Anti-idiotypic antibodies to PRO 140 
o PK sample for PRO 140 
o Blood sample for evaluation of potential biomarkers [occurs at T48] 
▪ Immune Activation Markers 
▪ PhenoSense® Entry Assay 
▪ Quest Diagnostics HIV Co-receptor Tropism Assay 
 
• CSF sample collection for CNS sub-study (see Section 7.10.16) 
➢ Note: CSF sample should be collected at VF visit for subjects participating in 
CNS sub-study. 
 
• Genital secretion sample collection for GU sub-study (see Section 7.10.17) 
➢ Note: Genital secretion sample should be collected at VF visit for subjects 
participating in GU sub-study. 
 
• Collection of Urine Specimen for Urinalysis (see Section 7.10.15) 
 
• Measurement of treatment adherence (see Section 7.14) 
• Re-initiate previous antiretroviral regimen or an alternative regimen selected by the treating 
physician 
 
4.4 
FOLLOW-UP PHASE 
The duration of follow-up depends on whether subject experiences virologic failure. 
• Subjects who experience virologic failure within the Treatment Phase will be assessed every 
4 weeks until viral suppression is achieved (i.e., plasma HIV-1 RNA levels decline to < 50 
copies/mL). Additionally, virologic failure subjects will return to clinic for long- term 
follow-up at 6 months and at one year from the time of the Virologic Failure (VF) Visit. 

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• Subjects who do not experience virologic failure at the end of the Treatment Phase, will be 
assessed every 2 weeks for total of 4 weeks. 
4.4.1 Follow-Up Visits 
4.4.1.1 Short-Term Follow-Up Visits 
4.4.1.1.1 Virologic Failure Subjects 
Subjects who experience virologic failure during the Treatment Phase will be assessed every 4 
weeks until the viral suppression is achieved (i.e., plasma HIV-1 RNA levels decline to < 50 
copies/mL). 
The following assessments will be performed at each follow-up visit (VF-FU1, VF-FU2, VF-FU3 
etc.), unless otherwise specified: 
• Assess for any Adverse Events and changes in Concomitant medications (see Section 9 and 
7.5), 
• Symptom-directed physical examination (see Section 7.6), 
• Vital Signs (see Section 7.9), 
• Collection of Blood Specimens (see Section 7.10) for 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
o Anti-idiotypic antibodies to PRO 140 (at Virologic Failure - FU1 and Non 
Virologic Failure - FU2) 
• Continue previous antiretroviral regimen or an alternative regimen selected by treating 
physician 
4.4.1.1.2 Non Virologic Failure Subjects 
Subjects who do not experience virologic failure at the end of the Treatment Phase, will be 
assessed every 2 weeks for total of 4 weeks. 
The following assessments will be performed at each follow-up visit (NVF-FU1 and NVF-FU2 
visits), unless otherwise specified: 
• Assess for any Adverse Events and changes in Concomitant medications (see Section 9 
and 7.5), 
• Symptom-directed physical examination (see Section 7.6), 
• Vital Signs (see Section 7.9), 

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• Collection of Blood Specimens (see Section 7.10) for 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
o Anti-idiotypic antibodies to PRO 140 (at Non Virologic Failure - FU2) 
• Continue previous antiretroviral regimen or an alternative regimen selected by treating 
physician 
4.4.1.2 Long-Term Follow-Up Visits 
Additionally, subjects who experience virologic failure will also return to clinic for the long-term 
follow-up at 6 months and at one year from the time of the Virologic Failure Visit. 
The following assessments will be performed at VF-6mFU and VF-12mFU visit, unless otherwise 
specified: 
• Assess for any Adverse Events and changes in combination antiretroviral therapy (see 
Section 9 and 7.5) 
➢ 
Note: Only SAEs and any AE that is considered possibly or probably or definitely 
related to the study treatment by the Investigator will be captured during the long- 
term follow-up phase. 
• Collection of Blood Specimens (see Section 7.10) for 
o Plasma HIV-1 RNA level 
o TruCount T Assay 
o HIV Drug Resistance Assay (GenoSure Prime or PhenoSense GT/Integrase) 
o HIV Trofile® DNA or RNA Assay 
o HIV PhenoSense Entry® Assay 

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5 
SUBJECT COMPLETION AND WITHDRAWAL 
 
5.1 
SUBJECT COMPLETION 
 
• A subject who completes the 48-week Treatment Phase and 4-week Non-Virologic 
Failure Follow-Up Phase will be considered as having completed the study. 
• A subject who experiences virologic failure during the 48-week Treatment Phase, and 
undergoes the Virologic Failure (VF) Visit assessments and is followed up until viral 
suppression is achieved and complete Virologic Failure – 12 month Follow-Up (VF- 
12mFU) Visit, will be considered as having completed the study. 
 
5.2 
SUBJECT WITHDRAWAL 
 
A subject who enters the Treatment Phase but does not complete the study, as defined in Section 
5.1, is considered to have prematurely withdrawn from the Study. 
All subjects have the right to withdraw at any point during treatment without prejudice to future 
care. It will be documented whether or not each subject completed the clinical study. If for any 
subject, study treatment or observations were discontinued, the reason(s) will be recorded. 
The Investigator can discontinue a subject at any time if it is considered medically necessary. 
In addition, subjects WILL be withdrawn from the study, in consultation with the Medical Monitor 
and the Investigator, if any of the following are met: 
• A subject is significantly non-compliant with the requirements of the protocol. 
• The Investigator determines that it is in the best interest of the subject. 
• Subject chooses to withdraw or is withdrawn due to an adverse event 
• Recurring Grade 2 study drug injection related AE at two consecutive visits 
• Occurrence of Grade 3 study drug injection related AE 
• A subject becomes pregnant 
Note: The pregnancy will be followed to term for safety follow-up. Relevant safety information 
collected after the study has completed will be reported as supplemental information. 
• Discontinuation of study by Sponsor 
Premature withdrawal from the study MAY occur if, in consultation with the Medical Monitor and 
the Investigator, any of the following are met: 
• A subject is treated with a prohibited medication. 

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• Major protocol violation 
 
5.2.1 Discontinuation of Study Treatment 
Discontinuation of study treatment (PRO 140) and resumption of previous or alternative 
antiretroviral regimen is recommended if: 
• Subject experiences virologic failure (defined as two consecutive HIV-1 RNA levels of ≥ 200 
copies/mL). 
Note: Subjects in Group A that experience virologic failure have option of re-initiating ART 
regimen or participating in Part 2 of Treatment Phase and receive higher dose of PRO 140 
(525mg SC) weekly injection for remainder of 48-week Treatment Phase or until subsequent 
virologic failure event after viral re-suppression on higher dose. 
Subjects in Group B that experience virologic failure have option of re-initiating ART regimen 
or participating in Part 2 of Treatment Phase and receive higher dose of PRO 140 (700mg 
SC) weekly injection for remainder of 48-week Treatment Phase or until subsequent virologic 
failure event after viral re-suppression on higher dose. 
 
• Develops AIDS-defining conditions as specified in Appendix I (Section 17.1) under which 
subject is unable to continue treatment with study drug (PRO 140), or subject require treatment 
with prohibited concomitant medications. 
• Shows signs or symptoms of clinically significant immunosuppression 
• Subject or the subject’s clinician wishes to restart ART. 
• Subject becomes pregnant. 
 
5.2.2 Data Collected for Withdrawn Subjects 
Patients may withdraw from the study or discontinue study treatment at any time; however, 
CytoDyn is dedicated to minimizing missing data in this study. It is therefore suggested that all 
patients, regardless of whether they continue to receive study treatment, continue within the 
study. 
Investigators considering discontinuing study treatment should contact the medical monitor prior 
to such discontinuation. Patients who have study treatment discontinued will continue to be 
followed, per protocol, whenever possible. Patients who have study treatment discontinued due 
to a serious adverse event will be followed until resolution or stabilization of the event. 
In the event that a subject is withdrawn from the study at any time due to an adverse event or serious 
adverse event (SAE), the procedures stated in Section 9.1.1 or 9.2.1, respectively must be followed. 

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Every attempt should be made to collect follow-up information. The reason for withdrawal from 
the study will be recorded in the source documents and on the appropriate page of the eCRF. 
Before a subject is identified as lost-to-follow up, the site should make all reasonable efforts to 
contact the subject. These attempts must be documented and should include at a minimum one 
phone call and one certified letter. 
 
5.3 
SCREEN FAILURES 
A subject who has signed a consent form, has been assigned a screening number, but is not treated 
is classified as a screen failure. Subject number, demographics and reason for screen failure will be 
recorded. 
If a subject initially fails to meet inclusion/exclusion criteria and is later reconsidered for 
participation, the subject will be re-consented and assigned a new screening number at the time of 
re-screening. Subjects who fail their first screening attempt may be re-screened again (i.e., up to 
two screenings) and may be enrolled if they are found to meet all inclusion and no exclusion criteria 
at the subsequent screening visit. 

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6 
STUDY TREATMENT 
 
6.1 
INVESTIGATIONAL PRODUCT DESCRIPTION 
PRO 140 is a humanized IgG4, monoclonal antibody (mAb) to the chemokine receptor CCR5. 
PRO 140 is provided at a concentration of 175 mg/mL and is intended for SC route of 
administration. 
Kits will be labeled with a unique identification number. Each kit used during the Treatment Phase 
will contain vials of PRO 140 for SC injection. One milliliter (1 mL), 1.5 mL, or 2 mL of PRO 140 
solution will be drawn from a vial and loaded into the syringe. A total of 350 mg or 525 mg or 700 
mg (175 mg/mL) of PRO 140 is delivered as two injections administered subcutaneously on 
opposite sides of the abdomen or as one of the alternative methods listed in Section 6.4 below. One 
study injection kit will be assigned per subject per treatment visit (with exception for 350 mg dose 
with 2.4 mL fill volume in which one kit can be used for two doses). 
 
PRO 140 Kits Containing 1.4 mL per Vial 
PRO 140 
Dose 
# of Vials 
Used per 
Dose 
Total 
Injection 
Volume (mL) 
Volume (mL) 
Administered 
per Injection* 
Volume (mL) 
Discarded per 
Vial 
350 mg 
2 
2 
1 
0.4 
525 mg 
3 
3 
1.5 
0.4 
700 mg 
4 
4 
2 
0.4 
PRO 140 Kits Containing 2.4 mL per Vial 
PRO 140 
Dose 
# of Vials 
Used per 
Dose 
Total 
Injection 
Volume (mL) 
Volume (mL) 
Administered 
per Injection* 
Volume (mL) 
Discarded per 
Vial 
350 mg 
1** 
2 
1 
0.4 
525 mg 
2 
3 
1.5 
0.9 
700 mg 
2 
4 
2 
0.4 
*When 2 injections given per dose; 1 injection on opposite sides of the abdomen. 

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**Since each vial contains 2.4 mL of PRO 140, only 1 vial is needed for the 350 mg dose. The 
second vial can be utilized to administer 350 mg dose at the subsequent visit. 
Each vial of the PRO 140 product contains ~1.4 or 2.4 mL antibody at 175mg/mL in a buffer 
containing 5 mM L-histidine, 15.0 mM glycine, 95 mM sodium chloride, 0.3% (w/v) sorbitol, 
0.005% (w/v) polysorbate 20 (Tween 20®), and sterile water for injection, at pH of 5.5. 
 
Table 6-1 provides the unit strength, dosing frequency and mode of administration for the study 
drug. 
Table 6-1: 
Investigational Product - PRO 140 
 
IP Dosage 
Dosage 
Form 
IP 
concentration 
Dosing Frequency and Amount 
Route of 
Administration 
PRO 140 
350mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (1 mL/inj.) 
per week on opposite sides of abdomen 
for up to 48 weeks (T1 – T48) 
SC injection 
PRO 140 
525 mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (1.5 mL/inj.) 
per week on opposite sides of abdomen 
for up to 48 weeks (T1 – T48) 
SC injection 
PRO 140 
700 mg 
Parenteral 
solution 
175 mg/mL 
2 injections of PRO 140 (2 mL/inj.) 
per week on opposite sides of abdomen 
for up to 48 weeks (T1 – T48) 
SC injection 
 
6.2 
INVESTIGATIONAL PRODUCT PACKAGING AND LABELING 
Study drug will be prepared by Ajinomoto Althea, Inc. and will be packaged, labeled, and shipped 
by Sherpa Clinical Packaging, LLC. 
The contents of each vial are described in Section 6.1. PRO 140 kits will be labeled with information 
such as: study protocol #; fill volume; concentration; storage condition; a “use as per study 
protocol” statement; a cautionary statement; sponsor’s name and address; and the kit number. 
Note: 1 mL injection will be drawn from 1.4 mL solution in a vial. Remaining 0.4 mL medication 
will be discarded appropriately from each vial. 
Subjects in Group B may require three vials and subjects in Group C may require four vials for 
single dose. Unused content of PRO 140 in a vial should remain in the vial and not be administered 
to any other subject. 
Alternatively, when 2.4 mL vials are provided, 1.5 or 2 mL injection will be drawn and the 
remaining will be discarded from each vial. Subjects in both group B and C will require two vials 
for a single dose. Unused content of PRO 140 in a vial should remain in the vial and not be 
administered to any other subject. 

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Below are representative samples of the Investigational Product, FDP individual vial (Figure 6-1), 
syringe label (Figure 6-2), and kit labels (Figure 6-3) designated for use in this clinical protocol. 
Each kit contains two labeled vials and two syringe labels. 
Figure 6-1:  PRO 140 (CHO) 175mg/mL - Vial Label 
 
Protocol: PRO 140_CD03 
Kit No. xxx 
Subject No.  
 
Single use 3 mL vial contains 1.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use 
CytoDyn Inc., Vancouver, WA, USA 
Protocol: PRO 140_CD03 
Kit No. xxx 
Subject No.  
 
Single use 3 mL vial contains 1.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use 
CytoDyn Inc., Vancouver, WA, USA 
 
Protocol: PRO 140_CD03 
Kit No. xxx 
Subject No.  
 
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use 
CytoDyn Inc., Vancouver, WA, USA 
Protocol: PRO 140_CD03 
Kit No. xxx 
Subject No.  
 
Single use 3 mL vial contains 2.4 mL of PRO 140 (175 
mg/mL) solution for subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) 
Law to Investigational Use 
CytoDyn Inc., Vancouver, WA, USA 
 
Figure 6-2:  PRO 140 (CHO) 175mg/mL - Syringe Label 
Note: Subjects in Group B will require a total of 3ml of study treatment for single dose, given as two 
1.5ml injections, three 1.0 injections, or one 3 mL injection. 
Subjects in Group C will require a total of 4ml of study treatment for single dose, given as two 2ml 
injections, or four 1 mL injections 
Protocol: PRO 140_CD03 
Contents of Kit No. xxx 
This syringe contains 1 mL, 1.5 mL, or 2 mL PRO 140 (175 mg/mL) solution for 
subcutaneous injection 
 
USE AS PER STUDY PROTOCOL 
 
Caution: New Drug – Limited by Federal (or United States) Law to 
Investigational Use 
 
CytoDyn Inc., Vancouver, WA, USA 

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Figure 6-3: 
PRO 140 (CHO) 175mg/mL - Kit Label 
 
 
 
 
 
Protocol: PRO 140_CD03 
 
Kit No. xxx 
Site No.  
 
Subject No.  
 
 
This kit contains 2 single-use vials 
Each 3 mL vial contains 1.4 mL of PRO 140 (175 mg/mL) solution for 
subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) Law to Investigational 
Use 
CytoDyn Inc., Vancouver, WA, USA 
Protocol: PRO 140_CD03 
 
Kit No. xxx 
Site No.  
 
Subject No.  
 
 
This kit contains 3 single-use vials 
Each 3 mL vial contains 1.4 mL of PRO 140 (175 mg/mL) solution for 
subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) Law to Investigational 
Use 
CytoDyn Inc., Vancouver, WA, USA 
Protocol: PRO 140_CD03 
 
Kit No. xxx 
Site No.  
 
Subject No.  
 
 
This kit contains 4 single-use vials 
Each 3 mL vial contains 1.4 mL of PRO 140 (175 mg/mL) solution for 
subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) Law to Investigational 
Use 
CytoDyn Inc., Vancouver, WA, USA 

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Note: Subjects in Group B will receive two injections of 1.5mL each of study treatment and subjects in 
Group C will receive two injections of 2mL each of study treatment for single dose. 
Patients with low body fat percentages may find subcutaneous injections uncomfortable esp. in case of 1.5 
mL or 2mL injection for the 525 mg or 700mg dosing, respectively. In such cases, PRO 140 525 mg can be 
injected as three 175mg/ml injections, or PRO 140 700 mg can be injected as four 175mg/ml injections 
and/or subcutaneous injections can be placed at different areas other than abdomen as per discretion of the 
Investigator. 
The pharmacy manual provides the criteria regarding vial acceptance or rejection, as well as 
instructions for the preparation of the IP syringes to be used to administer drug. 
 
6.3 
INVESTIGATIONAL PRODUCT STORAGE 
Study drug will be shipped at 2°C to 8°C (refrigerated [36°F to 46°F]) to the Investigator’s site. 
Upon receipt at the site, the responsible site staff or pharmacist should verify the integrity of the 
vials. Study drug should be stored at 2°C to 8°C (refrigerated [36°F to 46°F]). The contents of the 
vial should appear as a clear to opalescent, colorless to yellow solution; fine translucent particles 
may be present. This is normal. 
The Investigator must maintain an accurate record of the shipment, storage, and dispensing of the 
study drug in a drug accountability log. An accurate record including the date and amount of study 
drug dispensed for each subject must be available for inspection at any time. A study CRA assigned 
to monitor the investigational site will review these documents once study drug has been received 
by the investigational site. Study drug will be accounted for on an ongoing basis during the study. 
 
6.4 
INVESTIGATIONAL PRODUCT ADMINISTRATION 
Guidelines for dose preparation can be found in the pharmacy manual. 
Protocol: PRO 140_CD03 
 
Kit No. xxx 
Site No.  
 
Subject No.  
 
 
This kit contains 2 single-use vials 
Each 3 mL vial contains 2.4 mL of PRO 140 (175 mg/mL) solution for 
subcutaneous injection 
Store at 2oC to 8oC (36oF to 46oF) 
USE AS PER STUDY PROTOCOL 
Caution: New Drug – Limited by Federal (or United States) Law to Investigational 
Use 
CytoDyn Inc., Vancouver, WA, USA 

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PRO 140 will be provided to the administering personnel in single-use syringes prepared from vials 
of study drug stored at 2-8°C at the site pharmacy prior to use. Each of two syringes is filled to 
deliver 1.0 mL, if receiving 350mg dose (or 1.5 mL, if receiving 525mg dose or 2 mL, if receiving 
700mg dose) of study drug. 
Equivalent volumes of study drug will be administered subcutaneously on opposite sides of the 
abdomen. However, based on subject preference or investigator discretion, subjects receiving each 
of the doses can be administered using an alternate approach as follows: 
350mg Dose: 
• One 2 mL injection on one side of the abdomen. 
525mg Dose: 
• One 3 mL injection on one side of the abdomen. 
• Three 1 mL injections, two on one side of the abdomen and one on the other side. 
700 mg Dose: 
• Four 1 mL injections, on opposite sides of the abdomen, or other location. 
A 25-guage needle should be used to remove IP from vial and for administration to subjects, and 
drug should not be held in syringe for longer than 1 hour. 
IP should be administered slowly over 15 seconds per mL. 
Following each SC delivery of drug, careful examination will be made to assess the appearance of 
any study drug Injection Site Reactions (ISRs) as described in Section 17.3. 
All doses of study drug will be administered as SC injection by a qualified medical professional 
(MD, DO, PA, LPN, LVN, NP, RN or CMA if permitted by state law) at clinic site or home visit 
or self-administered by subjects. 
 
6.5 
INVESTIGATIONAL PRODUCT RECEIPT AND ACCOUNTABILITY 
Study drug must be used in accordance with this protocol and only under the direction of the 
responsible Investigator. The investigational site must maintain complete and accurate records 
showing receipt and disposition of all study drug, including master records listing the date of 
receipt, the number and nature of medication units received, and a dispensing record which includes 
each quantity dispensed, identification of the staff member/subject to whom dispensed, the date of 
dispensing, the intended study participant, and the identification of the preparer. All used and 
unused study kits will be retained by the investigational site until drug accountability can be 
confirmed by study CRA during the monitoring visits. Instructions will be provided by Sponsor 
regarding final disposition of all study drug in compliance with applicable regulations. 

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6.6 
INVESTIGATIONAL PRODUCT DISPOSITION 
All drug supplies are to be used only for this protocol and not for any other purpose. The 
Investigator must not destroy any drug labels or any partially used or unused drug supply until 
instructed by the Sponsor. At the conclusion of the study and as appropriate during the course of 
the study, the Investigator will return all used and unused drug containers and drug labels to the 
drug distributor as directed by the Sponsor. A copy of the completed drug disposition form will be 
sent to CytoDyn, Inc. or to its designee. 

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7 
DESCRIPTION OF PROTOCOL ASSESSMENTS AND PROCEDURES 
 
7.1 
INFORMED CONSENT 
Written informed consent will be obtained for this study by the Investigator or designee from all 
subjects before the performance of any protocol-specific procedure. This study will be conducted 
in accordance with the provisions of the Declaration of Helsinki. 
In obtaining and documenting informed consent, the Investigator must comply with applicable 
regulatory requirements and must adhere to Good Clinical Practice (GCP). The Investigator, or 
designee, must fully inform subjects of all pertinent aspects of the study. Before informed consent 
may be obtained, the Investigator, or a person designated by the Investigator, must provide the 
subject ample time and opportunity to inquire about details of the study and to decide whether or 
not to participate in the trial. All questions about the trial must be answered to the satisfaction of 
the subject. Prior to the subject’s participation in the trial, the written informed consent must be 
signed and personally dated by the subject and by the person who conducted the informed consent 
discussion. Authorization for release of protected health information must also be obtained, as per 
local policies. 
 
7.2 
ASSESSMENT OF ELIGIBILITY 
During the Screening Phase and at T1 Visit (prior to treatment administration), the Investigator 
must assess a subject’s continued suitability and eligibility for the trial. The Inclusion and Exclusion 
criteria of this Protocol are described in Sections 3.3.1 and 3.3.2. If the subject is not suitable or 
eligible for the trial then the subject will be a screen failure. 
7.2.1 Re-screening 
If a subject initially fails to meet inclusion/exclusion criteria, and is later reconsidered for 
participation, the subject will be re-consented and assigned a new screening number at the time of 
re-screening. Subjects who fail their first screening attempt may be re-screened a maximum of once 
and may be enrolled if they are found to meet all inclusion and no exclusion criteria when re-
screened. 
 
7.3 
DEMOGRAPHIC INFORMATION 
For the purposes of this study, demographic information will include: 
• Dates of ICF signature 
• Date of birth 
• Gender 

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• Race (American Indian/Alaskan Native, Asian, Black/African American, Native 
Hawaiian/Pacific Islander, Caucasian, or other) 
• 
Ethnicity (Hispanic/Latino or Not Hispanic/Latino) 
 
7.4 
MEDICAL HISTORY 
A medical history will be recorded during the Screening Phase and will include: 
• All ongoing medical conditions 
• Disease history (HIV), history of substance abuse, social history, blood transfusion history 
and any past surgeries 
• All previously resolved medical conditions related to HIV or which are relevant in the 
judgment of the Investigator 
• Any prior medical conditions that have resolved within the last year 
Events that emerge prior to the first treatment (T1) will be recorded in the medical history and not 
as AEs. Aside from being used to determine subject eligibility, this information will permit the 
Investigator to record the nature, duration and severity of any ongoing baseline medical conditions 
prior to the patient’s receiving investigational product (IP) treatment. 
Medical histories will be recorded using the body system categories outlined below: 
 
• Cardiovascular 
• Lymphatic 
• Respiratory 
• Hematologic 
• Gastrointestinal 
• Immunologic 
• Renal 
• Dermatologic 
• Hepatic 
• Psychiatric 
• Neurological 
• Genitourinary 
• Endocrine 
• Other 
 
For each relevant history, the following will be documented: 
• Disease/disorder/condition 
• Date of diagnosis 
• History status (resolved or ongoing) 
 
7.5 
PRIOR / CONCOMITANT MEDICATIONS AND NON-STUDY TREATMENTS 

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A complete history of antiretroviral therapies will be recorded in the source documents and on the 
appropriate page of the eCRF. 
In addition to this, all other medications and therapies administered or taken by the subject 
beginning 30 days prior to first Screening Visit and throughout the study will be recorded. Subjects 
must be questioned at each study visit concerning any new medications or changes in current 
medications including over-the-counter medication. 
For each medication and non-study treatment, the following will be documented: 
• Medication/treatment name (generic name may be used if trade name is unknown) 
• Dose, unit, and frequency of dosing (individual dosages, not total daily dose). 
o Note: Each new dose of medication should be recorded as a separate entry, with the 
exception of medications that are given on a sliding scale. For these, it is acceptable 
to enter the range of the dosage, including the start and stop dates for which the 
specified dosage range was used. 
• Route of dosing 
• Indication for use 
• The start date 
• The stop date (if medication/therapy is not ongoing) 
Please refer to Exclusion Criteria (Section 3.3.2) for a list of prohibited treatments and/or 
procedures. All other medications that are appropriate for the care of the subject may be prescribed. 
If concomitant medications are started during the study, the indication for the concomitant 
medication should be considered an AE. 
7.5.1 Excluded Medications and Therapies 
1. Use of concomitant antiretroviral therapy is NOT allowed during the Treatment Phase of the 
study EXCEPT for one week overlap of existing retroviral regimen and PRO 140 at the 
beginning of the study treatment and also one week overlap at the end of the treatment in 
subjects who do not experience virologic failure. Subject is allowed to re-initiate antiretroviral 
therapy during the Treatment Phase, if virologic failure occurs or if subject meets any other 
criteria for discontinuation of study treatment as specified in Section 5.2.1 of the protocol. 
2. Use of oral or parenteral corticosteroids (> 5 mg/day) is NOT allowed during the study, with 
the following exceptions: 
o Use of chronic systemic corticosteroids at replacement doses (e.g., < 5mg/day prednisone) 
AND use of inhaled, nasal, or topical steroids are allowed. 

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o Use of short course of systemic corticosteroids (Medrol pack) after T2 will only be allowed 
with prior approval from the sponsor. 
3. Use of radiation or cytotoxic chemotherapy, immunosuppressants and immunomodulating 
agents (e.g., interleukins, interferons) or agents with known anti-HIV activity (i.e., 
hydroxyurea, foscarnet) are NOT allowed during the study. 
4. Use of any non-FDA approved/investigational therapy 
 
7.5.2 Allowable Medications and Therapies 
All other medications/therapies that are not otherwise prohibited and, in the judgment of the 
Investigator, are required for proper medical care of the subject may be prescribed. 
 
7.6 
PHYSICAL EXAMINATION 
The complete physical examination will include routine examinations for the following: 
• General Appearance 
• Head, Ears, Eyes, Nose, Throat (HEENT) 
• Lymph Nodes 
• Heart/Cardiovascular abnormalities 
• Respiratory 
• Abdomen 
• Genitourinary 
• Musculoskeletal and Extremities 
• Neurologic abnormalities 
• Dermatologic abnormalities 
• Any other body system for which an abnormality is noted and which, in the opinion of the 
Investigator, is relevant to the safety of the subject or could impact safety or efficacy results 
for the subject; i.e., the abnormality is clinically significant (CS). 
Each abnormality will be recorded and the Investigator will record an assessment of its clinical 
significance. 
The complete physical examination will be conducted at the Screening Visit (SV), Treatment Visit 
48 (T48), and at Virologic Failure (VF) Visit. Only symptom-directed physical examination will be 
performed at treatment and follow-up visits conducted within the clinic, and at unscheduled visits 
within the Treatment and Follow-up Phases. 

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7.7 
ELECTROCARDIOGRAM 
A resting 12-lead ECG will be conducted at the Screening Visit (SV) and at T48 or Virologic Failure 
(VF) visit and the results will be evaluated by the Investigator. The following parameters will be 
recorded: ventricular rate (beats per minute), PR interval (msec), QRS interval (msec), QT interval 
(msec), and QTc interval (msec). Additionally, the Investigator will record the overall results of the 
ECG reading as either normal or abnormal, and as either not clinically significant or clinically 
significant. If abnormalities are observed, each will be recorded. 
Only those subjects who have normal or not-clinically significant results at the Screening Visit (SV) 
will be enrolled in this study. 
 
7.8 
NEUROLOGICAL ASSESSMENT 
Neurological assessment will be performed by the Principal Investigator or Study Coordinator at 
Treatment Visits 1, 16 and 48 (T1, T16, T48) and at Virologic Failure (VF) Visit. 
The neurological assessment tool is based on the three question survey used by Simioni et al. 
(Simioni S, 2010). Refer to Section 17.4 for further details. Additional neurological assessment 
modalities may be used as per Investigator’s discretion. 
 
7.9 
VITAL SIGNS (INC. HEIGHT AND WEIGHT) 
Vital signs will be collected at all study visits performed at the clinic. Vital signs collected during 
the Treatment Phase will be performed post-treatment, with the exception of pre-treatment vitals 
collected at T1, and assessed within 15 minutes following study treatment administration. 
The following vital signs will be collected at all visits, unless otherwise stated: 
• Height (at SV) 
• Weight (at SV, T48 and VF visits) 
• BMI (derived from the height and weight measurements; at SV, T48 and VF visits) 
• Seated blood pressure (taken after the subject has been seated for at least 5 minutes) 
• Heart Rate 
• Respiration Rate 
• Temperature 
 
7.10 CLINICAL LABORATORY ASSESSMENTS 
Blood and urine samples will be collected according to the time points in the schedule of 
assessments for analysis of the following parameters: 

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7.10.1 Routine CBC 
• Frequency of testing: At SV, T12, T22-25, T34-37, T48 or VF 
• Includes hemoglobin, hematocrit (HCT), red blood cell (RBC) count, white blood cell 
(WBC) count, WBC differential count (%), absolute neutrophils count and platelets count. 
7.10.2 Biochemistry 
• Frequency of testing: At SV, T12, T22-25, T34-37, T48 or VF 
• Biochemistry profile includes assessment of: 
Hepatic function indicators: total and direct bilirubin, alkaline phosphatase, aspartate 
aminotransferase (AST), alanine aminotransferase (ALT), total protein, LDH 
Renal function indicators: BUN, creatinine 
Electrolytes: sodium, potassium, chloride, calcium and bicarbonate 
Other: glucose (random), cholesterol (total) 
7.10.3 Coagulation Indices 
• 
Frequency of testing: At the Screening Visit, T12, at least once every 4 weeks between 
T22-25, T34-37, T48,and VF. 
• 
Prothrombin time (PT) and International Normalized Ratio (INR) 
 
7.10.4 Hepatitis B surface antigen (HBsAg) 
• Frequency of testing: At SV 
• To detect presence of Hepatitis B virus infection 
 
7.10.5 PK sample for PRO 140 
• Frequency of testing: At T1, T4, T8, T12, T16 and at least once every four weeks between 
T18-21, T26-29 and T34-37, T42-45 and at T48 and VF visits. 
7.10.6 Anti-idiotypic antibodies to PRO 140 
• Frequency of sample collection: At T1, T4, T8, T12, T16 and at least once every four weeks 
between T18-21, T26-29 and T34-37, T42-45 and at T48 and VF visits. Additionally, 
sample will be collected at Virologic Failure Follow-up Visit 1 (VF-FU1) and Non-
Virologic Failure Follow-up Visit 2 (NVF-FU2) 
7.10.7 Serum pregnancy test 
• Frequency of testing: At SV 

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• Only for female subjects of childbearing potential. Childbearing potential is defined as 
someone who is not surgically sterile or is not more than one year past complete cessation 
of menstrual cycles. 
7.10.8 Urine pregnancy test 
• Frequency of testing: At T1 prior to first treatment administration 
• A urine sample will be collected from female subjects of childbearing potential. This test 
will be performed at the study site using a commercially available kit. 
7.10.9 Plasma HIV-1 RNA level and TruCount T Assay 
• Frequency of testing: At SV, T1, T2, T4, T6, T8, T10, T12, T14, T16 and T17, at least once 
every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41, T42- 45, T48 
and at VF visits when subject comes to clinic. In addition, blood sample will also be 
collected at all Virologic Failure Follow-up (VF-FU) Visits or Non-Virologic Failure 
Follow-up (NVF-FU) Visits. 
• To assess antiretroviral therapeutic response to PRO 140 or cART regimen 
Note: Plasma HIV-1 RNA level will be measured using Human Immunodeficiency Virus 1 
(HIV-1), Quantitative, RNA (Taqman® Real-Time PCR) test. 
TruCount T Assay includes measurement of Absolute Lymphocytes, CD3 cell count, CD4 
cell count, CD8 cell count, CD3%, CD4% and CD8% 
7.10.10 HIV-1 Trofile® DNA Assay 
• Frequency of testing: At SV, T10, and T48 Visits. In addition, Trofile® DNA may also be 
collected at VF, VF-6mFU and VF12mFU Visits, if last known HIV-1 RNA level is 
<1000 copies/mL. 
• To assess HIV-1 co-receptor tropism. This test determines eligibility for CCR5 antagonist 
therapy for patients infected with HIV-1. Only those subjects who have exclusive CCR5- 
tropic virus will be eligible to participate in this study. 
• Unlike the standard Trofile® assay (which uses viral RNA), Trofile® DNA Assay can 
determine the coreceptor tropism of a patient’s HIV-1 strain when the patient's viral load is 
undetectable. 
7.10.11 HIV-1 Trofile® RNA Assay 
• Frequency of testing: At VF, VF-6mFU and VF12mFU Visits, if last known HIV-1 RNA 
level is >1000 copies/mL. 
7.10.12 HIV-1 Drug Resistance Assay 

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a. GenoSure Archive Assay 
GenoSure Archive assay provides HIV-1 antiretroviral drug resistance data when 
standard resistance testing cannot be performed due to inadequate plasma viral load. 
o Frequency of sample collection: At SV, T1, and T48. Additionally, at VF, VF- 
6mFU and VF12mFU Visits, if last known HIV-1 RNA level is <1000 copies/mL. 
b. PhenoSense® GT 
PhenoSense® GT is a combination resistance test for three classes of antiretroviral drugs 
(i.e., nucleoside/nucleotide, non-nucleoside, and protease inhibitors), that provides both 
phenotypic and genotypic results from the same blood sample (viral load ≥500 
copies/mL). 
o Frequency of sample collection: At VF, VF-6mFU and VF12mFU Visits, if last 
known HIV-1 RNA level is >1000 copies/mL. 
c. PhenoSense Integrase and GeneSeq Integrase testing 
PhenoSense Integrase and GeneSeq Integrase testing will be additionally performed in 
conjunction with PhenoSense® GT, if subject has past exposure to an integrase or in 
cases where complex drug resistance patterns is known or suspected. 
Samples for PhenoSense® GT (and PhenoSense Integrase and GeneSeq Integrase 
testing, if collected) will be stored at Lab and will be analyzed only if subject experiences 
virologic failure. 
7.10.13 Blood sample collection for evaluation of potential biomarkers 
7.10.13.1 
gp120 genotypes 
• Frequency of testing: At T1 visit 
• To assess the baseline gp120 genotypes from each enrolled subject to identify potential 
polymorphisms that may decrease PRO 140 susceptibility and may affect response to PRO 
140 
7.10.13.2 
Plasma HIV-1 RNA Single Copy Assay 
• Frequency of sample collection: At T1 prior to first treatment administration, T8 and T12 
visits 
• To assess antiretroviral therapeutic response to PRO 140 regimen 
 
7.10.13.3 
Immune Activation Markers 
• Frequency of testing: At T1, T48 and VF visit 

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• Immune activation markers (CRP, IL-6, D-Dimer) 
 
7.10.13.4 
PhenoSense® Entry Assay 
• Frequency of testing: At T1, T10, T48, VF, VF-6mFU and VF12mFU Visits 
o Note: PhenoSense® Entry will be performed at T1 using the blood sample collected for 
Tropism at Screening for subjects who are found eligible and enrolled in the study. 
• With AMD3100 (X4 inhibitor drug), Maraviroc and PRO 140 (R5 inhibitor drugs). 
 
7.10.13.5 
CCR5 expression levels 
• Frequency of testing: At T1 visit 
• Flow cytometry and the 2D7 MAb will be used to measure CCR5 expression levels on 
peripheral blood mononuclear cells (PBMCs) 
7.10.13.6 
Quest Diagnostics Tropism Assay 
• Frequency of testing: At SV or T1 and VF 
• Includes: 
➢ HIV-1 Coreceptor Tropism with Reflex to Ultradeep Sequencing or HIV-1 Proviral 
Tropism. 
The Quest Diagnostics HIV-1 coreceptor tropism test begins with standard Sanger 
sequencing of the third variable (V3) loop of the HIV-1 gene, the primary determinant 
of viral tropism. The next-generation DNA sequencing (ultradeep sequencing [UDS]) 
is performed if standard sequencing detects only R5 virus. HIV-1 Coreceptor Tropism, 
Proviral DNA test is used when the plasma viral load is < 1000 copies/mL. 
➢ CytoDyn is currently investigating the possibility of developing a more accurate test 
for detection of poor response to PRO 140 in patients with early breakthrough or 
virologic failure during the treatment phase of the study. 
7.10.13.7 
CCR5 Receptor Occupancy 
• To assess the number CCR5 receptors on patients’ CD4 cell surface. Of those CCR5 
receptors, the test will also assess the number and percentage of CCR5 receptors that are 
covered by PRO 140. 
• Frequency of testing: At T1, T2, T4, T6, T8, T10, T12, T14, T16, T17, and at least once 
every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41, T42-45, 
(when subject comes to clinic), at T48, and VF visits. 

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• Samples will be shipped overnight to IncellDx Lab. No samples should be collected on 
Fridays due to IncellDx Lab being closed Saturdays. 
7.10.13.8 
CCR5 Genotyping 
• To correlate the CCR5 homozygous or heterozygous status with virologic response to 
PRO 140 reported during the treatment phase. 
• No new sample collection is needed. The residual whole blood sample collected for 
tropism assessment at Screening or at post-treatment visits will be used for testing of 
CCR5 genotyping (homozygous or heterozygous status). 
7.10.14 Urinalysis 
• Frequency of testing: At the Screening Visit (SV), T12, T22-25, T34-37, T48 or VF visit 
• Urine samples will be tested for color, appearance, specific gravity, pH, protein, glucose, 
occult blood, ketones, leukocyte esterase, nitrite, bilirubin, urobilinogen, and microscopic 
examination of urine sediment 
7.10.15 CSF sample collection for CNS sub-study 
• Frequency of testing: At the T1 (prior to first dose of PRO 140), T4 and VF visits. 
• In a subset of participants (n=20) to assess the extent of PRO 140 entry into the CNS 
compartment, and to evaluate virologic responses in CSF. 
7.10.16 Genital Secretion sample collection for GU sub-study 
• Frequency of testing: At the T1 (prior to first dose of PRO 140), T4, T16 and VF visits. 
• In a subset of participants (n=20) to assess the extent of PRO 140 entry into the 
genitourinary compartment, and to evaluate virologic responses in genital secretion. 
All laboratory reports will be reviewed by the Investigator. 
Post-treatment abnormal results that are considered by the Investigator to be clinically significant 
will be recorded as adverse events. If the Investigator judges it necessary, testing may be repeated 
in order to make the determination of clinical significance. Validated, quality-controlled laboratory 
data will be transferred to the main database for analyses. 
 
7.11 PRO 140 ADMINISTRATION 
Refer to Section 6.4 for details. 
 
7.12 INJECTION SITE REACTION ASSESSMENT 

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At each treatment visit that occurs at the clinical site, an injection site reaction assessment will be 
made for the current and previous injection sites. Injection site reaction assessments are recorded 
by the Investigator starting after the first injection is given. Refer to Sections 9.1.8 and 17.3 for 
more details. 
 
7.13 PAIN ASSESSMENT USING VISUAL ANALOG SCALE (VAS) 
Tolerability of repeated subcutaneous administration of PRO 140 is evaluated based on assessment 
of subject-perceived injection site pain using the Pain Visual Analog Scale (VAS). This assessment 
will be performed each time subjects arrive to the clinic for the study visit. 
Beginning at Treatment Visit 2, subjects will be asked to mark the point that best represents the 
average pain intensity over the past week at the injection site on a horizontal line (100 mm in 
length) anchored by the following word descriptors at each end, “no pain" on the left side and "pain 
as bad as it could possibly be" on the right side of the line. The subject marks on the line or by 
pointing to a position on the line the point that they feel represents their perception of their pain 
state. The VAS score is determined by measuring in millimeters from the left-hand end of the line 
to the point that the patient marks. 
 
 
Figure 7-1:  Visual Analog Scale 
 
 
 
 
7.14 MEASUREMENT OF TREATMENT ADHERENCE 
Adherence to assigned regimen during Treatment Phase will be self-reported by subject at T4, T8, 
T12, T16, and once every four weeks between T18-21, T22-25, T26-29, T30-33, T34-37, T38-41 
and T42-45 visits followed by at T48 and VF visits when subject comes to clinic. 

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8 
STATISTICAL CONSIDERATIONS 
This section presents general information about statistical considerations and concepts such as 
statistical power, sample size, and a brief discussion on analysis methodology, as well as some data 
conventions. Detailed descriptions of the statistical analysis methods and data conventions that will 
be used in this study will be in a separate document; i.e., the Statistical Analysis Plan (SAP). 
 
8.1 
TREATMENT GROUPS 
All eligible subjects in the study will receive PRO 140 as a 350 mg or 525 mg or 700mg 
subcutaneous injection weekly for up to 48 weeks. 
 
8.2 
DESCRIPTION OF STUDY OUTCOME MEASURES 
8.2.1 Primary Safety Outcome Measures 
The following metrics will be analyzed to assess the clinical safety of PRO 140 monotherapy 
regimen: 
• Incidence of Treatment-Emergent Adverse Events (TEAE) 
• Incidence of Treatment-Emergent Serious Adverse Events 
• Incidence of Injection Site Reactions by Investigator evaluation 
• Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale 
• Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study 
participants (using Visual Analogue Scale) 
• Changes and shifts in laboratory measurements over time 
• Changes in vital signs and weight over time 
• Changes and shift in Electrocardiogram (ECG) parameters over time 
• Incidence of Physical Examination abnormalities over time 
8.2.2 Primary Efficacy Outcome Measures: 
• 
Proportion of participants experiencing virologic failure at the assigned dose 
Note: (1) Virologic failure is defined as two (2) consecutive plasma HIV-1 RNA levels of ≥ 
200 copies/mL. (2) Assigned dose refers to the dose allocated at the time of 
randomization/enrollment. 
• 
Time to virologic failure at the assigned dose 
• 
Proportion of participants moved to rescue arm or higher dose group 

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Note: Rescue is defined as subjects who were unable to maintain viral suppression, or 
experienced virologic failure, and moved to a higher dose of PRO 140 
• 
Proportion of participants achieving viral re-suppression (HIV-1 RNA <50 copies/mL) 
during Treatment Phase after moving to rescue arm or higher dose group 
• 
Time to achieving viral re-suppression (HIV-1 RNA <50 copies/mL) during Treatment 
Phase for subjects who moved to rescue arm or higher dose group 
• 
Proportion of participants achieving viral re-suppression (HIV-1 RNA <50 copies/mL) after 
experiencing virologic failure (during the Treatment and Follow-up Phase) 
• 
Time to achieving viral re-suppression (for virologic failure subjects) after re-initiation of 
oral combination antiretroviral regimen during the Follow-up Phase. 
• 
Proportion of participants completing 24, 48 weeks of PRO 140 treatment with HIV-1 RNA 
<50 copies/mL 
• 
Mean change in CD4 cell count, at each visit within the Treatment Phase 
• 
To evaluate the prognostic factors of therapeutic success of PRO 140 monotherapy during 
the Treatment Phase. 
a. CCR5 Receptor Occupancy 
b. CCR5 Genotyping Status 
c. gp120 genotyping 
d. Baseline HIV-1 RNA Single Copy levels 
e. Immune Activation Markers 
f. PhenoSense® Entry Assay 
8.2.3 Secondary Exploratory Outcome Measures: 
• Measurement of treatment adherence to the PRO 140 monotherapy regimen; this will be 
assessed using number of missed PRO 140 administrations 
• Loss of future drug options 
The first occurrence of intermediate to high level resistance to any one or more of the 
standard antiretroviral drugs to which the patient's virus was considered to be sensitive at 
trial entry (i.e. excluding drug resistance present at baseline). 
• Proportion of participants overall and within each treatment group experiencing emerging 
resistance exhibited by fold increase in maraviroc and PRO 140 FC (Fold Change in IC50 
and IC90 relative to wild-type virus) between baseline and the time of virologic failure, as a 
measure of post-baseline phenotypic resistance 
Note: Virologic failure is defined as two (2) consecutive plasma HIV-1 RNA levels of ≥ 200 
copies/mL. 

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Central Nervous System (CNS) sub-study: In a subset of participants (n=20): 
• Level of HIV-1 RNA in CSF at T1 (prior to first dose of PRO 140), T4 and VF visits 
• PRO 140 concentration in CSF at T1 (prior to first dose of PRO 140), T4 and VF visits 
• Relationship between PRO 140 concentration in plasma and CSF 
• Relationship between PRO 140 concentration in CSF and HIV-1 RNA in CSF 
• Relationship between plasma and CSF HIV-1 RNA suppression and HIV disease 
progression and safety parameters (i.e., adverse events and laboratory abnormalities) 
Genitourinary (GU) sub-study: In a subset of participants (n=20): 
• Level of HIV-1 RNA in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 
and VF visits. 
• PRO 140 concentration in genital secretion at T1 (prior to first dose of PRO 140), T4, T16 
and VF visits. 
• Relationship between PRO 140 concentration in plasma and genital secretion 
• Relationship between PRO 140 concentration and HIV-1 RNA in genital secretion, 
• Relationship between plasma and genital secretion HIV-1 RNA suppression and HIV 
disease progression and safety parameters (i.e., adverse events and laboratory abnormalities) 
8.2.4 Safety Assessments 
Safety measurements will include: 
• Tolerability of repeated subcutaneous administration of PRO 140 as assessed by study 
participants (using Visual Analogue Scale) and by Investigator-evaluation of injection site 
reactions. 
• Frequency of Grade 3 or 4 adverse events as defined by the DAIDS Adverse Event scale 
• Frequency of treatment–emergent serious adverse events 
 
8.3 
SAMPLE SIZE DETERMINATION AND RATIONALE 
Three hundred (300) subjects will be enrolled in this study. The sample size is selected on the 
basis of clinical judgment. 
 
8.4 
RANDOMIZATION AND BLINDING 
All subjects enrolled under this version of the protocol will be randomized in two treatment arms. 
The study is open label with no blinding requirements. 

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8.5 
INTERIM ANALYSIS 
The interim analysis will be directed and conducted by an independent DMC, which will include 
clinicians with expertise in HIV disease, a neurologist or psychiatrist and at least one biostatistician 
who is not otherwise involved in the trial. The iDMC will monitor the safety of the trial from the 
beginning and at approximately six month intervals based on enrollment thereafter. The main 
purpose of this IA is to ensure the safety of the subjects in the trial and to recommend whether the 
trial should be stopped early to protect the safety of the participants. 
The iDMC will closely monitor the following: 
• Virologic failure and viral re-suppression (after oral combination therapy is re-instituted). 
• Long-term safety follow-up data for one year after completion of treatment phase 
• In addition to other safety parameters, all baseline/post-treatment tropism, resistance, prognostic 
factors such as, HIV-1 RNA single copy assay, immune activation markers etc. and any 
potential cardiovascular events (that may occur from inflammatory bursts post-drug 
withdrawal) 
A detailed interim analysis plan will be prepared and presented to the DMC prior to the conduct of 
the interim analysis. 
The details of the IA, including the below bullet points, will be included in the Statistical Analysis 
Plan (SAP) for the study. 
• The goals of the IA 
• IA procedures for data preparation 
• IA procedures conduct of the analysis 
• Futility analysis and stopping rule 
• Data to be shared with the DMC 
• Information to be shared with the sponsor after the IA 
 
8.6 
GENERAL STATISTICAL CONSIDERATIONS 
8.6.1 Analysis Populations 
The Intent-to-Treat (ITT) population is defined as the set of subjects who were enrolled or 
randomized and have at least one dose of PRO 140. 
The Per Protocol (PP) population is defined as the set of subjects who meet the ITT population 
requirements, and were not associated with a major protocol violation. 
The Safety population is defined as all subjects who received at least one dose of PRO 140. This 
population will be used for the analysis of safety parameters. 

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8.6.2 Statistical Methods 
All collected study data will be presented in subject data listings. Statistical analyses will be 
performed using SAS® for Windows, version 9.3 or later. 
A SAP will be developed and approved before the database is locked. The SAP will present the 
detailed statistical methodology to be used in analyzing the efficacy and safety data from this trial. 
8.6.3 Prognostic Factors/Covariates 
There are no pre-planned covariates analyses of the data from this study, other than the baseline of 
the dependent variable (i.e., Baseline CD4 cell counts for assessing changes in CD4) 
8.6.4 Handling of Missing Data 
For the per protocol analyses of efficacy outcome measures there will be no imputation of missing 
data. However, missing data will be imputed using different methods that will be detailed in the 
SAP for the ITT population of the primary and secondary outcome measures. 
8.6.5 Multicenter Study 
This is a multicenter clinical trial. 
 
8.7 
DATA SUMMARY 
8.7.1 Subject Disposition 
The disposition of all subjects who sign an ICF will be provided. The number of subjects screened, 
received treatment, completed, and discontinued during the study, as well as the reasons for all post 
treatment discontinuations will be summarized. Disposition and reason for study discontinuation 
will also be provided as a by-subject listing. 
8.7.2 Demographic and Baseline Characteristics 
Demographics and baseline characteristics (i.e., Age, Gender, Time since HIV diagnosis, Viral 
load at Screening Visit, etc.) will be summarized using appropriate descriptive statistics. 
Medical history of the subjects will also be provided as a by-subject listing. 
 
8.7.3 Prior and Concomitant Medications 
Prior and concomitant medications will be summarized for the Safety population. All prior and 
concomitant medications recorded in the eCRFs will be coded to generic term and all matching 
Anatomic Therapeutic Classification (ATC) codes using WHO Drug Summaries will be prepared 
using the coded terms. All prior and concomitant medications recorded in the eCRFs will also be 
listed. 

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8.7.4 Efficacy Analysis 
All data from the primary and secondary outcome measures will be summarized and tabulated 
according to the variable type: 
• Time to event data will be depicted using Kaplan-Meier plots 
• Continuous data summaries will include number of observations, mean, standard 
deviation, median, and minimum and maximum values. 
• Categorical data summaries will include frequency counts and percentages. 
 
8.7.4.1 Primary Analysis 
Primary Analysis of the primary and secondary outcome measures will be conducted on the ITT 
population. A statistical analysis plan will be developed to detail the statistical methods used for 
the primary analysis. 
8.7.4.2 Supportive Analysis 
To assess the consistency of the Primary Analysis results, supportive analysis will be conducted 
using the PP population. Statistical methodology for the supportive analyses will be the same as 
that of the primary analysis, with the exception of the analysis population used. The PP population 
will be used for the supportive analysis while the ITT population will be used for the primary 
analysis. 
8.7.5 Safety Analysis 
The Safety population will be used for the analysis of safety assessments. 
For continuous variables data will be summarized using n, mean, Standard Deviation (SD), 
minimum and maximum values. For categorical variables data will be summarized using frequency 
and percentage. 
8.7.5.1 Adverse Events 
Adverse events will be coded using Medical Dictionary for Regulatory Activities (MedDRA). 
TEAEs are defined as events with an onset on or after the first treatment. TEAEs will be 
summarized by treatment group, System Organ Class, and preferred term. The following TEAE 
summaries will be provided: 
• TEAEs by severity grade 
• TEAEs by relationship to study treatment. 
In addition, separate summaries of SAEs, and AEs resulting in discontinuation of study treatment 
will be presented. 
8.7.5.2 Tolerability Assessment 

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All data from tolerability assessments of repeated subcutaneous administration of PRO 140 as 
assessed by study participants (using Visual Analogue Scale) and by Investigator-evaluation of 
injection site reactions will be summarized. 
8.7.5.3 Clinical Laboratory Data 
All laboratory values will be listed. Laboratory measurements will also be summarized. 
 
8.7.5.4 Physical Examination 
All physical examination findings will be listed and any abnormality will be summarized. 
 
8.7.5.5 Vital Signs 
All vital sign assessment findings will be listed and summarized. 
 
8.7.5.6 ECG Examination 
All ECG examination findings will be listed and any abnormality will be summarized. 
 
8.7.5.7 Neurological Assessment 
All neurological assessment findings will be listed and any abnormality will be summarized. 

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9 
ADVERSE EVENTS (DEFINITIONS AND REPORTING) 
The Investigator is responsible for the detection and documentation of events meeting the criteria 
and definition of an AE or SAE, as provided in this protocol. During the study when there is a safety 
evaluation, the Investigator or site staff will be responsible for detecting, documenting, and 
reporting AEs and SAEs as detailed in this section of the protocol. 
 
9.1 
ADVERSE EVENT 
An adverse event (AE) is defined as any unfavorable or unintended sign, symptom, or disease that 
occurs or is reported by the subject to have occurred, or a worsening of a pre-existing condition. 
An AE may or may not be related to the study treatment. 
AEs will be elicited through direct questioning and subject reports. Any abnormalities in visit 
evaluations, physical examination findings or laboratory results that the Investigator believes are 
clinically significant to the research subject and that occurred after initiation of the first study 
treatment will be reported as AEs. Abnormal findings that are NOT clinically significant (NCS) 
should not be recorded as an AE. 
9.1.1 Reporting of Adverse Events 
Report initiation for all AEs and SAEs will begin at the time of the first treatment visit and continue 
up until the final study visit (i.e. up to NVF-FU2 for subject who do not experience virologic failure 
or until viral suppression is achieved for subjects who experience virologic failure). Additionally, 
virologic failure subjects will have a long-term follow-up visits at 6 months and at one year from 
the time of the Virologic Failure Visit. Only SAEs and any AE that is considered possibly or 
probably or definitely related to the study treatment by the Investigator will be captured during the 
Long-term Follow-up Phase of the study. All events will be followed to resolution or until 30 days 
after the subject completes the study. A final assessment of outcome will be made at that time. 
All AEs must be recorded in the subject’s medical records and on the eCRFs. AEs will be reported 
using customary medical terminology along with the following information: the onset and end 
dates, whether the event is considered to be a SAE (see Section 9.2), the impact the event had on 
study treatment (see Section 9.1.2 ), the DAIDS AE grade (intensity) of the event (see Section 
9.1.3), the causality of the event (see Section 9.1.4), whether treatment was given as a result of the 
event (see Section 9.1.5), and the outcome of the event (see Section 9.1.6). 
9.1.2 Impact of Study Treatment 
The impact the event had on the study treatment will be assessed as either: none, study treatment 
interrupted, study treatment discontinued, or not applicable. The “not applicable” assessment will 

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be used only when the subject is no longer in the treatment phase of the protocol, or if the outcome 
of the event was “death”. 
9.1.3 DAIDS AE Grade (Severity) Assessment 
The Investigator will carefully evaluate the comments of each subject and the response to treatment 
in order to judge the true nature and severity of the AE. The question of the relationship of AEs to 
study drug should be determined by the Investigator after thorough consideration of all available 
facts. To assess severity, the Investigator will use the DAIDS AE grading table (for adverse events 
as well as any injection site reactions refer to Section 17.2 and Section 17.3). 
The general guidelines for assessing the AE grade appear below. Full guidelines may be obtained 
at http://rsc.tech- 
res.com/Document/safetyandpharmacovigilance/DAIDS_AE_Grading_Table_v2_NOV2014.pdf. 
 
Table 9-1: 
DAIDS AE Grading General Guidelines 
 
Grade 
Description 
Grade 1 
indicates a mild event 
Grade 2 
indicates a moderate event 
Grade 3 
indicates a severe event 
Grade 4 
indicates a potentially life-threatening event 
Grade 5 
Death related to AE. 
DAIDS AE Grading Table Version 2.0- November 2014 
 
 
9.1.4 Causality Assessment 
Adverse events will be assigned a relationship (causality) to the study treatment. The Principal 
Investigator (PI) must review each AE and make the determination of relationship of the event to 
the study treatment. Relationship of AEs to study treatment will be classified as follows: 
1. Definitely related: This category applies to those AEs that the Investigator feels are 
incontrovertibly related to the study treatment. An AE may be assigned an attribution of 
definitely related if or when it meets all of the following criteria: (1) it follows a reasonable 
temporal sequence from administration of the study treatment; (2) it could not be reasonably 
explained by the known characteristics of the subject’s clinical state, environmental or toxic 
factors, or other modes of therapy administered to the subject; (3) it follows a known 
response pattern to treatment with the study treatment. 
2. Probably related: This category applies to those AEs which, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to be 
related to the study treatment. An AE may be considered probable if or when (must have 

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three): (1) it follows a reasonable temporal sequence from administration of the study 
treatment. (2) It could not readily have been produced by subject’s clinical state, 
environmental or toxic factors, or other therapies administered to the subject. (3) Disappears 
or is decreased upon discontinuation of the study treatment. (4) It follows a known response 
pattern to treatment with the study treatment. 
3. Possibly related: This category applies to those AEs which, after careful medical 
consideration at the time they are evaluated, are judged unlikely but cannot be ruled out 
with certainty to the study treatment. An AE may be considered possible if or when (must 
have two): (1) it follows a reasonable temporal sequence from administration of the study 
treatment. (2) It could not readily have been produced by subject’s clinical state, 
environmental or toxic factors, or other therapies administered to the subject. (3) Disappears 
or is decreased upon discontinuation of the study treatment. (4) It follows a known response 
pattern to treatment with the study treatment. 
4. Remotely related: In general this category can be considered applicable to those AEs 
which, after careful medical consideration at the time they are evaluated, are judged likely 
to be unrelated to the study treatment. An AE may be considered unlikely if or when (must 
have two): (1) it does not follow a reasonable temporal sequence from administration of the 
study treatment. (2) It could not readily have been produced by subject’s clinical state, 
environmental or toxic factors, or other therapies administered to the subject. (3) Disappears 
or is decreased upon discontinuation of the study treatment. (4) It does not follow a known 
response pattern to treatment with the study treatment. 
5. Unrelated: This category applies to those AEs which, after careful consideration at the time 
they are evaluated, are clearly and incontrovertibly due to extraneous causes (disease, 
environment, etc.) and determined with certainty to have no relationship to the study 
treatment. 
9.1.5 Treatment Given as a Result of the Event 
The event impact in terms of treatment provided will be as either: none, medication administered, 
non-medication therapy administered, surgery, or other (with a specification). 
9.1.6 Outcome Assessment 
The outcome of the event will be assessed as either: resolved, resolved with sequelae, ongoing, or 
death. Only one AE per subject is allowed to have an outcome assessment as “death.” If there are 
multiple causes of death for a given subject, only the primary cause of death will have an outcome 
of death. 

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9.1.7 Expected / Anticipated Adverse Events 
The most common potential study drug-related adverse reaction reported is mild headache. Other 
adverse events likely to be related to the drug include mild to moderate diarrhea, nausea, and fatigue. 
9.1.8 SC Injection-related Events 
SC and IV injections of concentrated protein materials can be associated with injection-related AEs 
that impact the ability to safely and successfully deliver the drug. Local injection-site reactions may 
include pain/discomfort, induration, erythema, nodules/cysts, pruritus, ecchymosis, etc. For SC 
injections, bleeding, absorption of the drug, leakage of drug, and induration at the local injection 
site can be additional complications. Other AEs that are common to monoclonal antibody-based 
therapies are chills, headache, backache, malaise, fever, pruritus, rash, nausea, tingling, and 
hypertension. 
SC injection-related events will be monitored according to the guidelines provided in Section 17.2 
(Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events [DAIDS 
AE Grading Table]). Injection-site reactions thought to be directly related to the injection are 
considered to be AEs of special interest, and a separate guideline for the acquisition of data related 
to this AE of special interest is provided in Section 17.3. 
For subjects who develop grade 1 event or first occurrence of grade 2 event, continue therapy as 
per protocol. If a subject chooses to discontinue study treatment, the site should notify the protocol 
team leadership, and encourage the subject to complete any remaining study visits until the toxicity 
resolves. 
For subjects who develop grade 2 events following study drug injection, the subject should be 
reevaluated closely until the AE returns to Grade ≤1, at which time study treatment may be 
reintroduced at the discretion of the site Investigator. If the same Grade 2 AE recurs following the 
next administration of study drug, study treatment must be permanently discontinued. Subjects 
experiencing Grade 3 AEs requiring permanent discontinuation of study treatment should be 
followed closely for resolution of the AE to Grade ≤ 2 and the team leadership must be notified. 
Subjects with Grade 3 asymptomatic laboratory abnormalities in cholesterol, creatine kinase (CK) 
or triglycerides may continue study treatment. 
For grade 4 events permanently discontinue therapy. 
 
9.2 
SERIOUS ADVERSE EVENTS (SAE) 
A SAE is defined as any AE that: 
• Results in death 

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• Is life threatening (the subject is at immediate risk of dying from the AE) 
 
• Requires subject hospitalization or prolongs existing hospitalization 
 
• Results in persistent or significant disability/incapacity 
 
• Is a congenital anomaly/birth defect 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered a serious adverse event when, based upon appropriate medical judgment, they 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
If a pregnancy occurs in a subject or partner of a male subject during the study, it must also be 
reported to CytoDyn, Inc. Any pregnant subject must be followed up by the Investigator or designee 
until the child is born. Any complication experienced through the end of the pregnancy should be 
considered as an adverse event (AE), and should be recorded, and if it meets the seriousness criteria, 
it must be reported to CytoDyn, Inc/designated CRO promptly. Participants who become pregnant 
will be entered into the Antiretroviral Pregnancy Registry (http://www.apregistry.com). 
9.2.1 Reporting of Serious Adverse Events 
The Investigator is required to report all SAEs that occur during the time period specified in Section 
9.1.1. Once the Investigator becomes aware of an SAE, the SAE should be submitted to Amarex 
Safety Department within 24 hours: 
 
CRO Medical Monitor 
Attn: Shide Badri, MD 
Amarex Clinical Research, LLC 
20201 Century Boulevard, 4th Floor 
Germantown, MD 20874 
Email: saereporting@amarexcro.com 
Phone: +1 (240) 454-6844 
Fax: +1 (240) 454-6602 
The Amarex Medical Monitor may request additional supporting documentation as it becomes 
available, such as lab reports, ECG reports, discharge summary, hospital notes, etc. 
The Investigator is also responsible for reporting all SAEs to the appropriate Institutional Review 
Board (IRB) in accordance with local laws and regulations. The Investigator is responsible for 
maintaining documentation in the study file that indicates the IRB has been properly notified. Under 
21 CFR 312.32(c), the sponsor is required to notify FDA and all participating investigators in an 
IND safety report (i.e., 7- or 15-day expedited report) of potentially serious risks from 

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clinical trials or any other source as soon as possible, but no later than 15 calendar days after the 
sponsor receives the safety information and determines that the information qualifies for reporting. 
Participating investigators include all Investigators to whom the sponsor is providing drug under 
any of its INDs or under any investigator’s IND (21 CFR 312.32(c)(1)). 
9.2.2 SAE Follow-Up 
All subjects experiencing an SAE, including the discontinued subjects, must be closely followed 
until sufficient information is obtained to indicate a return to normal status or until the event 
stabilizes at a level acceptable to the Investigator (i.e., recovery, return to baseline status, no further 
improvement expected, or death). 
For each SAE indicated as an unresolved event on the initial report, regardless of whether the 
subject completed the study or withdrew, the site should submit a follow-up report with updated 
information. 

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10 DIRECT ACCESS TO SOURCE DATA/DOCUMENTATION 
Subjects will be identified on eCRFs by a unique subject identification number and on source 
documents by name and date of birth. No personal identifier will be used in any publication or 
communication used to support this research study. The subject identification number will be used 
if it becomes necessary to identify data specific to a single subject. 
The monitors, auditors, personnel authorized by the Sponsor, the local IRB, and the FDA are 
eligible to review medical and research records related to this study as a part of their responsibility 
to protect human subjects in clinical research and will be given direct access to source data and 
documentation (e.g., medical charts/records, printouts etc.) for source data verification, provided 
that subject confidentiality is maintained in accordance with local requirements. Access to 
electronic medical records may be governed by institution policy and each site will be required to 
ensure access while remaining compliant with institutional requirements. 

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11 QUALITY CONTROL AND QUALITY ASSURANCE 
 
11.1 MONITORING REQUIREMENTS 
In an effort to fulfill the obligations outlined in 21 Code of Federal Regulations (CFR) Part 312 and 
ICH guidelines which requires the Sponsor to maintain current personal knowledge of the progress 
of a study, the Sponsor's designated monitor will visit the center(s) during the study as well as 
maintain frequent telephone and written communication. The Investigator will permit the Sponsor 
to monitor the study as frequently as is deemed necessary and provide access to medical records to 
ensure that data are being recorded adequately, that data are verifiable and that protocol adherence 
is satisfactory. 
The Investigator will permit representatives of the Sponsor and/or designated CRO to inspect all 
eCRFs and corresponding study subject original medical records (source documents) at regular 
intervals throughout the study. Subject original medical records and other relevant data must be 
available to support all data recorded in the eCRF. In addition to the original medical records, these 
data may include but are not limited to, study, laboratory and diagnostic reports, neurological 
assessment results, etc. 
Site inspections serve to verify strict adherence to the protocol and the accuracy of the data being 
entered on the case report forms, in accordance with federal regulations. A Monitoring Log will be 
maintained at each study site which the monitor will sign, date and state the type of visit. 
The Investigator should be aware that the study site and subject records may be inspected by the 
Sponsor and or representatives of the designated CRO, FDA or other regional regulatory authority. 
For the IA, a cut-off date for data collection and monitoring will be determined and sites will be 
requested to provide current information up to the cut-off date. 
11.2 ACCEPTABILITY OF CASE REPORT FORMS (CRFS) 
Electronic CRFs must be completed for each subject who has signed an informed consent form. For 
subjects who are screen failures, this would be limited to the screen failure eCRF page. All source 
documents and eCRFs will be completed as soon as possible after the subject's visit. Corrections to 
data on the eCRFs will be documented. The Investigator will review eCRFs to indicate that, to 
his/her knowledge, they are complete and accurate. Electronic CRFs will be reviewed by the 
Sponsor’s or designated CRO’s monitor, who will make a decision as to their acceptability. 
11.3 MODIFICATION OF PROTOCOL 
The Investigator will not modify or alter this protocol without first obtaining the concurrence of the 
Sponsor. 

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Approval by the Investigator’s IRB must also be obtained prior to implementation of the change, 
with two exceptions: 
1. When necessary to eliminate apparent immediate hazard to the subject; or 
2. When the modification does not involve the subject’s participation in the trial. 
An amendment may also require modification of the informed consent form. The Investigator will 
provide an approval letter for the amendment and revised informed consent form, if applicable, to 
the Sponsor. An amendment must be in writing and it must be dated by both the Sponsor and the 
Investigator. If necessary, the Sponsor will submit protocol amendments to FDA and other 
appropriate regulatory authorities and notify other Investigators using this protocol. 
 
11.4 REPORTING PROTOCOL DEVIATIONS 
The Investigator is obligated to follow the protocol without departure from the requirements written 
in the protocol. If the Investigator deviates from the protocol requirements, the Sponsor will make 
the determination as to whether the subject will continue in the study. The Sponsor also has the 
right to discontinue the subject for protocol violations. The IRB may also have to be contacted if 
safety to the subject or if the scientific soundness of the study is involved. All protocol deviations 
must be documented in the eCRFs. 

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12 DATA MONITORING COMMITTEE (DMC) 
The study will be monitored by an independent DMC (DMC) to ensure patient safety and to assess 
efficacy. The CRO is responsible for the overall management of DMC, including development of 
its charter and membership selection. The DMC will be managed in conformance with the FDA 
guidelines for DMC independence, management, and oversight. 
The DMC will monitor the safety of the trial from the beginning and at approximately six month 
intervals thereafter based on enrollment. In addition, an Interim Analysis (IA) will be conducted 
when approximately 50% (~200 subjects) have been enrolled and completed the Treatment Phase 
of the study or early terminated, whichever comes first. The interim analysis will be directed and 
conducted by the DMC. The main purpose of this IA is to ensure the safety of the subjects in the 
trial and to recommend whether the trial should be stopped early to protect the safety of the 
participants. The DMC will review safety and efficacy data including the fraction of study 
participants who develop virologic failure and the fraction of those whose virus is successfully 
suppressed after re-initiation of oral combination antiviral therapy. However the decision to 
continue the trial will not be based on the efficacy analysis. The DMC will consist of at least three 
independent members (including clinicians with expertise in HIV disease, a neurologist or 
psychiatrist and at least one biostatistician) and will review all safety signals including number of 
virologic rebounds, unexpected AEs, all related AEs, all SAEs, and all deaths during the 
Treatment and Follow-Up Phases. 
All expedited safety reports will be provided in real time to the DMC chair upon being reported 
to FDA. The DMC will make the following recommendations at each safety evaluation: 
 
Continue the study as planned; 
 
Modify the study and continue; 
 
Terminate the study; 
 
Gather more data to address a specific safety issue and reconvene; 
 
Other (e.g., request changes to the protocol and propose sanctions). 
The Sponsor retains the responsibility to contact FDA and the final decision regarding the 
recommendation to continue or to terminate the study. 
A further description of the DMC reporting requirements, meeting frequency, and the study 
stopping/continuation criteria can be found in the DMC charter. 

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13 ETHICS AND REGULATORY REQUIREMENTS 
This study is to be conducted in accordance with the specifications of this protocol and in 
accordance with principles consistent with Declaration of Helsinki, GCP, 21 CFR Part 312, ICH 
E6, HIPAA regulations in 45 CFR Part 164 (US only), and the Belmont Principles of respect for 
persons, beneficence, and justice. No protocol changes will be implemented without the prior 
review and approval of the IRB, except when the modification does not involve the subject’s 
participation in the trial or where it may be necessary to eliminate an immediate hazard to a research 
subject. In the latter case, the change will be reported to the IRB as soon as possible, according to 
IRB regulations. 
Additionally, all study products used in this study are manufactured, handled and stored in 
accordance with applicable GMP and the products provided for this study will be used only in 
accordance with this protocol. 
 
13.1 INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) 
The Principal Investigator at the site will provide the Institutional Review Board/Independent 
Ethics Committee (IRB/IEC) with all appropriate materials as required by their IRB/IEC, including 
but not limited to the clinical study protocol, informed consent form, and any advertising materials. 
The study will not be initiated until the IRB/IEC provides written approval of the aforementioned 
documents and until approval documents have been obtained by the Principal Investigator and 
Sponsor or Sponsor designee. The Investigator will not participate in the decision. If the 
Investigator is an IRB or IEC member, documentation must be provided indicating recusal from 
the approval process. Appropriate reports on the progress of this study by the Principal Investigator 
will be made to the IRB/IEC as required by local and applicable government regulations and in 
agreement with policy established by the Sponsor. The Investigator is required to maintain an 
accurate and complete record of all written correspondence to and received from the IRB/IEC, and 
must agree to share all such documents and reports with the Sponsor. 
No changes from the final approved protocol will be initiated without the IRB/IEC’s prior written 
approval or favorable opinion of a written amendment, except when necessary to eliminate 
immediate hazards to the subjects or when the modification does not involve the subject’s 
participation in the trial. 
 
13.2 INVESTIGATOR’S RESPONSIBILITIES 
The Investigators are responsible for performing the study in full accordance with the protocol and 
the current revision of the Declaration of Helsinki, the Good Clinical Practice: Consolidated 
Guideline, approved by the ICH, and any applicable national and local laws and regulations. 

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Information regarding any study centers participating in this study that cannot comply with these 
standards will be documented. 
 
13.3 SUBJECT INFORMED CONSENT REQUIREMENTS 
Written and oral information about the study in a language understandable by the subject will be 
given to all subjects by the Investigator and/or designee. Written informed consent will be obtained 
from each subject before any procedures or assessments that would not otherwise be required for 
the care of the subject are done and after the aims, methods, anticipated benefits, potential hazards, 
and insurance arrangements in force are explained and the subject has been given sufficient time to 
ask questions and consider participation in the study. It will also be explained to the subjects that 
they are free to refuse entry into the study and free to withdraw from the study at any time without 
prejudice to future treatment. It is permissible for a third person (e.g., a family member) to be 
present during the explanation of the study. 
The written Informed Consent Form ICF is to be in compliance with CFR 21 Part 50.27 and GCP 
guidelines. The Sponsor and/or designated CRO will approve the ICF and all amendments to the 
ICF prior to submission to the IRB/IEC. A copy of the ICF to be used will be submitted by the 
Investigator to the IRB/IEC for review and approval prior to the start of the study. Each study site 
must provide the Sponsor with an unsigned copy of IRB/IEC-approved ICF along with applicable 
documentation to support this approval. The original signed ICF is retained in the subject's study 
records, and a copy is provided to the subject. A second copy may be filed in the subject’s medical 
record, if allowed by institutional policy. 

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14 DATA HANDLING AND RECORD KEEPING 
 
14.1 RECORDING AND COLLECTION OF DATA 
The primary source document for this study will be the subject's medical record. If separate research 
records are maintained by the Investigator(s), the medical record and the research records will be 
considered the source documents for the purposes of auditing the study. 
Applicable source data will be manually transcribed to the approved eCRFs. The Investigator is 
ultimately responsible for the accuracy of the data transcribed on the forms. All source documents 
and eCRFs will be completed as soon as possible after the subject's visit. 
The Investigator will review eCRFs to indicate that, to his/her knowledge, they are complete and 
accurate. Designated source documents will be signed and dated by the appropriate study personnel. 
The Investigator must agree to complete and maintain source documents and eCRFs for each 
subject participating in the study. 
All research data will be entered, either electronically or manually, into a computerized database. 
The clinical database will be designed by the clinical data manager in accordance with 21 CFR Part 
11 and based on protocol requirements defined by the Sponsor in association with the Lead 
Investigator. 
The Investigator will maintain a confidential list of study subjects that will include each subject’s 
study number, name, date of birth, and unique hospital identification number if applicable. This list 
will be kept by the Investigator and will not be collected by the Sponsor. A notation will be made 
in the subject’s case history/medical chart that he/she is participating in a clinical study and has 
provided a signed and dated ICF as well as a release for protected health information as required 
by local policies. The Investigator must also maintain a separate screening log of all the subjects 
screened for participation in the study; it should include gender, age, eligibility status, reason for 
ineligibility, if applicable; and study allocated subject number, if applicable. 
 
14.2 CLINICAL DATA MANAGEMENT 
The Sponsor and/or designated CRO will be responsible for the processing and quality control (QC) 
of the data. Data management will be carried out as described in the Sponsor’s or CRO’s standard 
operating procedures (SOPs) for clinical studies. 
The handling of data, including data QC, will comply with regulatory guidelines (e.g., ICH E6 
GCP, and local regulations where applicable) and the Sponsor’s or the CRO’s SOPs as well as 
provisions of the study-specific Data Management Plan. 
 
14.3 ARCHIVING 

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All study documentation at the Investigator site and Sponsor site will be archived in accordance 
with ICH GCP E6 and the Sponsor’s quality standards and SOPs. 
The Investigator will maintain all research records, reports, and case history reports for a period of 
two years after regulatory approval of the investigational product. If no application is filed or if the 
application is not approved, records must be maintained for two years after all investigations have 
been completed, terminated or discontinued and the FDA has been notified. 
These documents should be retained for a longer period however, if required by the applicable 
regulatory requirements or if needed by Sponsor or its authorized representative (as per 
GCP 5.5.11). 
At the completion of the study, details of the archival process must be provided to the Sponsor. 
Study records are subject to inspection by applicable health and regulatory agencies at any time. 
Records to be retained by the Investigator include, but are not restricted to: 
• Source data and the primary records upon which they are based (e.g., subject’s progress 
notes, adverse event data, test results, and any other diagnostic procedures required to 
evaluate the progress of the study) 
• Completed CRFs 
• Signed protocols and protocol amendments 
• Laboratory results, ranges, and certifications 
• Product (e.g., IP supplies) and accountability records 
• Study personnel signature log 
• Monitoring logs 
• Correspondence to and from the Sponsor, designee and IRB 
• Investigator and Sub-Investigator CVs 
• Signed informed consent and protected health information consent forms 
• Subject screening and enrollment log 
• SAE reports 
• IRB approval and re-approval letters 
• Other documents pertaining to the conduct of the study 
These documents must be maintained and kept on file by the Investigator so that the conduct of the 
study can be fully documented and monitored. 
At the completion of the study, details of the archival process must be provided to the Sponsor. 
Study records should not be transferred from site or destroyed without prior written agreement 
between the Sponsor and the study Investigator. 

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15 PUBLICATION PLAN 
All information supplied by CytoDyn in connection with this study and not previously published, 
is considered confidential information. This information includes, but is not limited to, the 
Investigator’s Brochure (IB), clinical protocol, case report forms and other scientific data. Any 
data collected during the study are also considered confidential. This confidential information 
shall remain the sole property of CytoDyn, shall not be disclosed to others without the written 
consent of CytoDyn, and shall not be used except in the performance of this study. 
It is understood by the Investigator that the Sponsor will use the information collected in this clinical 
trial in connection with the development of PRO 140. Therefore, this information may be disclosed 
as required to other Investigators or appropriate regulatory authorities. By agreeing to participate 
in this clinical trial, the Investigator understands that he/she has an obligation to provide the Sponsor 
with complete test results and all data developed during this trial. 
Publication and Disclosure: Because this is a multi-center trial, the site and Investigator shall not 
independently publish, publicly disclose, present or discuss any results of or information pertaining 
to the site’s and Investigator’s activities conducted under this protocol until such multi- center 
publication is released with the written approval and under the direction of Sponsor. 
Notwithstanding the foregoing, if a multi-center publication is not released within eighteen (18) 
months after completion of analysis of all study data from all studies conducted within the multi- 
center trial, both the site and Investigator shall have the right to publish the results of and 
information pertaining to the site’s and Investigator’s activities conducted under this protocol and 
the clinical trial agreement, subject to the prior review and written approval of Sponsor. The site 
and Investigator agree to submit any proposed manuscript, presentation or other public disclosure 
regarding the study to Sponsor for review at least thirty (30) days prior to submitting such proposed 
manuscript to a publisher or delivering or making such presentation or other public disclosure to 
any third party. Within thirty (30) days of its receipt, Sponsor shall advise the site and/or 
Investigator, as the case may be, in writing of any information contained therein that is confidential 
information (other than research results included in a proposed manuscript) or that may impair 
Sponsor’s ability to obtain patent protection. Sponsor shall have the right to require the site and/or 
Investigator, as applicable, to remove specifically identified confidential information (but may not 
require removal of research results from a proposed manuscript) and/or to delay the proposed 
submission or delivery of the proposed manuscript or presentation, or other public disclosure, for 
an additional sixty (60) days to enable Sponsor to seek patent protection. The site and Investigator 
shall not publish, publicly disclose, present or discuss any results of or information pertaining to 
the site’s and Investigator’s activities prior to completion of the trial, even if the multi-center trial 
or the study is terminated before its completion and the final clinical 

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study report is signed off, or with respect to any outcome measures or analyses other than those 
specified in this protocol. 

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16 REFERENCES 
Arribas JR, P. F.-G. (2005). Lopinavir/ritonavir as single-drug therapy for maintenance of HIV-1 
viral suppression: 48-week results of a randomized, controlled, open-label, proof-of-concept pilot 
clinical trial (OK Study). J Acquir Immune Defic Syndr. , 40, 280-287. 
Boffito M, B. D. (2003). Intra-individual variability in lopinavir plasma trough concentrations 
supports therapeutic drug monitoring. AIDS , 17, 1107-1108. 
Cahn P, M. J.-V.-M. (2011). Pilot, randomized study assessing safety, tolerability and efficacy of 
simplified LPV/r maintenance therapy in HIV patients on the 1st PI-based regimen. PLoS One. , 
6, e23726. 
Calza L, M. R. (2012). Protease inhibitor monotherapy as maintenance regimen in patients with 
HIV infection. Curr HIV Res. , 10, 661-72. 
Cameron DW, d. S. (2008). A 96-week comparison of lopinavir-ritonavir combination therapy 
followed by lopinavir-ritonavir monotherapy versus efavirenz combination therapy. Infect Dis. , 
198, 234-240. 
Demeter LM, S. R.-W. (2000). Delavirdine susceptibilities and associated reverse transcriptase 
mutations in human immunodeficiency virus type 1 isolates from patients in a phase I/II trial of 
delavirdine monotherapy (ACTG 260). Antimicrob.Agents Chemother. , 44, 794-797. 
Guiguet M, G. J., & CO4., F.-A. (2012). Boosted protease inhibitor monotherapy as a 
maintenance strategy: an observational study. AIDS , 26, 2345-50. 
Gutmann C, C. A. (2010). Randomized controlled study demonstrating failure of LPV/r 
monotherapy in HIV: the role of compartment and CD4-nadir. AIDS , 24, 2347-2354. 
Jacobson JM, L. J. (2010). study of the CCR5 monoclonal antibody PRO 140 administered 
intravenously to HIV-infected adults. Antimicrob Agents Chemother. , 54, 4137-42. 
Jacobson JM, S. M. (2008). Antiviral activity of single-dose PRO 140, a CCR5 monoclonal 
antibody, in HIV-infected adults. J Infect Dis. , 198, 1345-52. 
Jacobson JM, T. M. (2010). Anti-HIV-1 activity of weekly or biweekly treatment with 
subcutaneous PRO 140, a CCR5 monoclonal antibody. J Infect Dis. , 201, 1481-7. 
Katlama C, V. M.-G. (2010). Efficacy of darunavir/ritonavir maintenance monotherapy in 
patients with HIV-1 viral suppression: a randomized open-label, noninferiority trial MONOI- 
ANRS 136. AIDS , 24, 2365-2374. 
Marozsan, A. J. (2008). Clonal analysis of HIV-1 co-receptor tropism change following treatment 
with PRO 140, a CCR5 monoclonal antibody. 48th Annual ICAAC / IDSA 46th Annual Meeting, 
Abstract H-1218. Washington, DC. 
Meynard JL, B. V. (2010). Lopinavir/ritonavirmonotherapy versus current treatment continuation 
for maintenance therapy of HIV-1infection: the KALESOLO trial. J Antimicrob Chemother. , 65, 
2436-2444. 
Moltó J, S. J. (2007). Lopinavir/ritonavir monotherapy as a simplification strategy in routine 
clinical practice. J Antimicrob Chemother. (60), 436-439. 

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Nishikawa M, T. K. (2005). Analysis of binding sites for the new small-molecule CCR5 
antagonist TAK-220 on human CCR5. Antimicrob Agents Chemother , 49(11), 4708-4715. 
Nunes EP, S. d. (2009). Monotherapy with Lopinavir/Ritonavir as maintenance after HIV-1 viral 
suppression: results of a 96-week randomized, controlled, open-label, pilot trial (KalMo study). 
HIV Clin Trials. , 10, 368-374. 
Pulido F, A. J.-G.-E. (2008). Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and two 
nucleosides for maintenance therapy of HIV. AIDS , 22, F1-9. 
Richman, D. D. (1994). Nevirapine resistance mutations of human immunodeficiency virus type 1 
selected during therapy. J Virol. , 68, 1660-1666. 
Saag, M. S. (1993). A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of 
HIV-1 reverse transcriptase. N.Engl.J Med. , 329, 1065-1072. 
Simioni S, C. M. (2010). Cognitive dysfunction in HIV patients despite long-standing suppression 
of viremia. 24, 1243-1250. 
Spreen WR, M. D. (2013). Long-acting injectable antiretrovirals for HIV treatment and 
prevention. 8(6):565571. 
Thompson MA, A. J. (2012). Antiretroviral Treatment of Adult HIV Infection: 2012 
Recommendations of the International Antiviral Society–USA Panel. JAMA , 308, 387-402. 
Thompson, M. L. (2009). Weekly and bi-weekly subcutaneous PRO 140 demonstrates potent, 
sustained antiviral activity. 16th Conference on Retroviruses and Opportunistic Infections, 
Abstract #571a. Montreal QE, Canada,. 

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17 APPENDIX 
 
17.1 APPENDIX I: AIDS-DEFINING CONDITIONS 
• Bacterial infections, multiple or recurrent* 
• Candidiasis of bronchi, trachea, or lungs 
• Candidiasis of esophagus† 
• Cervical cancer, invasive§ 
• Coccidioidomycosis, disseminated or extrapulmonary 
• Cryptococcosis, extrapulmonary 
• Cryptosporidiosis, chronic intestinal (> 1 month's duration) 
• Cytomegalovirus disease (other than liver, spleen, or nodes), onset at age > 1 
month 
• Cytomegalovirus retinitis (with loss of vision)† 
• Encephalopathy, HIV related 
• Herpes simplex: chronic ulcers (> 1 month's duration) or bronchitis, 
pneumonitis, or esophagitis (onset at age > 1 month) 
• Histoplasmosis, disseminated or extrapulmonary 
• Isosporiasis, chronic intestinal (> 1 month's duration) 
• Kaposi sarcoma† 
• Lymphoid interstitial pneumonia or pulmonary lymphoid hyperplasia complex*† 
• Lymphoma, Burkitt (or equivalent term) 
• Lymphoma, immunoblastic (or equivalent term) 
• Lymphoma, primary, of brain 
• Mycobacterium avium complex or Mycobacterium kansasii, disseminated or 
extrapulmonary† 
• Mycobacterium tuberculosis of any site, pulmonary,†§ disseminated,† or 
extrapulmonary† 
• Mycobacterium, other species or unidentified species, disseminated† or 
extrapulmonary† 
• Pneumocystis jirovecii pneumonia† 
• Pneumonia, recurrent†§ 
• Progressive multifocal leukoencephalopathy 
• Salmonella septicemia, recurrent 
• Toxoplasmosis of brain, onset at age > 1 month† 

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• Wasting syndrome attributed to HIV 
 
* Only among children aged < 13 years. (CDC. 1994 Revised classification system for human immunodeficiency 
virus infection in children less than 13 years of age. MMWR 1994;43[No. RR-12].) 
† Condition that might be diagnosed presumptively. 
§ Only among adults and adolescents aged ≥ 13 years. (CDC. 1993 Revised classification system for HIV infection 
and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992;41[No. RR-17].) 
 
 
Source: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5710a2.htm 

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17.2 APPENDIX II: DIVISION OF AIDS TABLE FOR GRADING THE SEVERITY OF ADULT AND 
PEDIATRIC ADVERSE EVENTS (DAIDS AE GRADING TABLE) 
http://rsc.tech- 
res.com/Document/safetyandpharmacovigilance/DAIDS_AE_Grading_Table_v2_NOV2014.pdf 

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17.3 APPENDIX III: ADVERSE EVENTS OF SPECIAL INTEREST: INJECTION SITE REACTIONS 
The following table should be used to characterize injection-site reactions and provide appropriate 
grading of severity (DAIDS and modified additions). 
 
 
Injection-site Reactions 
Parameter 
Grade 1 (Mild) 
Grade 2 
(Moderate) 
Grade 3 (Severe) 
Grade 4 
(Potentially life- 
threatening) 
Injection-site pain 
Pain without 
touching or pain 
when area is 
touched: no or 
minimal limitation 
of use of limb 
Pain without 
touching or pain 
when area is 
touched limiting 
use of limb OR 
causing greater 
than minimal 
interference with 
usual social and 
functional 
activities 
Pain without 
touching or pain 
when area is 
touched causing 
inability to perform 
usual social and 
functional 
activities 
Pain without 
touching or pain 
when area is 
touched causing 
inability to perform 
basic self-care 
function OR 
hospitalization 
(other than 
emergency room 
visit) indicated for 
management of 
pain/tenderness 
Characterization of 
the injection site, if 
not normal 
Erythema OR 
induration of 5x5 
cm - 9x9 cm (or 25 
cm2-81 cm2) 
Erythema OR 
induration OR 
Edema > 9 cm any 
diameter (or > 81 
cm2) 
Ulceration OR 
secondary infection 
OR Phlebitis or 
Sterile abscess OR 
drainage 
Necrosis 
(involving dermis 
and deeper tissue) 
Pruritus associated 
with injection 
Itching localized to 
injection site AND 
relieved 
spontaneously or 
< 48 hours of 
treatment 
Itching beyond the 
injection site but 
not generalized OR 
itching localized to 
injection site 
requiring ≥ 48 
hours treatment 
Generalized itching 
causing inability to 
perform usual 
social and 
functional 
activities 
N/A 
Bleeding 
Initial bleed that 
does not exceed 
bandage and 
spontaneously 
stops 
Bleeding that 
exceeds bandage 
and spontaneously 
stops 
Continued bleeding 
that requires 
change of dressing 
and alternative 
injection site 
N/A 
Absorption of drug 
Minor elevation of 
skin at injection 
site but no leakage 
of injection 
material 
Leakage at 
injection site 
ceases with 
decrease in 
injection rate 
Leakage at 
injection site that 
does not cease with 
decrease in 
injection rate 

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17.4 APPENDIX V: NEUROLOGICAL ASSESSMENT 
 
Three Question Screening Survey (Simioni, et al, 2010) 
 
1. ‘Do you experience frequent memory loss (e.g. do you forget the occurrence of special 
events even the more recent ones, appointments, etc.)’? 
 
2. ‘Do you feel that you are slower when reasoning, planning activities, or solving problems’? 
 
3. ‘Do you have difficulties paying attention (e.g. to a conversation, a book, or a movie)’? 
 
For each question, subjects should provide one of the following answers: ‘never’, ‘hardly ever’, 
or ‘yes, definitely’. 
If subject answers “yes, definitely” to any question, additional neurological assessment 
modalities may be used as per Investigator’s discretion.