A Phase 3 Study of the Safety of Trogarzo® Administered as an Undiluted "IV Push" Over a Reduced Interval or as an Intramuscular Injection in Clinically Stable HIV-1 Infected Trogarzo® Experienced Patients and Healthy HIV-uninfected Volunteers
Phase: PHASE3
Conditions: HIV-1-infection
Sponsor: TaiMed Biologics Inc.

TAIMED BIOLOGICS, INC. 
CONFIDENTIAL 
PROTOCOL: TMB-302 
DATE: 09 JUNE 2022 
 
 
 
Use or disclosure of data contained on this page is subject  
to the restriction on the title page of this proposal or quotation. 
i 
 
 
 
 
 
STUDY PROTOCOL 
 
 
 
A Phase 3 Study of the Safety of Trogarzo® Administered as an Undiluted “IV Push” over a 
Reduced Interval or as an Intramuscular Injection in Clinically Stable HIV-1 Infected 
Trogarzo® Experienced Patients and Healthy HIV-uninfected Volunteers 
 
 
PROTOCOL NUMBER: TMB-302 - Amendment 6 
 
 
Version: 
7.0  
Date of Protocol: 
9 June 2022 
 
Sponsor: 
TaiMed Biologics, USA Corp. 
4790 Irvine Blvd.  
Suite 105-697 
Irvine, CA 92620 
 
 
 
 
 
 
 
 
 
 
 
 
 

TAIMED BIOLOGICS, INC. 
CONFIDENTIAL 
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Sponsor Contact: 
Brian Bell 
TaiMed Biologics, USA Corp. 
4790 Irvine Blvd.  
Suite 105-697 
Irvine, CA 92620 
Email: bbell@taimedbio.com 
 
Project Manager: 
 
Christine Anderson, PhD 
Westat 
1600 Research Blvd. 
Rockville, MD 20850 
Phone: 713-353-7911 
 
Medical Monitor: 
Martin Markowitz, MD 
TaiMed Biologics, USA Corp. 
4790 Irvine Blvd.  
Suite 105-697 
Irvine, CA 92620 
Email: mm5454@cumc.columbia.edu 
Study Principal 
Investigator: 
Edwin DeJesus, MD          
Orlando Immunology Center       
1707 N. Mills Ave                              
Orlando, FL  32803            
Phone:  407-647-3960 x2118        
Email:  edejesus@oicorlando.com         
Serious Adverse 
Event Reporting: 
 
Westat 
1600 Research Blvd. 
Rockville, MD 20850 
Phone: 888-464-5246 
Fax: 888-865-1983 
Email: regulatory@westat.com  
 
Proprietary Notice: 
This document contains mainly unpublished data and is the sole 
property of TaiMed Biologics, Inc. Therefore, it is provided to you in 
strict confidence as an investigator, potential investigator, or consultant. 
The information may be reviewed by you, your staff, and your 
institutional review board/independent ethics committee. It is 
understood that this information will not be disclosed to others without 
written authorization from TaiMed Biologics, Inc., except to the extent 
necessary to obtain informed consent from those persons to whom the 
drug may be administered. 
 
 

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Ethics Statement: 
The study will be completed according to the International Council for 
Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH) guidelines E6(R2): Good Clinical Practice: 
Consolidated Guideline and E2A: Clinical Safety Data Management. 
Compliance with this standard provides public assurance that the rights, 
safety, and well-being of trial subjects are protected, consistent with the 
principles that have their origin in the Declaration of Helsinki. The 
study will also follow the standards set forth in the Code of Federal 
Regulations Title 21 Parts 11 (Electronic Records), 50 (Protection of 
Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 
(Institutional Review Boards), and 312 (Investigational New Drug 
Application).  
 
 

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iv 
 
 
INVESTIGATOR’S STATEMENT 
 
I agree to conduct the study as outlined in the protocol entitled, “A Phase 3 Study of the Safety of 
Trogarzo® Administered as an Undiluted “IV Push” over a Reduced Interval or as an Intramuscular 
Injection in Clinically Stable HIV-1 Infected Trogarzo® Experienced Patients and Healthy HIV-
uninfected Volunteers” in accordance with the guidelines and all applicable government regulations. 
 
I have read and understand all sections of the protocol, including the section on administrative 
considerations (Section 11). 
 
 
______________________________ 
Investigator’s Name 
 
 
______________________________________________________________________________ 
Investigator’s Institution 
 
 
______________________________ 
___________________ 
Investigator’s Signature 
 
 
Date 
 
 
 

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v 
 
 
SPONSOR APPROVAL 
 
Approved by: 
 
 
 
 
 
 
______________________________________ 
_____________ 
Martin Markowitz, MD 
 
 
 
Date 
TaiMed Biologics, Inc. 
  
 
 
9 June 2022 

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PROTOCOL: TMB-302 
DATE: 09 JUNE 2022 
 
 
 
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TABLE OF CONTENTS 
 
STUDY PROTOCOL ............................................................................................................ i 
INVESTIGATOR’S STATEMENT ................................................................................. iv 
SPONSOR APPROVAL ...................................................................................................... v 
TABLE OF CONTENTS ................................................................................................... vi 
SYNOPSIS  ............................................................................................................................. x 
ABBREVIATIONS ............................................................................................................... 1 
1. Introduction ........................................................................................................................ 3 
1.1 
Background .......................................................................................... 3 
1.2 
Clinical Studies .................................................................................... 4 
1.3 
Pharmacokinetic and Pharmacodynamic Profile ............................ 9 
2. Study Objectives ............................................................................................................... 12 
2.1 
Primary Objectives ............................................................................ 12 
2.2 
Secondary Objectives ....................................................................... 13 
3. Study Plan .......................................................................................................................... 13 
3.1 
Overall Design ................................................................................... 13 
3.2 
Discussion of Trial Design .............................................................. 18 
3.3 
Dose Selection ................................................................................... 18 
3.4 
Schedule of Events ........................................................................... 18 
3.5 
Safety Assessments ........................................................................... 36 
3.6 
Pharmacokinetic Assessments ........................................................ 36 
4. Study Treatment ............................................................................................................... 37 
4.1 
Study Drug Dosage and Administration ....................................... 37 
4.2 
Prohibited Medications and Restrictions ....................................... 40 
4.3 
Safety Monitoring and Toxicity Management Plan ...................... 40 
4.4 
Study Stopping Rules ........................................................................ 45 
4.5 
Study Drug Description ................................................................... 45 
4.6 
Study Drug Accountability .............................................................. 46 
5. Subject Enrollment .......................................................................................................... 46 
5.1 
Inclusion Criteria ............................................................................... 47 
5.2 
Exclusion Criteria .............................................................................. 48 
5.3 
Subject Withdrawal and Discontinuation ...................................... 51 
5.3.1 
Reasons for Withdrawal or Discontinuation ................ 51 
5.3.2 
Handling of Withdrawals and Discontinuations .......... 52 
5.3.3 
Sponsor or Regulatory Agency Termination of 
Study ................................................................................... 53 
6. Study Visits ........................................................................................................................ 53 
6.1 
Sentinel Group .................................................................................. 54 
6.2 
Core Group ........................................................................................ 55 
6.3 
IM Group ........................................................................................... 57 

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6.4 
Follow-up Visits: Day 113 (Sentinel Group and HIV-
Uninfected IM Group) / Day 99 (Core and HIV-infected 
IM Groups) ........................................................................................ 59 
6.5 
Early Withdrawal Procedures .......................................................... 60 
6.6 
Unscheduled Visits ........................................................................... 60 
7. Study Assessments ........................................................................................................... 60 
7.1 
Activities to be Completed .............................................................. 61 
7.1.1 
Demographic Data, Medical History, and 
Concomitant Medications ............................................... 61 
7.1.2 
Complete Physical Examination ..................................... 61 
7.1.3 
Targeted Physical Examination ...................................... 61 
7.1.4 
Vital Sign Measurements ................................................. 61 
7.1.5 
 Patient Reported Outcomes........................................... 61 
7.2 
Blood and Urine Samples ................................................................ 62 
7.2.1 
Clinical Laboratory Parameters....................................... 62 
7.2.2 
Archive Sample ................................................................. 63 
7.2.3 
HIV-1 Viral Resistance Testing ...................................... 63 
7.2.4 
HIV-1 RNA Level ............................................................ 64 
7.2.5 
CD4+ Cell Count .............................................................. 64 
7.2.6 
Immunogenicity of Trogarzo® ........................................ 64 
7.2.7 
Trogarzo® Serum Concentrations .................................. 64 
7.2.8 
Serum Follicle-Stimulating Hormone Testing .............. 64 
7.2.9 
Pregnancy Testing ............................................................ 65 
7.2.10 
4th Generation Point of Care HIV-1 Testing ................ 65 
7.2.11 
Hepatitis B Surface Antigen and Hepatitis C 
Antibody Testing .............................................................. 65 
8. Adverse Events ................................................................................................................. 65 
8.1 
Definitions ......................................................................................... 65 
8.2 
Eliciting Adverse Event Information............................................. 66 
8.3 
Reporting Adverse Events ............................................................... 67 
8.4 
Assessment of Causality ................................................................... 68 
8.5 
Assessment of Severity ..................................................................... 69 
8.6 
Serious Adverse Event Reporting .................................................. 71 
8.7 
Pregnancy ........................................................................................... 73 
8.8 
Data Monitoring Committee ........................................................... 75 
9. Statistical Considerations ................................................................................................ 76 
9.1 
General Methodology ....................................................................... 76 
9.2 
Populations for Analysis .................................................................. 76 
9.2.1 
Intent-to-Treat Population .............................................. 76 
9.2.2 
Safety Population .............................................................. 76 
9.3 
Subject Disposition ........................................................................... 76 
9.4 
Demographics and Baseline Characteristics.................................. 77 
9.5 
Safety Analyses .................................................................................. 77 
9.5.1 
Adverse Events ................................................................. 77 
9.5.2 
Clinical Safety Laboratory Parameters ........................... 77 

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9.6 
Efficacy ............................................................................................... 78 
9.7 
Pharmacokinetic Analyses ............................................................... 78 
9.8 
Sample Size and Power Considerations ......................................... 79 
10. Data Handling and Quality Assurance ........................................................................ 79 
10.1 
Electronic Case Report Forms ........................................................ 79 
10.2 
Monitoring of the Study ................................................................... 80 
10.3 
Inspection of Records ...................................................................... 81 
10.4 
Study Record Retention ................................................................... 81 
11. Administrative Considerations ..................................................................................... 81 
11.1 
Confidentiality ................................................................................... 81 
11.2 
Institutional Review Board or Independent Ethics 
Committee Approval ........................................................................ 82 
11.3 
Modification of the Protocol ........................................................... 82 
11.4 
Informed Consent ............................................................................. 82 
11.5 
Protocol Violations and Deviations ............................................... 83 
11.6 
Study Reporting Requirements ....................................................... 84 
11.7 
Financial Disclosure and Obligations ............................................ 84 
11.8 
Investigator Documentation ........................................................... 85 
11.9 
Study Conduct ................................................................................... 86 
11.10 Publications ........................................................................................ 86 
References  ........................................................................................................................... 87 
 
 
 
Tables 
 
Table 1 
Schedule of Events – Sentinel Group (Subjects 1-5) ........................... 20 
Table 2 
Schedule of Events – HIV-uninfected Core and IM Groups Only 
(Subjects 6-40): Screening and Pre-Steady State Phase: Day -83 to Day 
-13 ......................................................................................................... 26 
Table 3 
Schedule of Events – HIV-infected Core Group (Subjects 6-20) and 
HIV-uninfected Core Group (Subjects 6-20; Days 1-99) ..................... 28 
Table 4 
Schedule of Events for IM Group (HIV-Infected and HIV-Uninfected 
Subjects) .............................................................................................. 34 
 
Appendices 
Appendices to this protocol are presented in a separate document entitled: 
“Appendices to Protocol TMB-302: A Phase 3 Study of the Safety of Trogarzo® Administered as an 
Undiluted “IV Push” over a Reduced Interval or as an Intramuscular Injection in Clinically Stable 
HIV-1 Infected Trogarzo® Experienced Patients and Healthy HIV-uninfected Volunteers” 
 
The Appendices include the following: 
Appendix A: CDC AIDS Defining Conditions 

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Appendix B: Division of AIDS: Table for Grading the Severity of Adult and Pediatric 
Adverse Events Version 2.1 (July 2017) 
Appendix C: “The diagnosis and management of anaphylaxis: An updated practice 
parameter” 
Appendix D: HIV Treatment Satisfaction Questionnaires (HIVTSQs, HIVTSQc) and 
Study Medication Satisfaction Questionnaires (SMSQs, SMSQc) 

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PROTOCOL: TMB-302 
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SYNOPSIS 
Protocol Number: 
TMB-302 
Title: 
A Phase 3 Study of the Safety of Trogarzo® Administered as an 
Undiluted “IV Push” over a Reduced Interval or as an Intramuscular 
Injection in Clinically Stable HIV-1 Infected Trogarzo® 
Experienced Patients and Healthy HIV-uninfected Volunteers 
Sponsor: 
TaiMed Biologics, USA Corp. 
4790 Irvine Blvd.  
Suite 105-697 
Irvine, CA 92620 
Study Phase: 
3 
Subjects and 
Investigator Sites:  
A total of approximately 40 subjects will be enrolled into this study.  
Approximately twenty (20) will receive Trogarzo® as an 
intravenous (IV) push and approximately 20 subjects will receive 
Trogarzo® as an intramuscular (IM) injection at approximately 7-8 
sites in the United States.  Subjects who receive Trogarzo® as an IV 
Push can also receive Trogarzo® as an IM injection once they 
complete the IV push portion of study.  After 20 subjects enroll to 
complete the IV push portion of the study, subjects who enroll may 
participate in the IM portion exclusively. 
Study Drug Dosage 
and Route of 
Administration: 
The study drug, Trogarzo®, is a humanized IgG4 monoclonal 
antibody (MAb) approved for use in treatment-experienced subjects 
in combination with other antiretroviral agents for the treatment of 
multi-drug resistant HIV-1 infection and is administered via 
intravenous infusion (IV).  
Maintenance doses of 800 mg Trogarzo® will be administered to all 
study subjects every 2 weeks throughout their participation in the 
study.  
For subjects receiving Trogarzo® as an IV push, the Day1/Baseline 
and Day 15 doses will be administered as diluted intravenous 
infusions (IVI - 800 mg in 250 mL normal saline; 3.2 mg/mL) over 
15 minutes in accordance with Trogarzo® prescribing information. 
Subsequent Trogarzo® doses on study will be administered at 
increased concentration over a shorter interval (<15 minutes – see 
Study Design for more detail). 
For subjects receiving Trogarzo® via IM injection, the 
Day 1/Baseline and Day 15 doses will be administered as diluted 
IVI over 15 minutes in accordance with Trogarzo® prescribing 
information.  The subsequent four (4) Trogarzo® doses on study 
will be administered as an IM injection. 

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All subjects will continue on all other antiretroviral (ARV) 
medications as prescribed by the primary care provider throughout 
study participation. Any changes in ARV treatment will be recorded 
with reasons for treatment modification. All HIV-infected subjects 
will return to routine Trogarzo® administration via IVI over 
15 minutes in accordance with the prescribing information after 
completing participation in the study. 
 
Control Drug, Dosage, 
and Route of 
Administration: 
None  
Objectives: 
 
The primary objective of this study is to: 
◼ 
Evaluate the safety of Trogarzo® administered as an 
undiluted “IV push” over 30 seconds or as an IM injection in 
clinically-stable HIV-1 infected subjects with at least 
3 months of stable treatment with a Trogarzo®-containing 
ARV regimen or healthy HIV-uninfected volunteers 
◼ 
Compare the AUC and trough serum drug concentration after 
IVI with the diluted drug to the AUC and trough serum 
concentration after IV push of undiluted Trogarzo® 
◼ 
Compare the trough serum drug concentration after IVI with 
the diluted drug to the trough serum concentration after IM 
injection of undiluted Trogarzo®. 
The secondary objectives of this study are to: 
◼ 
Assess HIV-1 viral load for IVI compared to IV push and IM 
injection in HIV-1 infected subjects only  
◼ 
Characterize noted human immunodeficiency virus type-1 
(HIV-1) sensitivity/susceptibility changes in participants with 
an increase in plasma viral load to levels above 
1,000 copies/mL on 2 consecutive measurements at least 
2 weeks apart in HIV-1 infected subjects only 
◼ 
Determine the presence and significance of anti-Trogarzo® 
antibodies, if any (immunogenicity of Trogarzo®)  
◼ 
Compare the AUC after IVI with the diluted drug to the AUC 
after IM injection of undiluted Trogarzo® 
Subject Population: 
Inclusion Criteria 
 
HIV-1 infected individuals: 
Subjects must meet all of the following criteria to be included in the 
study: 
1. Are capable of understanding and have voluntarily signed the 
informed consent document 
2. Currently receiving a stable Trogarzo®-containing ARV 
regimen for a minimum of 3 months, and no change in 

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background ARVs anticipated over the period of study 
participation; a stable regimen is defined as having no changes 
in dose or frequency and no interruptions ≥2 weeks during the 
3-month period 
Note: For subjects who receive Trogarzo® as an IV push (Core 
Group) and subsequently enter the study to receive Trogarzo® 
as an IM injection (IM Group), the time period while receiving 
the IV push will be considered as having received a stable 
Trogarzo®-containing ARV regimen.  
Note: HIV-infected subjects who are enrolled in the IM 
injection study and are unable to adhere to the study schedule 
for IM dosing due to factors outside the study will be 
discontinued. Re-enrollment of HIV-infected IM Group 
subjects will be allowed after a Discontinuation Visit and 
Screening Visit are completed provided that inclusion/exclusion 
criteria continue to be satisfied and dosing after discontinuation 
is resumed according to the Trogarzo® Prescribing Information.  
For re-enrolling subjects, the inclusion criteria for stable a 
Trogarzo®-containing ARV regimen is satisfied with a loading 
dose of 2000mg IVI and at least one maintenance dose of 
800mg IVI given according to Trogarzo® labeling prior to Day 
1 enrollment. 
3. Have no acquired immunodeficiency syndrome (AIDS)-
defining events in the 3 months before Screening, other than 
cutaneous Kaposi’s sarcoma or wasting syndrome due to HIV 
4. Are able and willing to comply with all protocol requirements 
and procedures 
5. Are 18 years of age or older 
6. Have a life expectancy that is >6 months. 
7. Have a viral load <1,000 copies/mL at Screening 
8. CD4+ T-cell count >50 cells/mm3 at Screening 
9. Prothrombin time (PT) and partial thromboplastin time (PTT) 
<1.5 times the upper limit of normal value (for IM Group only) 
HIV-uninfected individuals: 
Subjects must meet all of the following criteria to be included in the 
study:  
1. Healthy volunteers born male and female as assessed by medical 
history and physical examination 

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2. Aged >18 and <50 years at the time of Screening 
3. Ability and willingness to provide written informed consent 
4. Willingness to comply with protocol schedule 
5. Willingness to undergo HIV-1 testing 
6. Non-reactive 4th generation point of care HIV-1 test at Screening 
7. Hepatitis B Surface antigen negative 
8. Hepatitis C antibody negative, or if reactive, Hepatitis C RNA 
undetectable in plasma 
9. PT and PTT <1.5 times the upper limit of normal (for IM Group 
only) 
10. Volunteers born female of reproductive potential who are 
sexually active with a male sex partner must agree to use one 
effective method of contraception from the time of signing the 
consent to completion of the study and agree to pregnancy testing 
as per the schedule of events.  
Volunteers born female with reproductive potential are defined 
as pre-menopausal volunteers born female who have not had a 
sterilization procedure (e.g., hysterectomy, bilateral 
oophorectomy, tubal ligation or salpingectomy).  Volunteers 
born female are considered menopausal if they have not had a 
menses for at least 12 months and have a follicle-stimulating 
hormone (FSH) of greater than 40 IU/L or if FSH testing is not 
available, they have had amenorrhea for 24 consecutive months. 
Subject Population: 
Exclusion Criteria 
 
HIV-infected participants: 
Subjects having or meeting any of the following conditions or 
characteristics will be excluded from the study: 
1. Any active AIDS-defining illness according to the Centers for 
Disease Control and Prevention (CDC) Revised Surveillance 
Case Definitions for HIV Infection 2008 (MMWR Vol.57/No. 
RR-10), or history of the same during the 3 months preceding 
Screening, with the following exceptions: cutaneous Kaposi's 
sarcoma and wasting syndrome due to HIV  
2. Any significant diseases (other than HIV-1 infection) or 
clinically significant findings, including psychiatric and 
behavioral problems, determined from Screening, medical 
history, and/or physical examination that, in the investigator’s 
opinion, would preclude the subject from participating in this 
study 

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3. Any significant acute illness within 1 week before the initial 
administration of study drug 
4. Any active infection secondary to HIV requiring acute therapy; 
however, subjects that require maintenance therapy (i.e., 
secondary prophylaxis for opportunistic infections) will be 
eligible for the study. 
5. Any immunomodulating therapy (including interferon), 
systemic steroids, or systemic chemotherapy within 12 weeks 
before Enrollment 
6. Any vaccination within 7 days before Day 1 
7. Any female subject who either is pregnant, intends to become 
pregnant, or is currently breastfeeding 
8. Any current alcohol or illicit drug use that, in the investigator’s 
opinion, will interfere with the subject’s ability to comply with 
the study schedule and protocol evaluations 
9. Any radiation therapy during the 28 days before first 
administration of study medication 
10. Any Grade 3 or 4 laboratory abnormality according to the 
Division of AIDS grading scale, except for the following 
asymptomatic Grade 3 events: 
➢ Triglyceride elevation 
➢ Total cholesterol elevation 
➢ Grade 3 or 4 reductions in levels of CD4+ T cells 
 
11. History of coagulopathy that would preclude administration of 
IM injections (IM Group only) 
12. Skin rashes or tattoos that would prevent ability to assess IM 
injection-site reactions (IM Group only) 
13. Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, 
dipyridamole or other antiplatelet medication that would 
interfere with the ability to receive IM injections (IM Group 
only) 
 
HIV-uninfected individuals 
1. Confirmed HIV-1 infection at screening 
2. At high risk of severe COVID-19 disease as defined by one of 
the following: 
➢ History of hypertension, atherosclerotic cardiovascular 
disease (ASCVD), coronary artery disease, diabetes mellitus  

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➢ History of asthma or chronic pulmonary disease 
➢ History of renal disease and chronic renal insufficiency 
➢ Body mass index (BMI) over 35 
3. Any acute or chronic medical condition that in the opinion of 
the investigator would preclude participation 
4. Chronic autoimmune disease 
5. Active IV drug use 
6. Excessive use of alcohol or recreational drugs that in the 
opinion of the investigator would preclude participation. 
7. Decompensated psychiatric illness 
8. Need for chronic immunotherapy including systemic 
corticosteroids, other monoclonal antibody (MAb) therapy, or 
immunosuppressive drugs 
9. Volunteers born female who are pregnant, lactating, or planning 
on becoming pregnant over the study period 
10. Any of the following laboratory parameters: 
➢ Hemoglobin <10.0 g/dL 
➢ Absolute neutrophil count <1,000/mm3 
➢ Absolute lymphocyte count <500/mm3 
➢ Platelet count <100,000/mm3 
➢ Creatinine >1.25x upper limit of normal (ULN) 
➢ Aspartate aminotransferase (AST) >1.5 x ULN 
➢ Alanine aminotransferase (ALT) >1.5 x ULN 
➢ Glucose (non-fasting) >160 mg/dL 
➢ Proteinuria: 2+ or greater 
➢ Hematuria: >10 red blood cells (RBCs) per high-power field 
11. Previous receipt of an experimental mAb to HIV-1 in a research 
study 
12. History of severe allergic reactions to drugs, vaccines, or drug 
infusion 
13. Participation in another investigational clinical trial within the 
past 12 weeks or anticipated during the course of the current 
study 
14. History of coagulopathy that would preclude administration of 
IM injections (IM Group only) 
15. Skin rashes or tattoos that would prevent ability to assess IM 
injection-site reactions (IM Group only) 

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16. Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, 
dipyridamole or other antiplatelet medication that would 
interfere with the ability to receive IM injections (IM Group 
only) 
Study Design: 
 
This Phase 3 study will evaluate the safety and serum 
concentrations of Trogarzo® administered in progressively 
increasing concentrations over shortening intervals with the goal of 
administration of an undiluted IV push over an interval of 
30 seconds in clinically stable subjects currently receiving treatment 
with a stable Trogarzo®-containing regimen for a minimum of 3 
months or healthy HIV-uninfected volunteers.  The study will also 
evaluate an IM administration of Trogarzo®. 
The first five (5) subjects enrolled will comprise the Sentinel 
Group. Subjects six (6) through twenty (20) comprising the Core 
Group will not be screened until the Sentinel Group has completed 
Day 99 (14 weeks) of the study and the DMC has reviewed 
accumulated data and given approval for the study to continue. 
The IM Group will comprise twenty (20) subjects receiving 
Trogarzo® as an IM injection.  Subjects completing the IV push 
portion of the study (from the Sentinel and Core Groups) are 
eligible to participate in the IM Group. 
Sentinel Group (Subjects 1 to 5) 
Subjects in the Sentinel Group will receive an 800 mg maintenance 
dose of Trogarzo® in accordance with the prescribing information 
(diluted in 250 mL normal saline and administered over 15 minutes 
via IVI) at Day 1/Baseline and again at Day 15.  Every two weeks 
thereafter through Day 85 (12 weeks), subsequent maintenance 
doses will be administered at successively increasing concentrations 
via IVI, IV bolus, and concluding with IV push over successively 
shorter intervals according to the following schedule: 
◼ 
Day 1/Baseline and Day 15: 800 mg diluted in 250 mL 
normal saline (at 3.2 mg/mL) via IVI over 15 minutes per 
approved Trogarzo® prescribing information 
◼ 
Day 29 (4 weeks): 800 mg diluted in 50 mL normal saline (at 
16 mg/mL) via IVI over 10 minutes 
◼ 
Day 43 (6 weeks): 800 mg diluted in 16 mL normal saline (at 
50 mg/mL) via IV bolus over 5 minutes 
◼ 
Day 57 (8 weeks): 800 mg diluted in 8 mL normal saline (at 
100 mg/mL) via IV bolus over 1 minute 

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◼ 
Day 71 (10 weeks): 800 mg undiluted (at 150 mg/mL) via IV 
push over 30 seconds 
◼ 
Day 85 (12 weeks): 800 mg undiluted (at 150 mg/mL) via IV 
push over 30 seconds 
For the End of Study (EOS) visit at Day 99 (14 weeks), Sentinel 
Group subjects will revert to diluted IVI dosing over 15 minutes in 
accordance with the Trogarzo® prescribing information. 
Enrollment into the Sentinel Group will be staggered, and a DMC 
will review available data at scheduled intervals and upon the 
occurrence of identified safety events throughout the study (see 
Section 4.3).  When five (5) subjects in the Sentinel Group have 
completed Day 99 (14 weeks) of the study, the DMC will review 
the available data to determine whether the study should proceed to 
enrollment of the Core Group.  
Core Group (Subjects 6 to 20) 
HIV-1 infected individuals: 
After DMC review and approval, the Core Group (subject numbers 
six [6] through twenty [20]) will be enrolled.  Subjects in the Core 
Group will also receive an 800 mg maintenance dose of Trogarzo® 
in accordance with the prescribing information (diluted in 250 mL 
normal saline and administered over 15 minutes via IVI) at 
Day 1/Baseline and again at Day 15.  Every 2 weeks thereafter 
through Day 71 (10 weeks), subsequent maintenance doses will be 
administered via undiluted IV push over 30 seconds.  At Day 85 
(12 weeks), Core Group subjects will revert to diluted IVI dosing 
over 15 minutes in accordance with the Trogarzo® prescribing 
information. 
HIV-uninfected individuals: 
Pre-steady State Phase: Subjects will receive a 2000 mg infusion 
over 60 minutes on Day -55 followed by 3 doses of 800 mg infusion 
over 15 minutes on Days -41, -27, and -13.  On Day 1 the subjects 
will enter the Treatment Study Phase. 
Treatment Study Phase:  These HIV-uninfected subjects will 
receive an 800 mg dose of Trogarzo® in accordance with the 
prescribing information (diluted in 250 mL normal saline and 
administered over 15 minutes via IVI) at Day 1/Baseline and again 
at Day 15.  Every 2 weeks thereafter through Day 71 (10 weeks), 
subsequent doses will be administered via undiluted IV push over 
30 seconds.  After the Day 71 administration, HIV-uninfected Core 
Group subjects will discontinue Trogarzo® therapy.  

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IM Group 
The IM Group will enroll either subjects who were enrolled and 
completed the study from the Sentinel and Core groups or other 
subjects new to the study who were not previously involved in the 
IV push portions.  Subjects for inclusion in the IM Group will be 
recruited only once all subjects for the Core Group have been 
enrolled in and completed the Core study. 
HIV-1 infected individuals: 
Subjects will receive the first two doses of study drug in accordance 
with the Trogarzo® prescribing information (diluted in normal 
saline and administered over 15 minutes via IVI) at Day 1/Baseline 
and again at Day 15.  The next four doses of Trogarzo® through 
Day 71 (10 weeks) will be administered as an IM injection.  At 
Day 85 (12 weeks), IM Group subjects will revert to diluted IVI 
dosing over 15 minutes in accordance with the Trogarzo® 
prescribing information. 
For re-enrolling subjects, a loading dose of 2000mg IVI and at least 
one maintenance dose of 800mg IVI will be given according to the  
label to re-establish study eligibility from a Trogarzo® dosing 
perspective starting at least 4 weeks prior to Day 1.  The day of the 
2000mg loading dose may also serve as the Discontinuation or Re-
screening visit, as appropriate for subject and study site scheduling 
needs for re-enrolling subjects. 
HIV-uninfected individuals: 
Pre-Steady State Phase: Subjects will receive four doses of 
Trogarzo® as described above for Core Group HIV-uninfected 
individuals prior to the Study Treatment Phase. 
Study Treatment Phase:  HIV-uninfected subjects in the IM Group 
will receive the first two doses of Trogarzo® in accordance with the 
prescribing information (diluted in 250 mL normal saline and 
administered over 15 minutes via IVI) at Day 1/Baseline and again 
at Day 15.  The next four doses of Trogarzo® will be administered 
as an IM injection.  HIV-uninfected subjects will discontinue dosing 
after the Day 71 study drug administration.  
A total volume of 5.32 mL, corresponding to 800 mg Trogarzo, will 
be injected intramuscularly and will be split into two injections of 
approximately 2.66 mL each.  The two IM injections should be 
administered in the muscle tissue of the subject’s anterolateral 
aspect of the thighs (left, right, or both) or, alternatively, in the 

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dorsogluteal site (upper outer quadrant of the buttock).  In either 
area, injections sites should be at least 1 inch apart. 
All Groups: 
After each study drug administration, all HIV-infected study 
subjects in both groups will be observed for at least 15 minutes, and 
HIV-uninfected subjects will be observed for at least 60 minutes for 
acute injection-related reactions.  Injection-site reactions will also 
be monitored during subsequent study visits.  All AEs will be 
recorded.  Vital signs will be measured and recorded at the 
beginning and end of this observation period. 
Clinical site personnel and emergency medications and equipment 
will be available to manage any infusion or injection reactions as 
medically indicated.  Hypersensitivity reactions including infusion-
related reactions and anaphylactic reactions have been reported 
following infusion of ibalizumab during post-approval use.  
Subjects should be monitored closely for such symptoms during 
observation. 
Injection site reactions will be assessed in subjects who receive IM 
injections of Trogarzo® at each visit during IM administration and 
follow-up. 
Subjects will be followed for safety through 28 days after the last 
administration of Trogarzo® on study (from Day 85 [12 weeks] 
through Day 113 [16 weeks] for the Sentinel and HIV-infected IM 
Groups, from Day 71 [10 weeks] through Day 99 [14 weeks] for the 
HIV-uninfected Core and IM Groups, and at Day 99 for the 
HIV-infected Core Group). 
Safety Assessments: 
Safety assessments will include results of the following 
measurements through Day 99 (14 weeks) for the Sentinel Group, 
Day 85 (12 weeks) for the HIV-1 infected Core Group and IM 
Group subjects, and Day 99 (14 weeks) for the HIV-uninfected 
healthy volunteers in the Core Group and IM Group: 
 
◼ 
Physical examinations 
◼ 
Vital sign measurements 
◼ 
Clinical laboratory parameters (hematology, serum 
chemistry, urinalysis and CD4+ T-cell count) 
◼ 
Monitoring of AEs and concomitant medications 
◼ 
Anti-Trogarzo® antibody levels (immunogenicity of 
Trogarzo®)  
 

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Laboratory samples will be collected every 2 weeks, at visits where 
Trogarzo® is administered.  Beginning at Day 29 (4 weeks), 
non-laboratory safety assessments will be performed weekly 
through Day 99 (14 weeks) for the Sentinel Group, through Day 85 
(12 weeks) for the HIV-1 infected Core Group and IM Group, and 
Day 99 (14 weeks) for the HIV-uninfected Core Group and IM 
Group. 
Statistical 
Considerations: 
Sample Size: A sample size of approximately 40  subjects will be 
enrolled including approximately 20 subjects who will receive 
Trogarzo® as an IV push and approximately 20 subjects who will 
receive Trogarzo® as an IM injection.  Subjects who have 
previously received Trogarzo® as an IV push are permitted to 
screen/enroll for participation in the IM Group.   
The safety and PK analysis will include all subjects.  Intra-subject 
AUC and serum trough concentrations of study drug after IV 
infusion will be compared with concentrations following both IV 
push and IM injection.  
The analysis of study data will be primarily descriptive, with 
emphasis on tabular and graphical displays. Summary descriptive 
statistics will be calculated along with point and interval estimates 
of AEs. 
Analysis Sets: A Safety (SAF) and an Intent-to-Treat (ITT) 
analysis dataset will be created.  The SAF will include all subjects 
receiving at least one partial dose of study drug and ITT is all 
subjects enrolled into the study.  The SAF Analysis Set will be used 
for the primary safety analysis.  The ITT Analysis Set will be used 
for the AUC and trough serum drug concentration and the 
secondary effectiveness analysis.  
Safety Analyses: The safety analyses will include descriptions of 
treatment-emergent AEs, Class C events per the CDC Classification 
System for HIV Infection, clinical laboratory test results, physical 
examination findings, vital sign results, and immunogenicity of 
Trogarzo®. 
Data collected at each visit will be summarized where applicable. 
Continuous variables (e.g., age, weight) will be summarized using 
descriptive statistics consisting of number of subjects, mean, 
standard deviation (SD), and minimum, median, and maximum 
values . Categorical variables will be summarized using the number 
and percentage of subjects in each category.   
Pharmacokinetic Analysis: The exposure-response relationship 
established for the review of the ibalizumab Biologics License 
Application (BLA) was based on Ctrough, rather than AUC.  Ctrough 

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was used as an indicator of exposure and a clear trend between 
exposure and the efficacy endpoint was observed.  Therefore, Ctrough 
is more representative of efficacy for this pharmacokinetic bridging 
study than AUC.  A PK bridge between the IV push and IVI and 
between the IM injection and IVI is demonstrated if the proportions 
of subjects with average Ctrough equal to or exceeding the threshold 
of 300 ng/mL are comparable using a Fisher’s Exact test.  A PK 
bridge is also demonstrated for AUC if the 90% confidence interval 
of log transform of the ratio of the geometric means for IV push or 
IM injection (test product) to IVI (reference product) for the 
40 subjects in the study is within an 80%-125% criteria.  
Secondary Endpoint Analysis:  Assessment of the HIV-1 viral 
load measurements will be made as a secondary endpoint in 
HIV infected subjects by comparing the mean viral load at visits 
when subjects received an IV infusion to the visits when receiving 
an IV push over 30 seconds or receiving IM injections. 
 
HIV-infected study subjects will be considered virologic failures if: 
 
1. Viremic subjects experience a sustained >0.5 log increase in 
plasma HIV-1 RNA from baseline  
or 
2. A sustained VL>200 copies/mL if subject VL was 
<50 copies/mL at baseline  
 
that cannot be explained by intercurrent illness, a change in 
adherence to the background regimen, or unanticipated changes to 
the background regimen will meet the definition of virologic failure. 
Sustained is defined as 2 consecutive viral load determinations at 
least 2 weeks apart. 
 
Exploratory statistical analyses will examine any noted changes in 
HIV-1 drug sensitivity/susceptibility in participants with an increase 
in plasma viral load to levels above 1,000 copies/mL on 2 
consecutive measurements at least 2 weeks apart. 
Pharmacokinetics 
(PK)  
PK Analysis: PK samples will be collected during the study as 
shown in the Schedule of Events.  These samples will be collected 
from subjects at selected times to evaluate PK parameters. 

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ABBREVIATIONS 
 
ABBREVIATION 
TERM 
AE 
adverse event 
AIDS 
acquired immunodeficiency syndrome 
ALT 
alanine aminotransferase  
ART 
antiretroviral therapy 
ARV 
Antiretroviral 
ASCVD 
Atherosclerotic cardiovascular disease 
AST 
aspartate aminotransferase  
AUC 
area under the curve 
BLA 
Biologics License Application 
BMI 
body mass index 
CD4 
cluster of differentiation 4 (glycoprotein expressed on the surface of T-
helper cells) 
CD4+ 
cluster of differentiation 4 positive (type of white blood cell, also called T-
lymphocytes, T-cells, or T-helper cells) 
CDC 
Centers for Disease Control and Prevention 
CFR 
Code of Federal Regulations 
CL 
Clearance 
Cpeak 
Peak concentration 
CRF 
Case Report Form 
CSR 
clinical study report 
CT 
Computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
Ctrough 
Trough concentration 
DAIDS 
Division of AIDS 
DLT 
dose-limiting toxicity 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
EDC 
electronic data capture 
ELISA 
enzyme linked immunosorbent assay 
EOS 
end of study 
FDA 
U.S. Food and Drug Administration 
FSH 
follicle-stimulating hormone 
HIV 
human immunodeficiency virus 
HIV-1 
human immunodeficiency virus type-1 
HIVTSQ 
HIV Treatment Satisfaction Questionnaire 
HTE 
heavily treatment experienced 
ICH 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use 
ID 
Identification 
IgG4 
immunoglobulin 4 
IM 
Intramuscular 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ITT 
intent-to-treat 
IV 
Intravenous 
IVI 
intravenous infusion 

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ABBREVIATION 
TERM 
IVP 
intravenous push 
LLOQ 
lower limit of quantitation 
MAb 
monoclonal antibody 
MedDRA 
Medical Dictionary for Regulatory Activities  
MEF 
missing equals failure 
MMWR 
Morbidity and Mortality Weekly Report 
Mu5A8 
murine progenitor of Trogarzo® 
NAAT 
Nucleic acid amplification 
OBR 
optimized background regimen 
PD 
pharmacodynamic(s) 
PK 
pharmacokinetic(s) 
PML 
Progressive multifocal leukoencephalopathy 
POC 
Point of Care 
PT 
Prothrombin Time 
PTT 
Partial Thromboplastin Time 
q2wk 
every 2 weeks 
q4wk 
every 4 weeks 
QoL 
Quality of Life 
qwk 
once a week 
RA 
regulatory affairs 
RBC 
Red blood cell 
RNA 
ribonucleic acid 
SAE 
serious adverse event 
SAF 
safety dataset for analysis 
SC 
Subcutaneous 
SD 
Standard Deviation 
SMSQc 
Study Medication Satisfaction Questionnaire change version 
SOC 
System Organ Class 
TEAE 
treatment-emergent adverse event 
TFDA 
Taiwan Food and Drug Administration 
Tmax 
time to maximum concentration 
ULN 
upper limit of normal 
U.S. 
United States 
USP 
United States Pharmacopoeia 
VF 
virologic failure 
VL 
Viral load 
WHODD 
World Health Organization Drug Dictionary 

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1. Introduction 
 
1.1 
Background 
TaiMed Biologics, Inc. has developed a monoclonal antibody (MAb), ibalizumab-uiyk (Trogarzo®, 
formerly TNX-355, TMB-355 and Hu5A8), to be used in combination with an optimized 
background regimen (OBR) to treat human immunodeficiency virus type 1 (HIV-1) infected 
treatment-experienced subjects who are multi-drug resistant.  The approved drug Trogarzo® is 
administered intravenously over 15 minutes after dilution in physiological saline at an initial loading 
dose of 2000 mg with maintenance doses of 800 mg administered once every 2 weeks (q2wk).  The 
current study evaluates the safety and pharmacokinetics of the undiluted drug administered during 
the maintenance phase at 800 mg q2wk as an intravenous (IV) push over 30 seconds or as an 
intramuscular (IM) injection.  The possibility of administering the undiluted drug as an IV push or as 
an IM injection would avoid occasional saline shortages, simplify drug administration for the 
pharmacy and health practitioner and improve subject adherence.  If deemed comparable to 
administration by IV infusion (IVI), administration by IV push or IM injection would be desirable to 
improve the logistics of administration by eliminating the need for saline bags and infusion 
apparatus as well as improving convenience for subjects and physicians. 
 
In 2012, over 35 million people worldwide were living with human immunodeficiency virus (HIV) 
infection and 1.6 million people died from HIV/acquired immunodeficiency syndrome (AIDS).1 
Currently available treatment regimens (referred to as antiretroviral therapy [ART]) are composed of 
medications to inhibit HIV-1 replication and viral entry.  In regions of the world like the United 
States with access to antiretroviral medications, combination ART successfully controls HIV 
replication in a majority of subjects that take the medications.  However, approximately 20% of 
subjects in the United States (U.S.) still fail to achieve the goal of HIV treatment, suppression of 
viral replication to undetectable levels. Even in subjects who initially benefit from ART, 
development of drug resistance and severe side effects are major concerns.2  Additional treatment 
modalities are urgently needed. 
 
Other therapies designed to prevent infection of host cells (i.e., entry inhibitors) are currently 
approved for treatment of HIV infection in treatment-experienced subjects.  Fuzeon® (enfuvirtide, 
T-20), a fusion inhibitor and Selzentry™ (maraviroc), a coreceptor antagonist have both been shown 

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to be efficacious when combined with an OBR in treatment-experienced subjects.3,4,5  Trogarzo®, a 
MAb, is a cluster of differentiation 4 (CD4)-directed post-attachment inhibitor that also blocks HIV 
entry and is approved for use in combination with other approved antiretroviral (ARV) medications 
in treatment-experienced subjects with multi-class resistant HIV-1. 
 
Clinical trials conducted with IV Trogarzo® to assess safety and efficacy are described in the sections 
that follow.  The safety data from two small studies with subcutaneous (SC) and IM administration 
are also discussed.  
 
1.2 
Clinical Studies 
Prior studies with Trogarzo® administered via IVI have been conducted in HIV-positive individuals 
and are summarized below.  In addition, a study of Trogarzo® administered subcutaneously 
(Study TMB-108) to HIV-negative at-risk volunteers has been completed as has a study 
(Study TMB-121) exploring both SC and IM administration routes in both HIV-negative and HIV-
positive participants. 
 
Results from the Phase 1a clinical trial (Hu5A8.01) demonstrated that IV administration of a single 
dose of Trogarzo® to HIV-infected subjects was associated with dose-dependent mean viral load 
reductions of approximately 1 log10 in those receiving doses of 10 mg/kg or greater.  Mean viral load 
reductions persisted for 2-3 weeks.  In a subsequent Phase 1b study (Study TNX-355.02) Trogarzo® 
was given to HIV-infected subjects as a single agent (monotherapy) or added to failing ART.  
Multiple doses of Trogarzo® again demonstrated clinically significant viral load reductions (median 
reductions approximately 1 log10) with viral load nadirs at 1-2 weeks.  A 24-week, double-blind, 
placebo-controlled, randomized, three-arm Phase 2a study (Study TNX-355.03) evaluated the safety, 
efficacy, and pharmacokinetic (PK) activity of 2 Trogarzo® dose regimens (10 mg/kg and 15 mg/kg) 
in combination with an OBR versus placebo with an OBR in treatment-experienced subjects.  As in 
the Phase 1 program, the Phase 2a study clearly demonstrated the antiviral activity of Trogarzo®.  
Viral load reductions in the treatment arms were statistically significantly different from placebo, 
with approximately 1 log10 reductions seen in the Trogarzo®-containing arms at 24 weeks (primary 
endpoint) and at 48 weeks.  Also at 48 weeks, increases in CD4+ T-cell counts of approximately 
+50 cells/µL were observed for both of the active treatment arms versus virtually no change from 
baseline for the placebo arm (+1 cell/µL). 
 

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All single-dose and multiple-dose administrations of Trogarzo® were generally well tolerated with no 
serious adverse events (SAEs) related to study drug, no dose-limiting toxicities related to study drug, 
and no evidence of adverse effects on the CD4+ T-cells of treated subjects.  When compared with 
placebo (Phase 2a) the incidences, spectrum, and intensity of adverse events (AEs) were similar 
between the active treatment arms and the placebo arm. Although no statistically significant 
difference in incidence was observed between either of the active treatment arms and the placebo 
arm, rash (mostly mild to moderate severity) did occur more often in active treatment arms than in 
the placebo arm.  This observation appears to be consistent with the known association of rash with 
administration of humanized MAb medications.6  The administration of Trogarzo® was not 
associated with immunosuppression, as evidenced by the lack of any increase in infections or 
malignancies in the study population treated with Trogarzo®.  Intradermal skin tests performed on a 
subset of subjects were also similar between active treatment arms and placebo.  Anti-Trogarzo® 
antibodies have been detected transiently and at low titers in a small number of subjects (2.4%).  The 
observation of anti-Trogarzo® antibody activity was not associated with any AEs and appeared to 
have no impact on antiviral efficacy.  The significance of anti-Trogarzo® antibodies is not known. 
 
A Phase 2b clinical trial (Study TMB-202) in 113 HIV-infected subjects was also completed.  Heavily 
treatment-experienced (HTE) subjects enrolled in this study received IV doses of 800 mg of 
Trogarzo® q2wk or 2000 mg every 4 weeks (q4wk) in combination with an OBR.  The key primary 
efficacy endpoint was the proportion of subjects with HIV-1 ribonucleic acid (RNA) levels below 
the assay limit (<50 copies/mL) at Week 24.  The percent of subjects with <50 copies/mL at 
Week 24 were 44% and 28% for the 800 mg q2wk arm and the 2000 mg q4wk arm respectively in 
the most stringent intent-to-treat (ITT) missing equals failure (MEF) analysis.  Other noteworthy 
efficacy endpoints included mean change from Baseline in HIV-1 ribonucleic acid (RNA) at 
Week 24 and mean change in CD4+ T-cell counts.  The mean change from Baseline at Week 24 was 
-1.6 log10 for the 800 mg q2wk arm and -1.5 log10 for the 2000 mg q4wk arm.  The mean change 
from Baseline in CD4+ T-cells at Week 24 was + 37 cells/μL for the 800 mg q2wk group and 
+40 cells/μL for the 2000 mg q4wk group.  These results are consistent with quantitative measures 
of immune system recovery in a treatment-experienced population over 24 weeks in studies of other 
drugs.  There was no statistically significant difference between the 800 mg q2wk and 2000 mg q4wk 
arms in viral load outcomes at 24 weeks. 
 
Similar to previous studies, Trogarzo® in combination with OBR was well tolerated in the Phase 2b 
investigation.  The incidences, spectrum, and intensity of AEs were similar across the two treatment 

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arms.  A total of 15 SAEs were reported in 14 randomized subjects, and all SAEs were assessed as 
not related to study drug.  The most frequent non-laboratory AEs were rash (13%), diarrhea (12%), 
and headache (9%); most did not result in discontinuation.  Other clinical treatment-emergent 
adverse events (TEAEs) that were reported in ≥5% of subjects were nausea, nasopharyngitis, upper 
respiratory tract infection, cough, oral candidiasis, vomiting, and fatigue.  Only rash and headache 
were considered treatment-related TEAEs in ≥5% of subjects on study.  One treatment-related 
TEAE (moderate rash) resulted in study discontinuation.  Based on the overall study results, the 
800 mg q2wk dose and the 2000 mg q4wk dose demonstrated safety and efficacy in this treatment-
experienced HIV positive subject population. 
 
Study TMB-301 was a Phase 3, single-arm, 24-week, multicenter study of Trogarzo® plus an OBR in 
treatment-experienced subjects infected with multi-drug resistant HIV-1.  The primary objective was 
to demonstrate the antiviral activity of Trogarzo® at Day 14 and at Week 25 (end of study [EOS]).  
The secondary objectives were to assess the safety and tolerability of Trogarzo® through Week 25 
(EOS), assess the mean change from Day 7 (Baseline) in CD4+ cell count at Week 25 (EOS), HIV-1 
sensitivity/susceptibility changes associated with protocol-defined virologic failure (VF) after 
Trogarzo® administration in combination with OBR, determine the presence and significance of 
anti-Trogarzo® antibodies, if any (immunogenicity of Trogarzo®), assess the CD4 receptor density 
and occupancy, and determine the impact of Trogarzo® on quality of life (QoL) as assessed by 
subject-reported outcomes . 
 
A total of 63 HTE HIV-positive subjects were screened and 40 were enrolled into the study and 
received at least one dose of study drug.  At Day 14, using the ITT–MEF analysis, 33 subjects 
(82.5%) achieved a protocol-defined virologic endpoint (virologic response), with 1 subject (2.5%) 
achieving a complete virologic response (viral load <50 HIV-1 RNA copies/mL).  At Week 25 
(EOS), viral load <50 HIV-1 RNA copies/mL (complete virologic response) was reached in 43% of 
subjects.  Virologic failure was reported in 17.5% of subjects at EOS.  Overall, 32 subjects (80%) 
received all scheduled doses of study drug, and 31 subjects (77.5%) completed all scheduled visits in 
the study.  Of the 9 subjects not completing the study (did not complete all scheduled study visits), 
4 subjects were discontinued because of death (Kaposi’s sarcoma, lymphoma, hepatic failure, and 
asthenia) and 1 additional subject was discontinued because of an SAE (progressive multifocal 
leukoencephalopathy [PML]).  None of the deaths was considered to be related to Trogarzo®.  All 
other reasons for discontinuation were reported in a single subject each (physician’s decision, 
withdrawal by subject, subject noncompliance, and lost to follow-up).  One of the subjects who died 

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completed the study treatment but did not complete the study (thus 8 subjects discontinued study 
treatment).   
 
Examination of all resistance test results for subjects enrolled in the study revealed extensive ARV 
resistance and medical history findings were consistent with a population of HTE HIV-positive 
subjects. 
 
In this study of Trogarzo® with OBR in treatment-experienced subjects infected with multi-drug 
resistant HIV-1, 80% of subjects reported at least 1 TEAE and 17.5% of subjects reported at least 
1 treatment-related TEAE.  Severe TEAEs (Grade 3 or 4) were reported in 27.5% of subjects and 
Class C TEAEs were reported in 10% of subjects.  The most common TEAE was diarrhea 
(reported by 20% of the subjects) and was considered related to Trogarzo® in approximately 7.5% of 
subjects. 
 
On the basis of results from Study TMB-301, and also Study TMB-202, Trogarzo® was approved by 
the U.S. Food and Drug Administration (FDA) for treatment of multi-class resistant HIV.  
Trogarzo® is the first approved agent in a new class of HIV entry inhibitors, known as CD4-directed 
post-attachment HIV-1 inhibitors. 
 
Study TMB-121 was a study conducted in Taiwan with Trogarzo® administered via SC or IM 
injection.  The study was a Phase 1/2, randomized, placebo-controlled, safety, tolerability, PK, and 
pharmacodynamic (PD) study of SC and IM Trogarzo® administered to HIV-1-infected and healthy 
HIV-negative volunteers at-risk of acquiring HIV-1 infection. 
 
The study investigated two cohorts – HIV-1-infected volunteers (Cohort 1), and healthy 
HIV-negative volunteers at-risk of acquiring HIV-1 infection (Cohort 2).  Cohort 1 consisted of 
HIV-1 seropositive subjects who had not received ART for 1 year prior to entry, with HIV-1 RNA 
≥5000 copies/mL Cohort 1, consisting of 35 volunteers, enrolled into six study dosage arms.  Eight 
volunteers were enrolled into Arm 1A (600 mg q4wk SC, total of 2 administrations), 7 volunteers 
into Arm 1B (450 mg followed by 180 mg once a week [qwk] SC, total of 4 administrations), 
6 volunteers into Arm 1C (1200 mg q4wk IM, total of 2 administrations).  Analysis of data from 
Cohort 1C were used to make the decision to not enroll Arm 1D.  Eight volunteers were enrolled 
into Arm 1E (800 mg q2wk IM, total of 3 administrations).  After the completion of Arm E 
enrollment, 6 volunteers were enrolled into Arm 1F (2000 mg q4wk IM, total of 2 administrations). 

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Cohort 2 enrolled six HIV-negative at-risk volunteers into Arm A.  Participants in Arm 2A (900 mg 
IM weekly for 2 administrations followed by q4wk, total of 4 administrations).  Cohort 2 subjects 
were also evaluated on the basis of their ability to mount an immune response against novel antigen 
challenge with Hepatitis A vaccine, and novel/recall antigen challenge with tetanus toxoid. 
 
Volunteers in Arms 1C, and 1F were followed through Day 70 of the study; Volunteers in Arm 1E 
were followed through Day 56. 
 
Of the 41 subjects completing the study, 18 subjects (43.9%) experienced TEAEs, including 2 of 
2 subjects (100.0%) in the placebo group and 16 of 39 subjects (41.0%) in the Trogarzo® group. 
 
Although most reported events were considered not related to study drug, 6 of 39 subjects (15.4%) 
experienced treatment-related AEs.  The most frequently reported treatment-related AEs were in 
the System Organ Class (SOC) of skin and subcutaneous tissue disorders (reported in 4 of 
39 subjects, 10.3%) including 1 subject in Arm 1C .  The second most frequently reported 
treatment-related AEs were in the SOC of in general disorders and administration site conditions 
(reported in 2 of 39 subjects, 5.1%) and occurred in Arm 1C.  There were no treatment-related AEs 
reported in Cohort 2 Arm A.  All of the AEs were mild to moderate in severity. 
 
No subjects had any changes from baseline laboratory values that raised any clinical concerns. 
Likewise, there were no physical examination findings or vital signs that raised any clinical concerns. 
 
No injection-site reactions or evidence of reactogenicity were reported in Arms 1E, 1F, and 2A.  All 
(100.0%) subjects in Arm 1B (7 of 7 subjects) reported an injection-site reaction at one or more 
injection sites on Day 0, and 3 of 6 subjects (50%) in Arm 1C reported injection-site reactions on 
Day 0.  Injection-site reactions were still observed in subsequent visits, but the incidences were equal 
or lower when compared with Day 0.  There were neither SAEs nor discontinuations due to AEs 
reported during the study. 
 
Anti-Trogarzo® antibodies were detected in 1 subject (1 of 41 subjects, 2.4%).  The nonresponse to 
the Hepatitis A vaccine in a qualitative assay reported in half (3 of 6, 50.0%) of HIV-negative 
subjects at Week 7 was temporary and was restored in all subjects at Week 27 and Week 31.  No 

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negative effect on mounting tetanus antibody response was seen in HIV-negative subjects receiving 
Trogarzo®. 
 
In conclusion, Trogarzo® delivered by IM injection to HIV-negative at-risk volunteers at doses of 
900 mg (Days 0, 7, 35, and 63) was safe and well tolerated.  Trogarzo® delivered by IM injection to 
HIV-1 infected subjects (Arms 1C, 1E, and 1F) was safe and well tolerated. 
 
Taken together, the reported results of completed clinical studies suggest that Trogarzo® is safe and 
has potent activity against HIV in humans when administered by IV infusion, SC injection, and IM 
injection. 
 
1.3 
Pharmacokinetic and Pharmacodynamic Profile 
Intravenous administration of escalating single doses of Trogarzo® (Study Hu5A8.01) demonstrated 
that serum concentrations of Trogarzo® generally peaked at the end of the infusion period.  
Trogarzo® pharmacokinetics were dose-dependent, as both systemic exposure and elimination half-
life increased disproportionately with increasing dose.  This indicated that the elimination of 
Trogarzo® is capacity limited and saturable at higher doses.  A similar conclusion was reached after a 
multiple-dose study of IV Trogarzo® (Study TNX-355.02), which demonstrated that the steady-state 
half-life following multiple doses of 10 and 25 mg/kg was 75 and 79 hours, respectively.  The 
capacity-limited elimination is likely due to CD4 receptor turnover, given the short half-life for 
Trogarzo® relative to endogenous immunoglobulin 4 (IgG4) molecules.  In the IV Trogarzo® studies 
conducted to date, there was a correlation between Trogarzo® trough serum concentrations of 
0.3 µg/mL or higher and saturated binding of CD4 (receptor occupancy) on CD4+ T-cells, and 
between CD4 receptor occupancy and reductions in HIV viral load.  
 
The Phase 2b trial (Study TMB-202) investigated the correlation between Trogarzo® serum 
concentration, using an assay with 100 ng/mL sensitivity, and CD4 receptor occupancy.  Paired 
measurements for individual subject samples were evaluated.  Data were available for pre-dose 
samples collected at Baseline through Week 24, along with Baseline post-dose samples.  The data 
evaluated were confined to those samples for which both serum Trogarzo® and receptor occupancy 
measurements were reported.  Pharmacokinetic data were censored (as described in the clinical study 
report [CSR] Appendix 16.5) and receptor occupancy data were censored accordingly (mainly to 
eliminate outliers resulting from improper sample collection and/or labeling).  

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Eighty-four percent of pre-dose samples collected at Baseline had Trogarzo® levels below the limit 
of detection (<100 ng/mL). The remaining samples (16%) had detectable levels of serum 
Trogarzo®, generally in the range of 100 to 200 ng/mL, despite no prior treatment with Trogarzo®.  
As expected for pre-dose samples, all were reported to have had low receptor occupancy (<32%), as 
indicated previously.  Although low but detectable levels of Trogarzo® may result from faulty sample 
collection or sample handling, it may also be due to interference with measurements of low serum 
Trogarzo® concentrations for specific subjects.  This could confound attempts to correlate PD 
parameters with serum Trogarzo® concentrations in the range of 100 to 200 ng/mL, at least for 
certain subjects.  
 
Serum Trogarzo® concentrations ranged from <100 to >100,000 ng/mL, collectively, for Baseline 
samples (pre-dose and post-dose) and pre-dose samples from Weeks 2 through 24.  Comparison 
with receptor occupancy measurements indicated a direct relationship between serum Trogarzo® 
levels and CD4 receptor occupancy.  A greater proportion of samples having intermediate or high 
receptor occupancy was evident with serum Trogarzo® concentrations ≥150 ng/mL.  At serum 
Trogarzo® concentrations >300 ng/mL, over 90% of all samples were reported to have high 
receptor occupancy (median = 100% receptor occupancy). 
 
In the Phase 3 study (Study TMB-301), 40 HIV-positive subjects received a 2000 mg Trogarzo® 
loading dose followed by 800 mg q2wk by IVI.  The assay sensitivity for serum Trogarzo® 
concentration was 10 ng/mL.  The maximum serum concentrations were observed immediately 
after the end of the 2000 mg Trogarzo® infusion. Steady state was reached at Week 4 after the first 
dose.  The mean Trogarzo® concentrations were >30 μg/mL and the CD4 receptor occupancy was 
>85% throughout the dosing period, suggesting that the regimen was sufficient to maintain the drug 
concentration above the therapeutic level.  The loading dose effect was substantial.  With the loading 
dose, the percentage of subjects below effective concentration and receptor occupancy decreased 
from ~50% to ~20% at Week 2 after the first dose by comparison between the TMB-202 and 
TMB-301 studies.  At Week 24 after the first dose, Trogarzo® serum concentration and receptor 
occupancy were comparable between these two regimens. 
 
Both Day 7 concentration (peak concentration, Cpeak) and Week25 trough concentration (Ctrough) 
were decreased with increased body weight.  The median Ctrough in the high body weight group 

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(>85 kg) was 0.23 μg/mL, which was close to the concentration necessary to support 85% receptor 
occupancy.  
 
The elevations in CD4 receptor occupancy were generally associated with increased Trogarzo® 
serum concentrations.  Trogarzo® serum concentrations greater than 0.13 μg/mL supported 85% 
CD4 receptor occupancy.  Following Trogarzo® administration, transient down-modulation of 
surface CD4 receptors by up to 20% was observed.  The maximum HIV viral load reduction 
was -2.35 log10 occurring at Week 8 after the first dose and were maintained throughout the dosing 
period.  There were no apparent associations between Trogarzo® serum concentrations and receptor 
density and viral load reduction, respectively. 
 
Trogarzo® serum concentrations following IM administrations were determined in Study TMB-121.  
Subjects in Arm 1E received 800 mg IM q2wk for three doses.  The mean Trogarzo® serum 
concentration in these subjects reached a maximum after 2 to 3 days (time to maximum 
concentration [Tmax] = 2.13) and declined to 5.1 μg/mL at Day 14.  The mean trough concentrations 
at 14 days post-dose (Days 14, 28, and 42) were all greater than the effective concentration 
(0.3 μg/mL), and 63% of subjects’ trough concentrations were greater than 0.3 μg/mL.  These 
preliminary results indicate that 800 mg was sufficient for a q2wk dosing schedule for the majority 
of subjects.  As shown in Figure 1, the mean ibalizumab concentrations after 800 mg IM ibalizumab 
injections were comparable with IV ibalizumab injections (TMB-202 results).  
 

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Figure 1 
Mean (± SD) Ibalizumab Serum Concentrations after 800 mg IM and 
IV Administration 
 
 
In addition, a population PK model was developed using the PK data from six clinical studies 
conducted in HIV-infected patients (Studies Hu5A8.01, TNX355.02, TNX355.03, TMB-202, 
TMB-301, and TMB-121).  One-hundred subjects with body weight ranging from 50-140 kg were 
simulated to receive a 2000 mg loading dose via IVI followed by 800 mg IM q2wk dosing. 
Trogarzo® serum concentrations remained above the effective concentration (0.3 μg/mL) 
throughout the dosing period, consistent with clinical data. 
 
2. Study Objectives 
 
2.1 
Primary Objectives 
The primary objectives of this study are to: 
 
◼ 
Evaluate the safety of Trogarzo® administered as an undiluted “IV push” over 30 seconds 
and by IM injection in clinically-stable HIV-1 infected subjects with at least 3 months of 

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stable treatment with a Trogarzo®-containing ARV regimen or in healthy HIV-uninfected 
volunteers 
 
◼ 
Compare the area under the curve (AUC) and trough serum drug concentration after IVI with 
the diluted drug to the AUC and trough serum concentration after IV push of undiluted 
Trogarzo® 
 
◼ 
Compare the trough serum drug concentration after IVI with the diluted drug to the trough 
serum concentration after IM injection of undiluted Trogarzo® 
2.2 
Secondary Objectives 
The secondary objectives of this study are to: 
 
◼ 
Assess HIV-1 viral load for IVI compared to IV Push and to IM injection in HIV-1 infected 
subjects only 
 
◼ 
Characterize noted HIV-1 sensitivity/susceptibility changes in participants with an increase in 
plasma viral load to levels above 1,000 copies/mL on 2 consecutive measurements at least 
2 weeks apart in HIV-1 infected subjects only 
 
◼ 
Determine the presence and significance of anti-Trogarzo® antibodies, if any (immunogenicity 
of Trogarzo®) 
 
◼ 
Compare the AUC after IVI with the diluted drug to the AUC after IM injection of undiluted 
Trogarzo® 
3. Study Plan 
 
3.1 
Overall Design 
The goal of this Phase 3 study is to evaluate the safety of administering Trogarzo® 800 mg q2wk as 
an undiluted IV push over 30 seconds or as IM injection in clinically stable HIV-1 infected subjects 
currently receiving treatment with a stable Trogarzo®-containing regimen and in HIV-uninfected 
healthy volunteers who receive Trogarzo® as either an IV push or as an IM injection after achieving 
a steady-state level of Trogarzo® after a 2000 mg loading dose followed by 3 IVI of 800 mg 
Trogarzo® q2wk.  A stable regimen is defined as having no changes in dose or frequency and no 
interruptions ≥2 weeks during the 3-month period preceding Screening.  For subjects who receive 
Trogarzo® as an IV push (Core Group) and then continue in the study and receive Trogarzo® as an 

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IM injection (IM Group), the time period while receiving the IV push will be considered as having 
received a stable Trogarzo®-containing ARV regimen.   
Note: HIV-infected subjects who are enrolled in the IM injection study and are unable to adhere to 
the study schedule for IM dosing due to factors outside the study will be discontinued. Re-
enrollment of HIV-infected IM Group subjects will be allowed after a Discontinuation Visit and 
rescreening visit are completed provided that inclusion/exclusion criteria continue to be satisfied 
and dosing after discontinuation is resumed according to the Trogarzo® Prescribing Information.  
For re-enrolling subjects, the inclusion criteria for stable a Trogarzo®-containing ARV regimen is 
satisfied with a loading dose of 2000mg IVI and at least one maintenance dose of 800mg IVI given 
according to Trogarzo® labeling prior to Day 1 enrollment. 
The first five (5) subjects enrolled will comprise the Sentinel Group. Subjects six (6) through twenty 
(20) (the Core Group) will not be screened until the Sentinel Group has completed Day 99 
(14 weeks) of the study and the Data Monitoring Committee (DMC) has reviewed the data 
accumulated and given approval for enrollment of the Core Group to proceed. 
An additional group of approximately 20 subjects (the IM Group), which will include subjects 
receiving Trogarzo® as an IM injection, will also be evaluated.  Subjects who have previously 
received Trogarzo® as an IV push are permitted to screen/enroll for participation in the IM Group.  
Subjects for inclusion in the IM Group who were part of Sentinel or Core Groups will enter the IM 
Group only once they have completed the Sentinel or Core study.  New subjects enrolled in the IM 
Group who were not part of the Sentinel or Core Groups will be recruited only once all Core Group 
subjects have been enrolled and completed the Core study.  These subjects may be HIV-infected 
or -uninfected. 
 
Sentinel Group 
Subjects in the Sentinel Group will receive an 800 mg maintenance dose of Trogarzo® in accordance 
with the prescribing information (diluted in normal saline and administered over 15 minutes via IVI) 
at Day 1/Baseline and again at Day 15.  Every 2 weeks thereafter through Day 85 (12 weeks), 
subsequent maintenance doses will be administered at increasing concentrations and over decreasing 
intervals according to the following schedule: 
◼ 
Day 1/Baseline: 800 mg diluted in 250 mL normal saline (at 3.2 mg/mL) via IVI over 
15 minutes per approved Trogarzo® prescribing information 

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◼ 
Day 15: 800 mg diluted in 250 mL normal saline (at 3.2 mg/mL) via IVI over 15 minutes per 
approved Trogarzo® prescribing information 
◼ 
Day 29 (4 weeks): 800 mg diluted in 50 mL normal saline (at 16 mg/mL) via IVI over 
10 minutes 
◼ 
Day 43 (6 weeks): 800 mg diluted in 16 mL normal saline (at 50 mg/mL) via IV bolus over 
5 minutes 
◼ 
Day 57 (8 weeks): 800 mg diluted in 8 mL normal saline (at 100 mg/mL) via IV bolus over 
1 minute 
◼ 
Day 71 (10 weeks): 800 mg undiluted (at 150 mg/mL) via IV push over 30 seconds 
◼ 
Day 85 (12 weeks): 800 mg undiluted (at 150 mg/mL) via IV push over 30 seconds 
For the EOS visit at Day 99 (14 weeks), Sentinel Group subjects will revert to diluted IVI dosing 
over 15 minutes in accordance with the Trogarzo® prescribing information. When five (5) subjects 
in the Sentinel Group have completed Day 99 (14 weeks) of the study, the DMC will review the 
available data to determine whether the enrollment of the Core Group should proceed.  
Core Group 
HIV-infected individuals: After DMC review and approval, the Core Group (subject numbers six 
[6] through twenty [20]) will be enrolled.  Subjects in the Core Group will also receive an 800 mg 
maintenance dose of Trogarzo® in accordance with the prescribing information (diluted in normal 
saline and administered over 15 minutes via IVI) at Day 1/Baseline and again at Day 15.  Every 
2 weeks thereafter through Day 71 (10 weeks), maintenance doses will be administered via undiluted 
IV push over 30 seconds.  At Day 85 (12 weeks), Core Group subjects will revert to diluted IVI 
dosing over 15 minutes in accordance with the Trogarzo® prescribing information. 
HIV-uninfected individuals: 
Pre–Steady-State Phase: Subjects will receive a 2000 mg infusion of Trogarzo® over 60 minutes on 
Day -55 followed by 3 doses of 800 mg infusion over 15 minutes on Days -41, -27, and -13.  On 
Day 1 the subjects will enter the Study Treatment Phase. 
Study Treatment Phase:  These HIV-uninfected subjects will receive an 800 mg dose of 
Trogarzo® in accordance with the prescribing information (diluted in 250 mL normal saline and 
administered over 15 minutes via IVI) at Day 1/Baseline and again at Day 15.  Every 2 weeks 
thereafter through Day 71 (10 weeks), subsequent doses will be administered via undiluted IV push 
over 30 seconds.  After the Day 71 IV push dose, HIV-uninfected Core Group subjects discontinue 
Trogarzo® therapy. 

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Pharmacokinetic samples will be collected in the study to evaluate serum concentrations and the PK 
profile of Trogarzo®.  In particular, data will be collected to compare serum drug concentrations 
(AUC and trough) after IVI of the 800 mg diluted drug over 15 minutes to IV push of the undiluted 
drug over 30 seconds.  Pre-dose samples will be collected at selected timepoints, along with samples 
at 1, 24, and 72 hours post-dose, and 7 and 14 days post-dose for the first two doses of study drug 
(via IVI) for HIV-infected participants and after steady state is achieved in HIV-uninfected healthy 
volunteers, and for all 30-second IV push doses for all subjects in the Sentinel and Core Groups (see 
Table 1, Table 2, and Table 3 for sample collection timepoints).  Samples collected at the 24- and 
72-hour post-dose timepoints, and those collected at the 7-day post-dose timepoints when a study 
visit is not otherwise already scheduled will require additional visits for PK sample collection only. 
IM Group 
The IM Group will enroll either subjects who were enrolled and completed the study from the 
Sentinel and Core groups or other subjects new to the study who were not previously involved in 
the IV push portions.  Subjects for inclusion in the IM Group will be recruited only once all subjects 
for the Core Group have been enrolled in and completed the Core study.  
HIV-infected individuals:  Subjects will receive the first two doses of study drug in accordance 
with the Trogarzo® prescribing information (diluted in normal saline and administered over 
15 minutes via IVI) at Day 1/Baseline and again at Day 15.  The next four doses of Trogarzo® 
through Day 71 (10 weeks) will be administered as an IM injection.  At Day 85 (12 weeks), IM 
Group subjects will revert to diluted IVI dosing over 15 minutes in accordance with the Trogarzo® 
prescribing information. For re-enrolling subjects, a loading dose of 2000mg IVI and at least one 
maintenance dose of 800mg IVI will be given according to the label to re-establish study eligibility 
from a Trogarzo® dosing perspective starting at least 4 weeks prior to Day 1.  The day of the 
2000mg loading dose may also serve as the Discontinuation or Screening Visit, as appropriate for 
subject and study site scheduling needs for re-enrolling subjects. 
HIV-uninfected individuals: 
Pre–Steady-State Phase:  Subjects will receive four doses of Trogarzo® as described above for 
Core Group HIV-uninfected individuals prior to the Study Treatment Phase. 
Study Treatment Phase:  HIV-uninfected subjects in the IM Group will receive the first two doses 
of study drug in accordance with the Trogarzo® prescribing information (diluted in normal saline 
and administered over 15 minutes via IVI) at Day 1/Baseline and again at Day 15.  The next four 

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doses of Trogarzo® will be administered as an IM injection.  HIV-uninfected subjects will 
discontinue dosing after the Day 71 study drug administration.  
A total volume of 5.32 mL, corresponding to 800 mg Trogarzo®, will be injected intramuscularly and 
will be split into two injections of approximately 2.66 mL each.  The two IM injections should be 
administered in the muscle tissue of the subject’s anterolateral aspect of the thighs (left, right, or 
both) or alternatively in the dorsogluteal site (upper outer quadrant of the buttock).  In either area, 
injections sites should be at least 1 inch apart. 
For the PK profile of Trogarzo® following IM administrations, pre-dose samples will be collected at 
selected timepoints, along with samples at 2, 7, 10, and 14 days post-dose for the last two doses of 
study drug (via IVI), and for the last two IM injection doses for all subjects (see Table 4 for sample 
collection timepoints).  Samples collected at the 2-, 7-, 10- and 14-day post-dose timepoints when a 
study visit is not otherwise already scheduled will require additional visits for PK sample collection 
and injection site assessment only. 
All Groups 
After each study drug administration, all HIV-infected study subjects in both groups will be 
observed for at least 15 minutes, and HIV-uninfected subjects will be observed for at least 
60 minutes.  All AEs will be recorded. Vital signs will be measured and recorded at the beginning 
and end of this observation period. 
Clinical site personnel and emergency medications and equipment will be available to manage any 
infusion or injection reactions as medically indicated.  Hypersensitivity reactions including infusion-
related reactions and anaphylactic reactions have been reported following infusion of Trogarzo® 
during post-approval use.  Subjects should be monitored closely for such symptoms during 
observation (see Appendix C for information on management of anaphylactic symptoms). 
Injection site reactions will be assessed in subjects who receive IM injections of Trogarzo® at each 
visit during IM administration and follow-up. 
Subjects will be monitored through 28 days after the last administration of Trogarzo® on study: from 
Day 85 (12 weeks) through Day 113 (16 weeks) for the Sentinel Group and for HIV-infected 
subjects in the Core and IM Groups and from Day 71 (10 weeks) through Day 99 (14 weeks) for the 
HIV-uninfected Core and IM Group participants.  Refer to Section 4.3 for the study Safety 
Monitoring and Toxicity Management Plan, and to Section 4.4 for the Study Stopping Rules. 
 

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3.2 
Discussion of Trial Design 
This study is designed to assess the safety and PK profile (serum AUC and Ctrough) and of 800 mg 
Trogarzo® q2wk administered via IV push (undiluted drug administered over 30 seconds) or as IM 
injection compared with the approved Trogarzo® administration (diluted in 250 mL normal saline 
administered intravenously over 15 minutes).  The study will also assess the maintenance of 
established virologic control, characterize changes in the viral susceptibility/resistance in 
HIV-infected subjects, and the development of anti-drug antibodies in all subjects as secondary 
endpoints.  If deemed comparable to administration by IVI, administration by IV push or as IM 
injection would be desirable to improve the logistics of administration by eliminating the need for 
saline bags and infusion apparatus as well as improving convenience for subjects and physicians. 
 
3.3 
Dose Selection 
The efficacy and safety of Trogarzo® in Study TMB-301, a Phase 3 trial, where a single 2000 mg 
loading dose was followed by 800 mg q2wk maintenance, was the basis for the U.S. approval of the 
commercial drug, Trogarzo®, for the treatment of HIV-1 infected subjects with multi-class resistance 
in combination with an optimized background ARV regimen.  The approved regimen administers 
diluted drug over 15-minute infusions.  The current study uses the same doses.  This study assesses 
the administration of the undiluted 800 mg maintenance drug dose IV over 30 seconds or as IM 
injection. 
 
3.4 
Schedule of Events 
Table 1 provides the Schedule of Events for the Sentinel Group in this study, from Screening 
through the follow-up visit at Day 113 (16 weeks).  Table 2 provides the Schedule of Events for 
HIV-uninfected individuals (Core and IM Groups) from the Screening visit through the end of the 
Pre-Steady State Phase.  Table 3 provides the Schedule of Events for the HIV-infected Core Group 
subjects from Screening through the follow-up visit at Day 99 (14 weeks) and for the 
HIV-uninfected subjects from Day 1 through Day 99 (EOS).  Table 4 provides the Schedule of 
Events for the HIV-infected IM Group from Screening through the follow-up visit at Day 113 
(16 weeks) and for the HIV-uninfected IM Group subjects from Day 1 through the follow-up visit 
at Day 99.  Throughout the study, subjects are not required to fast before collection of blood 

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samples.  However, subjects should adhere to dietary recommendations as suggested for the 
components of their antiretroviral treatment or other concomitant medications. 

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Table 1 
Schedule of Events – Sentinel Group (Subjects 1-5) 
 
Study Visit 
Screening 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 50 
(7 wks) 
Day 57 
(8 wks) 
Day 64 
(9 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
ACTIVITIES TO BE COMPLETED BEFORE STUDY DRUG ADMINISTRATION 
Review and discuss the 
Inclusion/Exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain a signed Informed 
Consent Form  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record demographics, 
medical history (general and 
HIV); height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record agents in ART 
history at Screening, 
changes in ART on-study 1 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
Record results of a complete 
physical examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record results of a targeted 
physical examination 2 
 
X 
 
 
 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Record vital sign 
measurements 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Record the subject’s weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record AEs 3 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Record concomitant 
medications 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
X 
X 
X 
BLOOD and/or URINE 4 SAMPLES TO BE COLLECTED 
Hematology and serum 
chemistry (see Section 7.2.1 
for list) 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
Urinalysis 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
HIV-1 RNA (viral load) 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
CD4+ cell count 
X 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 

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Study Visit 
Screening 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 50 
(7 wks) 
Day 57 
(8 wks) 
Day 64 
(9 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
Serum for pregnancy test for 
females of childbearing 
potential 5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine for pregnancy test for 
females of childbearing 
potential 
 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
 
Antiretroviral resistance 
sample 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
Archive serum sample 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
Trogarzo® serum 
concentration (pre-dose if 
drug administered on this 
day) 6 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
 
X 
 
Trogarzo® serum 
concentration post-dose –  
1 hour (±10 min) 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Immunogenicity of 
Trogarzo® (2 tubes x 3 mL 
each) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY DRUG ADMINISTRATION AND AFTER 
Administer study drug via 
IVI – study drug diluted in 
250mL normal saline and 
administered IV over 15 
minutes per Trogarzo® 
prescribing information 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Administer study drug –
reducing administration 
time and increasing study 
drug concentration in step-
wise fashion at each visit per 
schedule 7 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
X 
 

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Study Visit 
Screening 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 50 
(7 wks) 
Day 57 
(8 wks) 
Day 64 
(9 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±1 
±1 
±1 
Observe subject for 15 
minutes post-
administration; record vital 
sign measurements after 
completion of infusion and 
again at end of observation 
period8 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
X 
 
1 All ART for the 3 months preceding Screening will be recorded at Screening visit; subsequent visits will only record changes to ART. 
2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system. 
3 Only record AEs that are related to study procedures before administration of the first dose. 
4 Subjects do not need to fast before blood sampling. 
5 Serum FSH test to be conducted on postmenopausal females at Screening only. 
6  Pre-dose samples to be collected within 1 hour before the start of the infusion; 24 hr, 72, hr, and 7 Day post dose samples to be collected within 3 hours of the time 
the infusion ended. 
7 At Baseline and at Day 15 all subjects in the Sentinel Group (the first 5 subjects enrolled) will receive study drug diluted into 250 mL normal saline as a standard 
800 mg IV infusion over 15 minutes, per Trogarzo® prescribing information. At Day 29, Sentinel Group subjects will begin receiving Trogarzo® 800 mg at increasing 
concentrations over decreasing intervals as follows: Day 29 (4 weeks) – 16 mg/mL delivered over 10 minutes (800 mg study drug diluted into 50 mL normal saline); 
Day 43 (6 weeks) – 50 mg/mL delivered over 5 minutes (800 mg study drug diluted into 16 mL normal saline); Day 57 (8 weeks) – 100 mg/mL delivered over 
1 minute (800 mg study drug diluted into 8 mL normal saline).  All subjects must be observed for 15 minutes after the completion of each study drug administration. 
Vital signs should be monitored and recorded at the beginning and end of the observation period. 
8 Any abnormalities observed need to be recorded on the AE CRF.   
 
 

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Schedule of Events – Sentinel Group (Subjects 1-5) (CONTINUED) 
 
Study Visit 
Day 71 
(10 wks) 
Day 72 Day 74 Day 78 
(11 wks) 
Day 85 
(12 wks) 
Day 86 
Day 88 
Day 92 
(13 wks) 
Day 99/EOS 
(14 wks) 
Day 113 Follow-Up 
(16 wks) 
Visit window (days) 
±1 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±3 hr 
±1 
±1 
ACTIVITIES TO BE COMPLETED BEFORE STUDY DRUG ADMINISTRATION 
Record agents in ART 
history at Screening, 
changes in ART on-study 1 
X 
 
 
 
X 
 
 
 
X 
 
Record results of a complete 
physical examination 
 
 
 
 
 
 
 
 
 
 
Record results of a targeted 
physical examination 2 
X 
 
 
X 
X 
 
 
X 
X 
 
Record vital sign 
measurements 
X 
 
 
X 
X 
 
 
X 
X 
 
Record the subject’s weight 
 
 
 
 
 
 
 
 
X 
 
Record Aes 3 
X 
 
 
X 
X 
 
 
X 
X 
X 
Record concomitant 
medications 
X 
 
 
X 
X 
 
 
X 
X 
X 
BLOOD and/or URINE 4 SAMPLES TO BE COLLECTED 
Hematology and serum 
chemistry (see Section 7.2.1 
for list) 
X 
 
 
 
X 
 
 
 
X 
 
Urinalysis 
X 
 
 
 
X 
 
 
 
X 
 
HIV-1 RNA (viral load) 
X 
 
 
 
X 
 
 
 
X 
 
CD4+ cell count 
 
 
 
 
 
 
 
 
X 
 
Serum for pregnancy test for 
females of childbearing 
potential 5 
 
 
 
 
 
 
 
 
X 
 
Urine for pregnancy test for 
females of childbearing 
potential 
 
 
 
 
X 
 
 
 
 
 
Antiretroviral resistance 
sample 
X 
 
 
 
X 
 
 
 
X 
 

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Study Visit 
Day 71 
(10 wks) 
Day 72 Day 74 Day 78 
(11 wks) 
Day 85 
(12 wks) 
Day 86 
Day 88 
Day 92 
(13 wks) 
Day 99/EOS 
(14 wks) 
Day 113 Follow-Up 
(16 wks) 
Visit window (days) 
±1 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±3 hr 
±1 
±1 
Archive serum sample 
X 
 
 
 
X 
 
 
 
X 
 
Trogarzo® serum 
concentration (pre-dose if 
drug administered on this 
day) 6 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Trogarzo® serum 
concentration post-dose –  
1 hour (±10 min) 
X 
 
 
 
X 
 
 
 
 
 
Immunogenicity of 
Trogarzo® (2 tubes x 3 mL 
each) 
 
 
 
 
 
 
 
 
X 
 
STUDY DRUG ADMINISTRATION AND AFTER 
Administer study drug via 
IVI – study drug diluted in 
250mL normal saline and 
administered IV over 15 
minutes per Trogarzo® 
prescribing information 
 
 
 
 
 
 
 
 
X 
 
Administer study drug –
reducing administration 
time and increasing study 
drug concentration in step-
wise fashion at each visit per 
schedule 7 
X 
 
 
 
X 
 
 
 
 
 
Observe subject for 15 
minutes post-
administration; record vital 
sign measurements after 
completion of infusion and 
again at end of observation 
period8 
X 
 
 
 
X 
 
 
 
X 
 
1 All ART for the 3 months preceding Screening will be recorded at Screening visit; subsequent visits will only record changes to ART. 

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2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system. 
3 Only record Aes that are related to study procedures before administration of the first dose; after administration of first dose. 
4 Subjects do not need to fast before blood sampling. 
5 Serum FSH test to be conducted on postmenopausal females at Screening only. 
6 Pre-dose samples to be collected within 1 hour before the start of the infusion; 24 hr, 72, hr, and 7 Day post dose samples to be collected within 3 hours of the 
time the infusion ended. 
7 At Day 71, Sentinel Group subjects receive Trogarzo® 800 mg at increased concentration over intervals reduced from the 15 minutes required for IV infusion 
as follows: Day 71 (10 weeks) – 150 mg/mL delivered over 30 seconds (800 mg study drug administered undiluted); Day 85 (12 weeks) – 150 mg/mL delivered 
over 30 seconds (800 mg study drug administered undiluted). At Day 99/EOS (14 weeks) subjects in the Sentinel Group will revert to receiving 800 mg 
Trogarzo® diluted into 250 mL normal saline as an IV infusion over 15 minutes, per Trogarzo® prescribing information. All subjects must be observed for 15 
minutes after the completion of each study drug administration. Vital signs should be monitored and recorded at the beginning and end of the observation 
period. 
8 Any abnormalities observed need to be recorded on the AE CRF.   
 
 
 

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Table 2 
Schedule of Events – HIV-uninfected Core and IM Groups Only (Subjects 6-40): Screening and Pre-
Steady State Phase: Day -83 to Day -13 
 
Screening Day – 55 Day -41 Day -27 Day -13 
Visit window (days) 
(-83 to -62 
days) 
N/A 
±1 
±1 
±1 
Review and discuss the Inclusion/Exclusion criteria 
X 
X 
 
 
 
Obtain a signed Informed Consent Form  
X 
 
 
 
 
Record demographics, medical history (general and HIV); height 
X 
 
 
 
 
Record results of a complete physical examination 
X 
 
 
 
 
Record results of a targeted physical examination 2 
 
X 
X 
X 
X 
Record vital sign measurements 
X 
X 
X 
X 
X 
Record the subject’s weight 
X 
 
 
 
 
Record AEs 3 
X 
X 
X 
X 
X 
Record concomitant medications 
X 
X 
X 
X 
X 
Hematology and serum chemistry (see Section 7.2.1 for list) 
X 
X 
X 
X 
X 
Urinalysis 
X 
X 
X 
X 
X 
CD4+ cell count 
X 
X 
 
X 
 
Hepatitis B surface antigen and hepatitis C antibody testing 
X 
 
 
 
 
4th Generation POC HIV test1 
X 
X 
 
X 
 
Serum for pregnancy test for females of childbearing potential 5 
X 
 
 
 
 
Urine for pregnancy test for females of childbearing potential 
 
X 
X 
X 
X 
Archive serum sample 
 
X 
X 
X 
X 
Trogarzo® serum concentration (pre-dose if drug administered on this day) 6 
 
X 
X 
X 
X 
Trogarzo® serum concentration post-dose – 1 hour (±10 min) 
 
X 
 
 
 
Immunogenicity of Trogarzo® (2 tubes x 3 mL each) 
 
X 
 
 
 
Administer 2000 mg study drug via IVI – study drug diluted in 250mL normal saline and administered IV over 
60 minutes per Trogarzo® prescribing information7 
 
X 
 
 
 
Administer 800 mg study drug via IVI – study drug diluted in 250mL normal saline and administered IV over 15 
minutes per Trogarzo® prescribing information7 
 
 
X 
X 
X 
Observe subject for 60 minutes post-administration; record vital sign measurements after completion of infusion 
and again at end of observation period8 
 
X 
X 
X 
X 
1 4th Generation Point of Care (POC) test should be done at the site and results recorded in the source document and CRF. 
2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system. 

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3 Only record Aes that are related to study procedures before administration of the first dose; after administration of first dose. 
4 Subjects need not fast before blood sampling. 
5 Serum FSH test to be conducted on postmenopausal females at Screening only. 
6 Pre-dose samples to be collected within 1 hour before the start of the infusion.  
7 HIV-1 uninfected Core Group will receive study drug diluted into 250 mL normal saline as a 2000 mg loading dose followed by three 800 mg IV infusions over 
15 minutes, per Trogarzo® prescribing information.  
8 Any abnormalities observed need to be recorded on the AE CRF.   
 
 

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Table 3 
Schedule of Events – HIV-infected Core Group (Subjects 6-20) and HIV-uninfected Core Group 
(Subjects 6-20; Days 1-99) 
 
Study Visit 
Screening* 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 44 
Day 46 
Day 50 
(7 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±3 hr 
±3 hr 
±1 
ACTIVITIES TO BE COMPLETED BEFORE STUDY DRUG ADMINISTRATION 
Review and discuss the 
Inclusion/Exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain a signed Informed 
Consent Form  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record demographics, 
medical history (general 
and HIV); height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record agents in ART 
history at Screening, 
changes in ART on-study 1 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
Record results of a 
complete physical 
examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record results of a 
targeted physical 
examination 2 
 
X 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
X 
Record vital sign 
measurements 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
X 
Record the subject’s 
weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record AEs 3 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
X 
Record concomitant 
medications 
X 
X 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
X 
BLOOD and/or URINE 4 SAMPLES TO BE COLLECTED 
Hematology and serum 
chemistry (see Section 7.2.1 
for list) 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 

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Study Visit 
Screening* 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 44 
Day 46 
Day 50 
(7 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±3 hr 
±3 hr 
±1 
Urinalysis 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
HIV-1 RNA (viral load)9 
X 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
4th Generation POC  HIV 
test10 
 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
CD4+ cell count 
X 
X 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Serum for pregnancy test 
for females of childbearing 
potential 5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine for pregnancy test 
for females of childbearing 
potential 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
Antiretroviral resistance 
sample9 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
Archive serum sample 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
Trogarzo® serum 
concentration (pre-dose if 
drug administered on this 
day) 6 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
Trogarzo® serum 
concentration post-dose –  
1 hour (±10 min) 
 
X 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
Immunogenicity of 
Trogarzo® (2 tubes x 3 mL 
each) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY DRUG ADMINISTRATION AND AFTER 
Administer study drug via 
IVI – study drug diluted in 
250mL normal saline and 
administered IV over 15 
minutes per Trogarzo® 
prescribing information 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 

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Study Visit 
Screening* 
Day 1 
Baseline 
Day 2 
Day 4 
Day 8 
(1 wk) 
Day 15 
(2 wks) 
Day 16 
Day 18 
Day 22 
(3 wks) 
Day 29 
(4 wks) 
Day 36 
(5 wks) 
Day 43 
(6 wks) 
Day 44 
Day 46 
Day 50 
(7 wks) 
Visit window (days) 
(-28 days) 
N/A 
±3 hr 
±3 hr 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±3 hr 
±3 hr 
±1 
Administer study drug via 
IVP – undiluted Push over 
30 seconds 7 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
Observe subject post-
administration – 15 
minutes if HIV-infected, 
60 minutes if uninfected; 
record vital sign 
measurements after 
completion of infusion and 
again at end of observation 
period8 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
 
 
 
 
* Screening visit to be conducted for HIV-infected patients ONLY. See Table 2 for Screening and Pre-Steady State Phase Schedule of Events 
1 All ART for the 3 months preceding Screening will be recorded at Screening visit; subsequent visits will only record changes to ART. 
2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system. 
3 Only record AEs that are related to study procedures before administration of the first dose; after administration of first dose. 
4 Subjects need not fast before blood sampling. 
5 Serum FSH test to be conducted on postmenopausal females at Screening only. 
6 Pre-dose samples to be collected within 1 hour before the start of the infusion; 24 hr, 72, hr, and 7 Day post dose samples to be collected within 3 hours of the time the 
infusion ended. 
7 At Baseline and at Day 15, subjects in the Core Group will receive study drug diluted into 250 mL normal saline as an 800 mg IV infusion over 15 minutes, per Trogarzo® 
prescribing information.  At Day 29 Core Group subjects will begin receiving study drug as 800 mg undiluted Trogarzo® administered by IV Push over 30 seconds once every 
2 weeks. 
8 Any abnormalities observed need to be recorded on the AE CRF.  
9 HIV-infected Core subjects only. 
10 HIV- uninfected Core subjects only.  
 

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Schedule of Events – HIV-infected Core Group (Subjects 6-20) and HIV-uninfected Core Group (Subjects 6-20; Days 1-99) 
(CONTINUED) 
 
Day 57 
(8 wks) 
Day 64 
(9 wks) 
Day 71 
(10 wks) 
Day 72 Day 74 Day 78 
(11 wks) 
Day 85/EOS 
(12 wks) 9 
Day 85 
(12 wks)10 
Day 99 Follow-Up 
(14 wks)9 
Day 99 EOS (14 
wks)10 
Visit window (days) 
±1 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±1 
ACTIVITIES TO BE COMPLETED BEFORE STUDY DRUG ADMINISTRATION 
Record agents in ART history 
at Screening, changes in ART 
on-study 1,9 
X 
 
X 
 
 
 
X 
 
 
 
Record results of a complete 
physical examination 
 
 
 
 
 
 
 
 
 
 
Record results of a targeted 
physical examination 2 
X 
X 
X 
 
 
X 
X 
X 
 
X 
Record vital sign 
measurements 
X 
X 
X 
 
 
X 
X 
X 
 
X 
Record the subject’s weight 
 
 
 
 
 
 
X 
 
 
X 
Record AEs 3 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
Record concomitant 
medications 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
BLOOD and/or URINE 4 SAMPLES TO BE COLLECTED 
Hematology and serum 
chemistry (see Section 7.2.1 
for list) 
X 
 
X 
 
 
 
X 
X 
 
X 
Urinalysis 
X 
 
X 
 
 
 
X 
X 
 
X 
HIV-1 RNA (viral load)9 
X 
 
X 
 
 
 
X 
 
 
 
CD4+ cell count 
 
 
 
 
 
 
X 
 
 
X 
4th Generation POC HIV-1 
test10 
X 
 
X 
 
 
 
 
 
 
X 
Serum for pregnancy test for 
females of childbearing 
potential 5 
 
 
 
 
 
 
X 
 
 
X 
Urine for pregnancy test for 
females of childbearing 
potential 
X 
 
 
 
 
 
 
 
 
 

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Day 57 
(8 wks) 
Day 64 
(9 wks) 
Day 71 
(10 wks) 
Day 72 Day 74 Day 78 
(11 wks) 
Day 85/EOS 
(12 wks) 9 
Day 85 
(12 wks)10 
Day 99 Follow-Up 
(14 wks)9 
Day 99 EOS (14 
wks)10 
Visit window (days) 
±1 
±1 
±1 
±3 hr 
±3 hr 
±1 
±1 
±1 
±1 
±1 
Antiretroviral resistance 
sample9 
X 
 
X 
 
 
 
X 
 
 
 
Archive serum sample 
X 
 
X 
 
 
 
X 
X 
 
X 
Trogarzo® serum 
concentration (pre-dose if 
drug administered on this day) 
6 
X 
 
X 
X 
X 
X 
X 
X 
 
X 
Trogarzo® serum 
concentration post-dose –  
1 hour (±10 min)  
 
 
X 
 
 
 
 
 
 
 
Immunogenicity of Trogarzo® 
(2 tubes x 3 mL each) 
 
 
 
 
 
 
X 
 
 
X 
STUDY DRUG ADMINISTRATION AND AFTER 
Administer study drug via IVI 
– study drug diluted in 250mL 
normal saline and 
administered IV over 15 
minutes per Trogarzo® 
prescribing information 
 
 
 
 
 
 
X9 
 
 
 
Administer study drug via 
IVP – undiluted Push over 
30 seconds 7 
X 
 
X 
 
 
 
 
 
 
 
Observe subject post-
administration – 15 minutes if 
HIV-infected, 60 minutes if 
uninfected; record vital sign 
measurements after 
completion of infusion and 
again at end of observation 
period8 
X 
 
X 
 
 
 
X 
 
 
 
1 All ART for the 3 months preceding Screening will be recorded at Screening visit; subsequent visits will only record changes to ART. 
2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system. 
3 Only record Aes that are related to study procedures before administration of the first dose. 

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4 Subjects need not fast before blood sampling. 
5 Serum FSH test to be conducted on postmenopausal females at Screening only. 
6  Pre-dose samples to be collected within 1 hour before the start of the infusion; 24 hr, 72, hr, and 7 Day post dose samples to be collected within 3 hours of the time 
the infusion ended. 
7 At Days 57 and 71 Core Group subjects will receive study drug as 800 mg undiluted Trogarzo® administered by IV push over 30 seconds once every 2 weeks.  At 
Day 85/EOS (12 weeks) HIV-infected subjects in the Core Group will revert to receiving 800 mg Trogarzo® diluted into 250 mL normal saline as an IV infusion 
over 15 minutes, per Trogarzo® prescribing information All subjects must be observed after the completion of each study drug administration – 15 minutes if 
HIV-infected, 60 minutes if uninfected. Vital signs should be monitored and recorded at the beginning and end of the observation period. 
8 Any abnormalities observed need to be recorded on the AE CRF.  
9 HIV-infected Core subjects only. 
10 HIV-uninfected Core subjects only.  
 
 
 
 

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Table 4 
Schedule of Events for IM Group (HIV-Infected and HIV-Uninfected Subjects) 
Day Screen* 
1 
BL 3 8 11 15 17 22 25 29 43 57 59 64 67 71 73 78 81 
85 
11 
9912 
113 
F/U10 
Week 
NA 
0 
1 1 2 2 
3 
3 3 4 6 8 
8 
9 
9 
10 10 11 11 
12 
14 
16 
Visit window (days) 
(-28 days) NA 
±3 
hr ±1 ±1 ±1 
±3 
hr ±1 ±1 ±1 ±1 ±1 
±3 
hr ±1r ±1 ±1 
±3 
hr ±1 ±1 ±1 
±1 
±1 
ACTIVITIES TO BE COMPLETED BEFORE STUDY DRUG ADMINISTRATION 
Review/discuss Inclusion/Exclusion criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Obtain signed Informed Consent Form 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record demographics, medical history (general and HIV); height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record agents in ART history at Screening, changes in ART on-
study1 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X9 
 
 
Record results of a complete physical examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Record results of a targeted physical examination 2 
 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X10 
 
Record vital sign measurements 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X10 
 
Record the patient’s weight 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X9 
X10 
 
Record AEs 3 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X 
X 
Assess injection site 
 
 
 
 
 
 
 
 
 
X X X 
X 
X 
X 
X 
X X X 
X 
 
 
Record concomitant medications 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
 
 
HIV Treatment Satisfaction Questionnaire (HIVTSQs) 
 
 
 
 
 
 
 
 
 X9 
 
 
 
 
 
 
 
 
 
X9 
 
 
HIV Treatment Satisfaction Questionnaire (HIVTSQc) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X9 
 
 
Study Medication Satisfaction Questionnaire (SMSQs) 
 
 
 
 
 
 
 
 
 X10  
 
 
 
 
 
 
 
 
X10 
 
 
Study Medication Satisfaction Questionnaire (SMSQc) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X10 
 
 
BLOOD and/or URINE SAMPLES TO BE COLLECTED 
Hematology and serum chemistry (see Section 7.2.1 for list) 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X10 
 
Urinalysis 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X10 
 
HIV-1 RNA (viral load)9 
X 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
 
 
4th Generation POC HIV test10 
 
X 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
X 
 
 
 
 
X 
 
CD4+ cell count  
X 
X 
 
 
 
 
 
 
 
X 
 
X 
 
 
 
 
 
 
 
X9 
X10 
 
Serum for pregnancy test for females of childbearing potential5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X9 
X10 
 
Urine for pregnancy test for females of childbearing potential 
 
X 
 
 
 X10 
 
 
 
X X10 X 
 
 
 
X10 
 
 
 
 
 
 
Antiretroviral resistance sample9 
 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
 
 
Archive serum sample 
 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X 
X10 
 
Trogarzo® serum concentration (pre-dose if drug administered 
on this day)6,13 
 
X X X X X X X X X X X 
X 
X 
X 
X 
X X X 
X 
X10 
 

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Day Screen* 
1 
BL 3 8 11 15 17 22 25 29 43 57 59 64 67 71 73 78 81 
85 
11 
9912 
113 
F/U10 
Week 
NA 
0 
1 1 2 2 
3 
3 3 4 6 8 
8 
9 
9 
10 10 11 11 
12 
14 
16 
Visit window (days) 
(-28 days) NA 
±3 
hr ±1 ±1 ±1 
±3 
hr ±1 ±1 ±1 ±1 ±1 
±3 
hr ±1r ±1 ±1 
±3 
hr ±1 ±1 ±1 
±1 
±1 
Immunogenicity of Trogarzo® (2 tubes x 3 mL each) 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X9 
X10 
 
STUDY DRUG ADMINISTRATION AND AFTER 
Administer study drug via IVI – study drug diluted in 250 mL 
normal saline and administered IV over 15 minutes per 
Trogarzo® prescribing information 
 
X 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X9 
 
 
Administer study drug via IM injection7 
 
 
 
 
 
 
 
 
 
X X X 
 
 
 
X 
 
 
 
 
 
 
Observe subject for 15 minutes if HIV infected and 60 minutes if 
HIV uninfected after administration; record vital sign 
measurements after dose administration and again at end of 
observation period8 
 
X 
 
 
 
X 
 
 
 
X X X 
 
 
 
X 
 
 
 
X9 
 
 
*  Screening visit to be conducted for HIV-infected patients ONLY.  See Table 2 for Screening and Pre-Steady State Phase Schedule of Events 
1 All prior ART will be recorded at Screening; subsequent visits will only record changes to ART.  
2 Abbreviated physical examination includes examination of lymph nodes, respiratory and cardiovascular systems, abdomen, extremities, and nervous system.  
3 Only record AEs that are related to study procedures before administration of the first dose; after administration of first dose, assessments will include evaluation of 
injection site for reaction.  
4 Subjects need not fast before blood sampling.  
5 Serum FSH test to be conducted on postmenopausal females at Screening only.  
6 Pre-dose samples to be collected within 1 hour before the start of the infusion.  
7 At Baseline and at Day 15, subjects in the IM Group will receive study drug diluted into 250 mL normal saline as an 800 mg IV infusion over 15 minutes, per 
Trogarzo® prescribing information.  At Day 29 IM Group subjects will begin receiving study drug as 800 mg undiluted Trogarzo® administered by IM injection once 
every 2 weeks. 
8 Any abnormalities observed need to be recorded on the AE case report form. 
9 HIV-infected IM group subjects only. 
10 HIV-uninfected IM subjects only. 
11 Day 85 is end of study for HIV-infected subjects. 
12 Day 99 is follow-up for HIV-infected subjects and is end of study for HIV-uninfected subjects. 
13 PK visits between Baseline and Day 29 will not be required for HIV-infected subjects participating in the IM portion of TMB-302 who have re-enrolled after 
receiving a 2000mg loading dose and one 800 mg dose of Trogarzo® by IVI prior to study re-enrollment since these PK samples will already have been collected 
during initial study participation. 
 
 

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3.5 
Safety Assessments 
Safety assessments will include the results of the following measurements through Day 99 
(14 weeks) for the Sentinel Group and the HIV-uninfected Core and IM Groups Subjects, whose 
participation is 2 weeks longer in duration, Day 85 (12 weeks) for the HIV-1 infected Core and IM 
Group subjects: 
 
◼ 
Physical examinations; 
◼ 
Vital sign measurements; 
◼ 
Clinical laboratory parameters (hematology, CD4+ T-cell counts, serum chemistry, and 
urinalysis); 
◼ 
Monitoring of Aes and concomitant medications; 
◼ 
Anti-Trogarzo® antibody levels (immunogenicity of Trogarzo®). 
◼ 
Injection site reactions in subjects receiving Trogarzo® IM 
 
3.6 
Pharmacokinetic Assessments 
Pharmacokinetic samples will be collected in the study to evaluate serum concentrations of 
Trogarzo®.  These data will be used to allow evaluation of the PK profile of Trogarzo®.  In 
particular, data will be collected to compare serum drug concentrations (AUC and trough) after IVI 
of the 800 mg diluted drug over 15 minutes to IV push of the undiluted drug over 30 seconds and 
IM injection.  Study TMB-121 results showed that following 800 mg Trogarzo® via IM injection, the 
Tmax was 2.13 days.  Therefore, for better estimation of AUC following IM injection, the timepoints 
of 2, 7, 10, and 14 days following dosing were selected.  For comparison between IV infusion of the 
800 mg diluted drug over 15 minutes and IM, blood will be collected at the same timepoints for 
both routes.  See Table 1, Table 2, Table 3, and Table 4 for PK sample collection timepoints. HIV-1 
infected participants who re-enroll after receiving a loading dose of 2000mg IVI and at least one 
maintenance dose of 800mg IVI given according to the label a minimum of 4 weeks prior to Day 1 
enrollment will not undergo PK assessments between the Baseline and Day 29 visits since these PK 
samples will already have been collected during the subject’s initial study participation. The PK 
assessments of the re-enrolled participants will be compared between the IVI from their first 
enrollment and IM from their second enrollment. 

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4. Study Treatment 
 
4.1 
Study Drug Dosage and Administration 
The first five (5) subjects enrolled will comprise the Sentinel Group.  After all subjects in the 
Sentinel Group have successfully completed Day 99 (14 weeks) of the study, and the DMC has 
reviewed the accumulated data and given approval for enrollment of the Core Group to proceed, 
subjects six (6) through twenty (20) will be enrolled.  
 
For the IV administrations (IVI and IV push), study drug will be administered intravenously via a 
23-gauge IV butterfly. Study drug should be administered in the cephalic vein of the subject’s right 
or left arm.  If this vein is not accessible, an appropriate vein located elsewhere can be used.  The 
administration site will be recorded in the source documents and CRF.  Once placed, the IV line 
should be flushed with 2-5 mL of saline to insure proper placement. Study drug administration by 
IV infusion, bolus, or push should be done as per the protocol.  Once drug administration is 
completed the line should be flushed with 2-5 mL of normal saline prior to removal of the device.  
An infusion pump (like Baxter Flo Gard 6201, Bodyguard 323 CME, or similar – not supplied by 
the Sponsor) should be employed as needed to achieve study drug administration times indicated in 
the protocol for IVI and IV bolus.  IV push dosing over 30 seconds should not be performed with a 
pump. 
 
For the IM injections, a volume of 5.32 mL, corresponding to 800 mg Trogarzo®, will be 
administered over two injections of about 2.66 mL each.  The two IM injections should be 
administered in the muscle tissue of the subject’s anterolateral aspect of the thighs (left, right, or 
both).  The two IM injections are to be administered in one body area and injection sites should be 
at least 1 inch apart.  If an alternative body area is necessary for subject comfort/convenience, IM 
injections can be administered in the dorsogluteal site (upper outer quadrant of the buttock).  Every 
effort should be made to limit injection sites to one body area for each dose, if possible.  The 
injection site must be examined at baseline and described in detail for subsequent exam.  This 
information will be recorded. 
 
After sterilization of the injection site with an alcohol swab, the study drug will be injected using a 
syringe with a needle of appropriate gauge and length into the IM tissue. Injection site, body mass 

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index (BMI), needle gauge and length used will be collected in the eCRF.  In brief, skin at the 
injection site will be stretched firmly and the study drug will be injected slowly into muscle tissue at a 
90-degree angle. 
 
All Subjects at Day 1/Baseline and Day 15 
At the Day 1/Baseline and Day 15 visits, all subjects in the study will receive a maintenance dose of 
800 mg Trogarzo® diluted in 250 mL normal saline (at 3.2 mg/mL) and administered as an IVI over 
15 minutes in accordance with the approved Trogarzo® prescribing information.  
 
Sentinel Group (Subjects 1 to 5) at Day 29 (4 weeks) through Day 85 (12 weeks) 
Beginning at Day 29 and continuing through Day 85 (12 weeks), the 800 mg maintenance doses of 
Trogarzo® will be administered in the Sentinel Group at sequentially increasing concentrations and 
over sequentially reduced time periods in accordance with the study schedule (see Section 3.1 and 
Table 1).  The sequential changes in the dilution and dosing rate in the Sentinel Group is as follows: 
 
◼ 
Day 29 (4 weeks): 800 mg diluted in 50 mL normal saline (at 16 mg/mL) via IVI over 
10 minutes 
◼ 
Day 43 (6 weeks): 800 mg diluted in 16 mL normal saline (at 50 mg/mL) via IV bolus over 
5 minutes 
◼ 
Day 57 (8 weeks): 800 mg diluted in 8 mL normal saline (at 100 mg/mL) via IV bolus over 
1 minute 
◼ 
Day 71 (10 weeks): 800 mg undiluted (at 150 mg/mL) via IV push over 30 seconds 
◼ 
Day 85 (12 weeks): 800 mg undiluted (at 150 mg/mL) via IV push over 30 seconds 
When five (5) subjects in the Sentinel Group have completed Day 99 (14 weeks) of the study, the 
DMC will review the available data to determine whether the enrollment of the Core Group should 
proceed.  
 
Core Group (Subjects 6 to 20) at Day 29 (4 weeks) through Day 71 (10 weeks) 
After DMC review of data from the Sentinel Group and approval obtained for the study to proceed, 
the Core Group (subject numbers six (6) through twenty [20]) will be enrolled.  Beginning at Day 29 
and continuing through Day 71 (10 weeks), subjects in the Core Group will receive an 800 mg 
maintenance dose q2wk as undiluted drug over 30 seconds. 
 

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In HIV-infected individuals, at Day 99 (14 weeks) for the Sentinel Group, and at Day 85 (12 weeks) 
for the Core Group, subjects will revert to receiving Trogarzo® as a diluted IVI over 15 minutes in 
accordance with the prescribing information. 
 
In HIV-uninfected individuals Trogarzo® will be discontinued after the Day 71 IV push.  
 
At Day 113 (16 weeks) for the Sentinel Group, and Day 99 (14 weeks) for the Core Group, only 
safety follow-up is performed.  These visits may be performed via telephone if evaluation does not 
require a clinic visit, and subjects should return to routine administration of Trogarzo® through their 
primary care provider at this time point. 
 
IM Group (Subjects 21-40) at Day 29 (4 weeks) through Day 71 (10 weeks) 
Subjects in the IM Group will receive the first two doses of study drug in accordance with the 
Trogarzo® prescribing information (diluted in normal saline and administered over 15 minutes via 
IVI).  The next four doses will be administered as an IM injection.  At Day 85 (12 weeks), IM Group 
HIV-infected subjects will revert to diluted IVI dosing over 15 minutes in accordance with the 
Trogarzo® prescribing information. 
In HIV-uninfected individuals Trogarzo® will be discontinued after the Day 71 injection.  
 
Subjects will be followed for safety through 28 days after the last Trogarzo® administration on study 
(from Day 85 [12 weeks] through Day 113 [16 weeks] for the Sentinel and HIV-infected IM Groups, 
from Day 71 [10 weeks] through Day 99 [14 weeks] for HIV-uninfected Core and IM Groups , and 
at Day 99 for the HIV-infected Core Group).  Safety follow-up visits may be performed via 
telephone if evaluation does not require a clinic visit, and subjects should return to routine 
administration of Trogarzo® through their primary care provider at this time point. 
 
All subjects will be observed after completion of each study drug administration – 15 minutes if 
HIV-infected, 60 minutes if HIV-uninfected.  In addition to noting any general acute reactions, the 
site of injection will be inspected, and any unusual signs noted.  Vital signs will be recorded 
immediately after completion of study drug administration and again at the end of the observation 
period.  All AEs occurring during observation will be recorded. 
 

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4.2 
Prohibited Medications and Restrictions 
Use of and changes in concomitant medications will be recorded in the subject’s source documents 
and the electronic data capture (EDC) system.  All prescription drugs, herbal products, vitamins, 
minerals, and over-the-counter medications are to be recorded. 
 
Any concomitant medication with the exception of those listed below may be given at the discretion 
of the investigator.  However, the investigator has the responsibility of ensuring that details 
regarding the concomitant medication are recorded for the subject in the EDC system.  Complete 
information is expected for any medication prescribed during the trial. 
 
The prescribing information for all medications, including Trogarzo® should be reviewed carefully.  
The guidance provided in the respective contraindications, warning, and precautions section for any 
medication must be followed to prevent any potentially serious or life-threatening drug interactions. 
Refer to the current Trogarzo® Package Insert and/or Investigator Brochure and/or Product 
Monograph for relevant information. 
 
The following medications are not to be administered concomitantly in HIV-infected individuals: 
 
◼ 
Any vaccines other than influenza or COVID vaccine during the 7 days before 
Day 1/Baseline through EOS; 
◼ 
All investigational drugs from 30 days before Day 1/Baseline through EOS, with the 
exception of investigational components of a qualifying stable ART regimen 
In HIV-uninfected subjects vaccines may be administered during the course of the study with 
approval by the study staff; however, no investigational drugs may be administered. 
 
4.3 
Safety Monitoring and Toxicity Management Plan 
Sentinel Group 
This trial will employ a sentinel group of 5 subjects to determine the safety of progressively 
shortening the administration time while increasing the drug concentration of Trogarzo® with the 
goal of delivering an 800 mg dose (5.32 mL at 150 mg/mL) via IV push over 30 seconds. 
A dose-limiting toxicity (DLT) will be defined as: 

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• Any Grade 3 or greater toxicity that the study investigators recognize as probably or 
definitely attributable to Trogarzo® administration. Grade 3 and 4 laboratory abnormalities 
must be confirmed by a repeat test obtained as soon as possible following the initial result 
OR 
• Any subject with Grade 2 infusion-related reaction and/or cytokine release syndrome (see 
Appendix B – DAIDS Grading Table V2.1 for cytokine release syndrome). 
The first 2 subjects in the Sentinel Group will be enrolled and treated at least 2 weeks prior 
to the enrollment and treatment of the remaining 3 subjects.  
If no DLT occurs within 7 days of Trogarzo® shortened IV infusion, bolus, or push administration 
then dosing of additional subjects may continue with approval of the DMC. 
If 1 DLT occurs within 7 days of Trogarzo® dosing at a shortened IV infusion, bolus, or push 
administration then the DMC should be notified; however, dosing may continue. The individual 
experiencing the DLT should resume dosing as per current FDA-approved administration 
instructions and the subject will discontinue from the study.  
If 2 DLTs occur within 7 days of Trogarzo® dosing at a shortened IV infusion, bolus, or push 
administration then such administration should be suspended and further dosing of Trogarzo® 
should resume as per current FDA-approved administration instructions.  
Any SAE deemed related to the change in administration time and concentration of Trogarzo® in 
any participant in the Sentinel Group will result in cessation of dosing at increased concentration 
and over intervals <15 minutes. The DMC should review the event and all scheduled Trogarzo® 
dosing should resume as per current FDA-approved administration instructions to avoid loss of 
virologic control. The DMC may recommend resumption of the Sentinel Group dosing schedule 
after review of the SAE. 
 
Core Group 
Once the Sentinel group has completed Day 99 and the DMC has reviewed the safety data and 
approved additional enrolment and treatment with Trogarzo® given as an IV push over 30 seconds, 
the Core Group may begin enrolment and dosing as per the study design. 
The Core Group will consist of 15 subjects who will receive an 800 mg maintenance dose of 
Trogarzo® in accordance with the prescribing information (diluted in normal saline and administered 
over 15 minutes via IVI) at Day 1/Baseline and again at Day 15.  Every 2 weeks thereafter through 

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Day 71 (10 weeks), maintenance doses will be administered via undiluted IV push over 30 seconds.  
At Day 85 (12 weeks), HIV-infected Core Group subjects will revert to diluted IVI dosing over 
15 minutes in accordance with the Trogarzo® prescribing information.  HIV-uninfected Core Group 
subjects will discontinue dosing after the Day 71 study drug administration.  
As above, a DLT will be defined as any Grade 3 or greater toxicity that the study investigators 
recognize as probably or definitely attributable to Trogarzo® administration. Grade 3 and 4 
laboratory abnormalities must be confirmed by a repeat test obtained as soon as possible following 
the initial result. 
In the absence of the occurrence of DLTs, the DMC should formally review all safety data at the 
following timepoints: 
1. After 5 subjects in the Core Group receive 2 doses of Trogarzo® IV push (IVP) over 
30 seconds. 
2. After the first 5 subjects in the Core Group receive 4 doses of Trogarzo® IV push over 
30 seconds and the second 5 subjects receive 2 doses of Trogarzo® IVP over 30 seconds. 
3. At the conclusion of the study of all 15 Core Group subjects. 
For HIV-uninfected healthy volunteers: 
If 1 DLT occurs within 7 days of a subject receiving Trogarzo® by IVI or IV push over 30 seconds, 
then the DMC should be notified, and dosing of additional Core Group subjects may continue.  
However, the individual experiencing the DLT should discontinue dosing and be observed for 28 
days prior to study discontinuation.  
If 2 DLTs occur within 7 days of a subject receiving Trogarzo® by IVI  or by IV push over 
30  seconds, then the DMC should be notified; however, dosing of additional HIV-1 infected Core 
Group subjects may continue. The individuals experiencing the DLT should discontinue dosing and 
be observed for 28 days prior to study discontinuation.  The DMC should at this point review. 
If 3 DLTs occur within 7 days of a subject receiving Trogarzo® by IVI or IV push over 30 seconds, 
then the DMC should be notified, and further dosing of Core Group subjects should be suspended.  
All Core Group subjects should resume dosing as per current FDA-approved administration 
instructions.  
For HIV-1 infected individuals: 
If 1 DLT occurs within 7 days of a subject receiving Trogarzo® IV push over 30 seconds, then the 
DMC should be notified, and dosing of additional Core Group subjects may continue.  However, 

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the individual experiencing the DLT should resume dosing as per current FDA-approved 
administration instructions and the subject will discontinue from the study.  
If 2 DLTs occur within 7 days of a subject receiving Trogarzo® IV push over 30 seconds, then the 
DMC should be notified; however, dosing of additional Core Group subjects may continue.  The 
individuals experiencing the DLT should resume dosing as per current FDA-approved 
administration instructions and the subjects will discontinue from the study.  
If 3 DLTs occur within 7 days of a subject receiving Trogarzo® IV push over 30 seconds, then the 
DMC should be notified, and further dosing of Core Group subjects should be suspended.  All Core 
Group subjects should resume dosing as per current FDA-approved administration instructions.  
Any SAE deemed related to study drug administration will result in cessation of dosing by IV push 
over 30 seconds.  The DMC should review the event and all Trogarzo® dosing should resume as per 
current FDA-approved administration instructions to avoid loss of virologic control.  The DMC will 
determine whether dosing by IV push over 30 seconds may resume in additional participants. 
 
IM Group 
The IM Group will consist of approximately 20 subjects who will receive the first four doses of 
study drug in accordance with the Trogarzo® prescribing information (diluted in normal saline and 
administered over 15 minutes via IVI).  The next four doses will be administered as an IM injection.  
HIV-infected IM Group subjects will revert to diluted IVI dosing over 15 minutes in accordance 
with the Trogarzo® prescribing information at Day 85 (Week 12). 
As above, a DLT will be defined as any Grade 3 or greater toxicity that the study investigators 
recognize as probably or definitely attributable to Trogarzo® administration.  Grade 3 and 4 
laboratory abnormalities must be confirmed by a repeat test obtained as soon as possible following 
the initial result. 
In the absence of the occurrence of DLTs, the DMC should formally review all safety data at the 
following time-points: 
1. After 5 subjects in the IM Group receive 2 doses of Trogarzo® via IM injections 
2. After the first 5 subjects (subjects 1-5) in the IM Group receive 4 doses of Trogarzo® via IM 
injections and the second 5 subjects (subjects 6-10) receive 2 doses of Trogarzo® via IM 
injections 
3. At the conclusion of the study of all 20 IM Group subjects 
 

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For HIV-uninfected healthy volunteers: 
If 1 DLT occurs within 7 days of a subject receiving Trogarzo® by IVI or IM injection, then the 
DMC should be notified, and dosing of additional IM Group subjects may continue.  However, the 
individual experiencing the DLT should discontinue dosing and be observed for 28 days prior to 
study discontinuation.  
If 2 DLTs occur within 7 days of a subject receiving Trogarzo® by IVI or by IM injection then the 
DMC should be notified; however, dosing of additional HIV-1 uninfected IM Group subjects may 
continue.  The individuals experiencing the DLT should discontinue dosing and be observed for 
28 days prior to study discontinuation.  The DMC should at this point review. 
If 3 DLTs occur within 7 days of a subject receiving Trogarzo® by IVI or by IM injection, then the 
DMC should be notified, and further dosing of IM Group subjects should be suspended.  All IM 
Group subjects should resume dosing as per current FDA-approved administration instructions.  
For HIV-infected individuals: 
If 1 DLT occurs within 7 days of a subject receiving Trogarzo® via IM injection, then the DMC 
should be notified, and dosing of additional IM Group subjects may continue.  However, the 
individual experiencing the DLT should resume dosing as per current FDA-approved administration 
instructions and the subject will discontinue from the study.  
If 2 DLTs occur within 14 days of a subject receiving Trogarzo® via IM injection, then the DMC 
should be notified; however, dosing of additional IM Group subjects may continue.  The individuals 
experiencing the DLT should resume dosing as per current FDA-approved administration 
instructions and the subjects will discontinue from the study.  
If 3 DLTs occur within 14 days of a subject receiving Trogarzo® via IM injection, then the DMC 
should be notified, and further dosing of IM Group subjects should be suspended.  All IM Group 
subjects should resume dosing as per current FDA-approved administration instructions.  
Any SAE deemed related to study drug administration will result in cessation of dosing via IM 
injection.  The DMC should review the event and all Trogarzo® dosing should resume as per current 
FDA-approved administration instructions to avoid loss of virologic control.  The DMC will 
determine whether dosing by IM injection may resume in additional participants. 
Refer to Appendix C for further information on the management of suspected anaphylactoid 
reactions. Study drug should only be administered in a setting that allows for rapid access to 
emergency cardiopulmonary support services in the event of a life-threatening infusion-related AE 
(e.g., anaphylaxis). 

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4.4 
Study Stopping Rules 
In consultation with the DMC: 
• Any 2 DLTs in the Sentinel Group that the DMC confirms to be probably or definitely due 
to the administration of Trogarzo® at a faster rate or increased concentration or both 
• Any 2 DLTs in the HIV-uninfected volunteers in the Core Group occurring within 7 days of 
treatment that the DMC confirms to be probably or definitely due to the administration of 
Trogarzo® by IVI, IV push, or IM will result in the discontinuation of enrollment of HIV-
uninfected healthy volunteers.  HIV-uninfected volunteers already enrolled in the study may 
complete the trial if they do not meet these DLT criteria.  
• Any 3 DLTs in the Core IVP or IM Groups that the DMC confirms to be probably or 
definitely due to the administration of Trogarzo® at a faster rate or increased concentration 
or both 
• Any SAE in any Group that the DMC confirms to be probably or definitely due to the 
administration of Trogarzo® at a faster rate or increased concentration or both 
 
4.5 
Study Drug Description 
HIV-infected study participants will be treated with commercially packaged Trogarzo® according to 
the instructions for infusion in the approved prescribing information both prior to and after 
completion of this study.  HIV-uninfected healthy volunteers will be treated with drug packaged and 
labeled for clinical research use provided to study sites by the study sponsor.  
To prevent potential loss of benefits and disruption of drug availability to the HIV-infected 
participants, study drug will be obtained at the clinical sites using the same means for obtaining the 
commercial drug employed for that subject prior to study entry and after study completion.  Thus, 
investigators will be asked to apply labels to the TMB-302 study drug as required for an 
Investigational New Drug Application (IND) study utilizing labels and procedures provided by the 
Sponsor or Designee.  
Trogarzo® is a single-use parenteral formulation contained in a 2 mL, clear-glass vial, and packaged 
into cartons containing 2 vials each.  The drug product contains ibalizumab-uiyk at a concentration 
of 150 mg/mL, histidine United States Pharmacopoeia (USP), sucrose, sodium chloride, polysorbate 
80, and water for injection USP at pH 6.0.  Each vial contains at least 1.33~ mL of fluid delivering a 

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total of 200 mg study drug per vial.  Each 800 mg dose of study drug will thus require 4 vials 
(2 cartons for HIV-infected and 4 cartons for HIV-uninfected due to differences in packaging) of 
Trogarzo®.  The stability of Trogarzo® at 2ºC to 8ºC is evaluated in ongoing studies.  For any period 
of storage, Trogarzo® must be under refrigerated conditions with a temperature-monitoring device. 
Trogarzo® should be maintained at 2°C to 8°C (but NOT FROZEN) and protected from light in 
accordance with Trogarzo® packaging information.  
Any spent vials or remaining contents of used vials should be destroyed according to the site’s 
procedures for spent vial destruction and disposal only after complete drug accountability records 
have been reviewed and accepted during routine monitoring, and written permission has been given 
for spent vial destruction.  The destruction should be documented. 
 
4.6 
Study Drug Accountability 
The investigator will maintain accurate records of all study drug, including when, how much, and 
condition under which the study drug is received, dispensed, and destroyed by site personnel.  In 
addition, the administration of study drug to each subject should be documented to the vial level for 
each infusion (i.e., lot number of every vial for that infusion, expiration date, time of infusion 
preparation, time and duration of administration, and documentation of full infusion received). 
Reasons for deviation from the expected dispensing regimen must also be recorded.  Drug 
accountability will be reviewed and documented at each study monitoring visit.  Reconciliation and 
accountability of study drug will be done throughout the study during the monitoring visits.  The 
Sponsor or designee shall maintain written records of all drug dispositions, which will include the 
name of the investigator, the date, quantity, batch or code of each such shipment, and method of 
disposal.  Disposal may only occur after complete drug accountability records have been reviewed 
and accepted during routine monitoring, and written permission has been given for used vial 
destruction. 
 
5. Subject Enrollment 
 
Approximately 40 subjects will be enrolled into the study at approximately 7-8 sites in the United 
States.  Approximately twenty subjects will receive Trogarzo® via an IV push and approximately 20 
subjects will receive Trogarzo® via IM injection.  Subjects will be enrolled only if they meet all of the 
inclusion criteria and none of the exclusion criteria. 
 

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5.1 
Inclusion Criteria 
HIV-infected participants:  
 
Subjects must meet all of the following criteria to be included in the study: 
 
1. 
Are capable of understanding and have voluntarily signed the informed consent 
document 
2. 
Currently receiving a stable Trogarzo®-containing ARV regimen for a minimum of 
3 months, and no change in background ARVs anticipated over the period of study 
participation; a stable regimen is defined as having no changes in dose or frequency and 
no interruptions ≥2 weeks during the 3-month period 
o Note: For subjects who receive Trogarzo® as an IV push (Core Group) and then 
enter the study to receive Trogarzo® as an IM injection (IM Group), the period while 
receiving the IV push will be considered as having received a stable Trogarzo®-
containing ARV regimen. 
o Note: HIV-infected subjects who are enrolled in the IM injection study and are 
unable to adhere to the study schedule for IM dosing due to factors outside the study 
will be discontinued. Re-enrollment of HIV-infected IM Group subjects will be 
allowed after a Discontinuation Visit and Screening Visit are completed provided 
that inclusion/exclusion criteria continue to be satisfied and dosing after 
discontinuation is resumed according to the Trogarzo® Prescribing Information.  
For re-enrolling subjects, the inclusion criteria for stable a Trogarzo®-containing 
ARV regimen is satisfied with a loading dose of 2000mg IVI and at least one 
maintenance dose of 800mg IVI given according to Trogarzo® labeling prior to Day 
1 enrollment. 
 
3. 
Have no AIDS-defining events in the 3 months before Screening, other than cutaneous 
Kaposi's sarcoma or wasting syndrome due to HIV. 
4. 
Are able and willing to comply with all protocol requirements and procedures 
5. 
Are 18 years of age or older 
6. 
Have a life expectancy that is >6 months 
7. 
Have a viral load <1,000 copies/mL at Screening 
8. 
CD4+ T-cell count >50 cells/mm3 at Screening 

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9. 
Prothrombin time (PT) and partial thromboplastin time (PTT) <1.5 times the upper 
limit of normal (IM Group only) 
HIV-uninfected individuals: 
1. 
Healthy volunteers born male and female as assessed by medical history and physical 
examination 
2. 
Aged >18 and <50 years at the time of Screening 
3. 
Ability and willingness to provide written informed consent 
4. 
Willingness to comply with protocol schedule 
5. 
Willingness to undergo HIV-1 testing 
6. 
Non-reactive 4th generation point of care HIV-1 test at Screening 
7. 
Hepatitis B Surface antigen negative 
8. 
Hepatitis C antibody negative, or if reactive, Hepatitis C RNA undetectable in plasma 
9. 
PT and PTT <1.5 times the upper limit of normal (IM Group only) 
10. 
Volunteers born female of reproductive potential who are sexually active with a male 
sex partner must agree to use one effective method of contraception from the time of 
signing the consent to completion of the study and agree to pregnancy testing as per the 
schedule of events. 
Volunteers born female with reproductive potential are defined as pre-menopausal 
volunteers born female who have not had a sterilization procedure (e.g., hysterectomy, 
bilateral oophorectomy, tubal ligation or salpingectomy).  Volunteers born female are 
considered menopausal if they have not had a menses for at least 12 months and have a 
follicle-stimulating hormone (FSH) of greater than 40 IU/L or if FSH testing is not 
available, they have had amenorrhea for 24 consecutive months. 
 
5.2 
Exclusion Criteria 
HIV-infected participants:  
Subjects having or meeting any of the following conditions or characteristics will be excluded from 
the study: 
 

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1. 
Any active AIDS-defining illness according to the Centers for Disease Control and 
Prevention (CDC) Revised Surveillance Case Definitions for HIV Infection 2008 
(Morbidity and Mortality Weekly Report (MMWR) Vol.57/No. RR-10, Appendix A), or 
history of the same during the 3 months preceding Screening, with the following 
exceptions: cutaneous Kaposi's sarcoma and wasting syndrome due to HIV 
2. 
Any significant diseases (other than HIV-1 infection) or clinically significant findings, 
including psychiatric and behavioral problems, determined from Screening, medical 
history, and/or physical examination that, in the investigator’s opinion, would preclude the 
subject from participating in this study 
3. 
Any significant acute illness within 1 week before the initial administration of study drug 
4. 
Any active infection secondary to HIV requiring acute therapy; however, subjects that 
require maintenance therapy (i.e., secondary prophylaxis for opportunistic infections) will 
be eligible for the study 
5. 
Any immunomodulating therapy (including interferon), systemic steroids, or systemic 
chemotherapy within 12 weeks before Enrollment 
6. 
Any vaccination within 7 days before Day 1 
7. 
Any female subject who either is pregnant, intends to become pregnant, or is currently 
breastfeeding 
8. 
Any current alcohol or illicit drug use that, in the investigator’s opinion, will interfere with 
the subject’s ability to comply with the study schedule and protocol evaluations 
9. 
Any radiation therapy during the 28 days before first administration of study medication 
10. 
Any Grade 3 or 4 laboratory abnormality according to the Division of AIDS (DAIDS) 
grading scale, except for the following asymptomatic Grade 3 events: 
➢ triglyceride elevation 
➢ total cholesterol elevation 
➢ or Grade 3 or 4 reductions in levels of CD4+ T cells 
11. 
History of coagulopathy that would preclude administration of IM injections (IM Group 
only) 
12. 
Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site 
reactions (IM Group only) 
13. 
Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamole or other 
antiplatelet medication that would interfere with the ability to receive IM injections (IM 
Group only). 
 
HIV-uninfected individuals 

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1. 
Confirmed HIV-1 infection 
2. 
At high risk of severe COVID-19 disease as defined by one of the following: 
• History of hypertension, atherosclerotic cardiovascular disease (ASCVD), 
coronary artery disease, diabetes mellitus 
• History of asthma or chronic pulmonary disease 
• History of renal disease and chronic renal insufficiency 
• BMI over 35 
3. 
Any acute or chronic medical condition that in the opinion of the investigator would 
preclude participation 
4. 
Chronic autoimmune disease 
5. 
Active IV drug use 
6. 
Excessive use of alcohol or recreational drugs that in the opinion of the investigator 
would preclude participation 
7. 
Decompensated psychiatric illness 
8. 
Need for chronic immunotherapy including systemic corticosteroids, other MAb 
therapy, or immunosuppressive drugs 
9. 
Volunteers born female who are pregnant, lactating, or planning on becoming pregnant 
over the study period 
10. 
Any of the following laboratory parameters: 
• Hemoglobin <10.0 g/dL 
• Absolute neutrophil count <1,000/mm3 
• Absolute lymphocyte count <500/mm3 
• Platelet count <100,000/mm3 
• Creatinine >1.25x upper limit of normal (ULN) 
• Aspartate aminotransferase (AST) >1.5x ULN 
• Alanine aminotransferase (ALT) >1.5x ULN 
• Glucose (non-fasting) >160 mg/dL 
• Proteinuria: 2+ or greater 
• Hematuria: >10 red blood cells (RBCs) per high-power field 

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11. 
Previous receipt of an experimental MAb for HIV-1treatment or prevention in a 
research study 
12. 
History of severe allergic reactions to drugs, vaccines, or drug infusion 
13. 
Participation in another investigational clinical trial within the past 12 weeks or 
anticipated during the course of the current study 
14. 
History of coagulopathy that would preclude administration of IM injections (IM 
Group only) 
15. 
Skin rashes or tattoos that would prevent ability to assess IM injection for injection-site 
reactions (IM Group only) 
16. 
Use of high-dose aspirin, clopidogrel, prasugrel, ticagrelor, dipyridamoleor any other 
antiplatelet medication that would interfere with the ability to receive IM injections (IM 
Group only). 
5.3 
Subject Withdrawal and Discontinuation 
5.3.1 
Reasons for Withdrawal or Discontinuation 
A subject may be withdrawn or discontinued from the study if: 
 
◼ 
The subject withdraws consent to participate or requests an early discontinuation at any 
time during the study 
◼ 
The subject is in violation of the protocol 
◼ 
The subject becomes pregnant during the study (Section 8.7 for a description of 
procedures to be followed in case of pregnancy) 
◼ 
The subject experiences a severe drug-related AE during study drug administration or 
during the post-administration observation period 
◼ 
Upon determination by the investigator that withdrawal from the study is in the best 
interests of the subject 
◼ 
Any HIV-uninfected subject in the Core Group who tests positive for HIV-1 during the 
course of the study will be withdrawn. 
◼ 
Refer to Sections 6.1, 6.2, and 6.3 for additional reasons for study discontinuation 

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Refer to Sections 4.3 and 4.4 for detailed information on the Safety Monitoring and Toxicity 
Management Plan and the Study Stopping Rules. 
 
A subject experiencing one or more treatment-emergent SAEs will receive treatment and follow-up 
evaluations by the investigator, or they will be referred to another appropriate physician for 
treatment and follow-up.  Withdrawal from the study will be at the discretion of the 
investigator/Sponsor. 
 
The investigator will also withdraw a subject upon the request of the DMC (Section 8.8) or if the 
Sponsor or local regulatory agency (e.g., FDA) terminates the study.  Upon occurrence of an SAE, 
the Investigator will notify the Sponsor or designee via the SAE hotline of these events (Section 
8.6).  If a subject is discontinued because of an AE, the event will be followed until satisfactory 
resolution or until the investigator deems the event to be chronic or the subject to be stable. 
 
5.3.2 
Handling of Withdrawals and Discontinuations 
Subjects are free to withdraw from the study at any time upon request. Subject participation in the 
trial may be stopped at any time at the discretion of the investigator or at the request of the Sponsor 
or designee.  At the time of withdrawal or discontinuation, the investigator will assess the best 
options for treatment and discuss these options with the subject. 
 
If a subject in the study is discontinued due to any reason other than safety as detailed in Section 4.3 
(Safety Monitoring and Toxicity Management), another subject may be enrolled.  
 
HIV-infected subjects who are enrolled in the IM injection study and are unable to adhere to the 
study schedule for IM dosing due to factors outside the study will be discontinued. Re-enrollment of 
HIV-infected IM Group subjects will be allowed after a Discontinuation Visit and Screening Visit 
are completed provided that inclusion/exclusion criteria continue to be satisfied and dosing after 
discontinuation is resumed according to the Trogarzo® Prescribing Information.  For re-enrolling 
subjects, the inclusion criteria for stable a Trogarzo®-containing ARV regimen is satisfied with a 
loading dose of 2000mg IVI and at least one maintenance dose of 800mg IVI given according to 
Trogarzo® labeling prior to Day 1 enrollment. 
 
When a subject withdraws or is discontinued from the study, the reason(s) for withdrawal or 
discontinuation will be recorded by the investigator.  Whenever possible, all subjects who withdraw, 

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or are discontinued from the study prematurely will undergo all safety assessments and follow-up 
procedures as described for Day 99 (14 weeks) and Day 113 (16 weeks) for the Sentinel and HIV-
infected IM Groups, and for Day 85 (12 weeks) and Day 99 (14 weeks) for the HIV-1 infected Core 
Group and the HIV-uninfected IM Group, respectively, and Day 99 for the HIV-uninfected Core 
Group subjects, with the exception of re-enrolled HIV-infected subjects participating in the IM 
study.  Subjects who fail to return for final assessments will be contacted by the site personnel in an 
attempt to have the subjects comply with the protocol.  A minimum of two documented phone calls 
should be made over the course of at least 2 weeks.  If the site personnel receive no response, they 
should send a certified letter requesting that the subject contact the site regarding his or her status in 
the study.  If the subject does not respond at this point, the date the certified letter was mailed will 
be considered the date of study withdrawal. 
 
In the event of a subject death during the study, the date of death (as listed on the death certificate) 
will be used for the date of study discontinuation. 
 
It is vital to obtain follow-up data on any subject withdrawn because of an AE or SAE. In such 
cases, the subject will be followed to satisfactory resolution or until the investigator deems the event 
to be chronic or the subject to be stable.  In any case, every effort must be made to undertake 
protocol-specified safety follow-up procedures. 
 
5.3.3 
Sponsor or Regulatory Agency Termination of Study 
Although the Sponsor intends to complete the study, the right is reserved to discontinue the study at 
any time for clinical or administrative reasons, or if required by the local regulatory authority (e.g., 
FDA).  If the Sponsor discontinues the study, FDA will be notified promptly. 
 
6. Study Visits 
 
Subjects will complete all Screening procedures as detailed in the Schedule of Events (see Table 1, 
Table 2, Table 3, and Table 4). Successful Screening results will allow the subjects to proceed to the 
Day 1/Baseline visit.  
 

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6.1 
Sentinel Group 
Study drug administration visits will take place once every 2 weeks beginning at Day 1/Baseline and 
continuing through Day 99 (14 weeks).  After the study drug administration at Day 85 (12 weeks) by 
IV push, Sentinel Group subjects will revert to routine administration of Trogarzo® diluted in 
250 mL normal saline via IVI over 15 minutes in accordance with Trogarzo® prescribing 
information.  The scheduled visit at Day 113 (16 weeks) is for safety follow-up only, and this visit 
may be conducted by telephone if no clinic visit is needed for this purpose.  Trogarzo® 
administration at Day 113/follow-up should be conducted in the routine manner as employed prior 
to the study, through the primary care provider.  
 
Safety assessments, including collection of blood and urine specimens for safety laboratory testing, 
as well as HIV-1 viral load and archive and viral resistance samples, will be conducted every 2 weeks 
beginning at Day 1/Baseline and continuing through Day 99 (14 weeks).  Additionally, beginning at 
Day 29 (4 weeks), Sentinel Group subjects will also have non-laboratory safety assessments (vital 
signs, AEs, recording of concomitant medications) during visits on intervening weeks between the 
study drug administrations that are less than 15 minutes in duration (e.g., at Day 36 [5 weeks], 
Day 50 [7 weeks], Day 64 [9 weeks], etc.), through Day 92 (13 weeks).  
 
Pharmacokinetic samples will be collected after the study drug doses at Day 1/Baseline, Day 15 
(2 weeks), Day 71 (10 weeks), and Day 85 (12 weeks) at the following timepoints: 1 hour, 24 hours, 
72 hours, 7 days, and 14 days after study drug administration.  This schedule will require additional 
visits solely for sample collection on Study Days 2, 4, 8, 16, 18, 22, 72, 74, 86, 88, and 92. 
Pharmacokinetic samples will also be collected on Days 1, 15, 29, 43, 57, 71, 78, 85, and 99 when 
visits are otherwise scheduled, and extra visits are not needed on these days for collection of these 
samples.  The 1-hour, 24-hour, and 14-day post-dose serum concentration data are required for 
estimation of the PK AUC. 
Study participants who 
1. miss 2 consecutive visits or  
2. have more than one treatment visit out of window or 
3. have 3 non-treatment visits over 4 weeks that are out of window 
will be discontinued from the study and may be replaced.  For this reason, it is important to enroll 
only participants who in the judgement of the investigator are likely to be compliant with the study 
visit and sample collection schedule. 

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A complete physical examination will be conducted at Screening.  Targeted physical exams will be 
conducted at designated visit from Day 1 through Day 99 (14 weeks).  Weight will be recorded at 
Screening and again at Day 99 (14 weeks).  Immunogenicity samples will be collected at 
Day 1/Baseline and again at Day 99 (14 weeks).  Sentinel Group subjects will be asked to return for 
the final study assessments indicated for the EOS and Follow-up visits at Days 99 (14 weeks) and 
113 (16 weeks), respectively.  Subjects who are discontinued or who withdraw from the study 
prematurely are also requested to complete the assessments for these 2 study visits. Refer to the 
Schedule of Events tables for details on procedures for each scheduled study visit and for PK 
sampling timepoints (for the Sentinel Group, see Table 1). 
 
6.2 
Core Group 
Study drug administration visits will take place once every 2 weeks beginning at Day 1/Baseline and 
continuing through Day 85 (12 weeks).  After the study drug administration at Day 71 (10 weeks), 
HIV-infected Core Group subjects will revert to routine administration of Trogarzo® diluted in 
250 mL normal saline via IVI over 15 minutes in accordance with the Trogarzo® prescribing 
information.  HIV-uninfected subjects will discontinue dosing after the Day 71 study drug 
administration.  The scheduled visit at Day 99 (14 weeks) for the HIV-infected Core Group subjects 
is for safety follow-up only, and this visit may be conducted by telephone if no clinic visit is needed 
for this purpose.  Trogarzo® administration at Day 99/follow-up should be conducted in the routine 
manner as employed prior to the study, through the primary care provider.  The Day 99 EOS visit in 
the HIV-uninfected Core group subjects that is 28 days after the last dose of Trogarzo® must be 
completed in the clinic. 
 
HIV-uninfected participants will have additional visits as per Table 2 and Table 3.  HIV-uninfected 
subjects will receive a 2000 mg infusion over 60 minutes on Day -55 followed by 3 doses of 800 mg 
infusion over 15 minutes on Days - 41, -27, and Day -13.  Safety assessments including collection of 
blood and urine specimens for safety laboratory testing will be conducted every 4 weeks beginning 
on Day -55 and will continue through Day 1 at which time the Schedule of Events will be identical 
to that of the HIV-infected Core subjects. 
 
On Day 1 HIV-1 uninfected subjects will enter the Treatment Study Phase.  These HIV-uninfected 
subjects will receive an 800 mg dose of Trogarzo® in accordance with the prescribing information 
(diluted in 250 mL normal saline and administered over 15 minutes via IVI) at Day 1/Baseline and 

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again at Day 15.  Every 2 weeks thereafter through Day 71 (10 weeks), subsequent doses will be 
administered via undiluted IV push over 30 seconds.  After the Day 71 infusion (10 weeks), 
HIV-uninfected Core Group subjects will discontinue Trogarzo® infusion therapy.    
 
Safety assessments, including collection of blood and urine specimens for safety laboratory testing, 
as well as HIV-1 viral load and archive and viral resistance samples (HIV-infected subjects only), will 
be conducted every 2 weeks beginning at Day 1/Baseline and continuing through Day 85 (12 weeks) 
for HIV-infected subjects, and through Day 99 for HIV-uninfected healthy volunteers.  In addition, 
beginning at Day 29 (4 weeks), Core Group subjects will also have non-laboratory safety 
assessments (vital signs, AEs, recording of concomitant medications) conducted during visits on 
intervening weeks between the IV push study drug administrations (e.g., at Days 36 [5 weeks], 50 
[7 weeks], 64 [9 weeks], etc.), through Day 78 (11 weeks) for HIV-infected subjects, and through 
Day 85 (12 weeks) for HIV-uninfected healthy volunteers.  
 
Pharmacokinetic samples will be collected after study drug doses at Day1/Baseline, Day 15 
(2 weeks), Day 43 (6 weeks), and Day 85 (12 weeks) at the following timepoints: 1 hour, 24 hours, 
72 hours, 7 days, and 14 days after study drug administration.  This schedule will require additional 
visits solely for sample collection on Study Days 2, 4, 8, 16, 18, 22, 44, 46, 72, and 74. 
Pharmacokinetic samples will also be collected on Days 1, 15, 29, 43, 50, 57, 71, 78, and 85 when 
visit are otherwise scheduled and extra visits are not needed on these days for collection of these 
samples.  The 1-hour, 24-hour, and 14-day post-dose serum concentration data are required for 
estimation of the PK AUC.  In HIV-1 uninfected subjects PK samples will also be drawn on 
Days -55, -41, -27, and -13.  
 
Study participants who: 
1. miss 2 consecutive visits or  
2. have more than one treatment visit out of window or  
3. have 3 non-treatment visits over 4 weeks that are out of window 
will be discontinued from the study and may be replaced.  For this reason, it is important to enroll 
only participants who in the judgement of the investigator are likely to be compliant with the study 
visit and sample collection schedule.  
 
A complete physical examination will be conducted at Screening.  Targeted physical exams will be 
conducted at designated visits from Day 1 through Day 85 (12 weeks) for HIV-infected and through 
Day 99/EOS (14 weeks) for HIV-uninfected healthy volunteers.  In addition, HIV-1 uninfected 

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individuals will undergo targeted physical exams on study Days -55, -41, -27, and -13.  Weight will be 
recorded at Screening and again at Day 85 (12 weeks) for HIV-infected subjects, and at 
Day 99/EOS (14 weeks) for HIV-uninfected healthy volunteers.  Immunogenicity samples will be 
collected at Day 1/Baseline and again at Day 85 (12 weeks) for HIV-infected subjects or 
Day 99/EOS (14 weeks) for HIV-uninfected healthy volunteers.  
 
Core Group subjects will be asked to return for the final study assessments indicated for the EOS 
and Follow-up visits at Days 85 (12 weeks) for HIV-infected subjects and 99 (14 weeks) for 
HIV-uninfected healthy volunteers.  Subjects who are discontinued or who withdraw from the study 
prematurely are also requested to complete the assessments for these 2 study visits.  Refer to the 
Schedule of Events tables for details on procedures for each scheduled study visit and for PK 
sampling timepoints (for the Core Group, see Table 3). 
 
6.3 
IM Group  
HIV-infected subjects in the IM Group will receive the first two doses of study drug in accordance 
with the Trogarzo® prescribing information (diluted in normal saline and administered over 
15 minutes via IVI) at Day 1/Baseline and again at Day 15.  The next four doses of Trogarzo® will 
be administered as an IM injection.  At Day 85 (12 weeks), IM Group HIV-infected subjects will 
revert to diluted IVI dosing over 15 minutes in accordance with the Trogarzo® prescribing 
information.  
 
HIV-uninfected individuals will receive four doses of Trogarzo® (pre-Steady State Phase) as 
described above for Core Group HIV-uninfected individuals prior to the Study Treatment Phase.  
In the Study Treatment Phase, HIV-uninfected subjects will receive the first two doses of Trogarzo® 
in accordance with the prescribing information (diluted in 250 mL normal saline and administered 
over 15 minutes via IVI) at Day 1/Baseline and again at Day 15.  The next four doses of Trogarzo® 
will be administered as an IM injection.   
 
HIV-uninfected subjects will discontinue dosing after the Day 71 study drug administration.  The 
scheduled visit at Day 113 (16 weeks) for the HIV-uninfected IM Group subjects is for safety 
follow-up only, and this visit may be conducted by telephone if no clinic visit is needed for this 
purpose.  Trogarzo® administration at Day 99/follow-up should be conducted in the routine manner 
as employed prior to the study, through the primary care provider.  The Day 99 EOS visit in the 

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HIV-uninfected IM group subjects that is 28 days after the last dose of Trogarzo® must be 
completed in the clinic. 
 
Safety assessments, including collection of blood and urine specimens for safety laboratory testing, 
as well as HIV-1 viral load and archive and viral resistance samples (HIV-infected individuals only), 
will be conducted every 2 weeks beginning at Day 1/Baseline and continuing through Day 85 
[12 weeks]) for HIV-infected subjects, and through Day 99 for HIV-uninfected healthy volunteers.  
In addition, subjects will also have non-laboratory safety assessments (vital signs, recording of 
concomitant medications, assessment of IM injection site) conducted during visits on intervening 
weeks between the study IM drug administrations through the EOS.  AEs are collected at all 
timepoints from time of consent. 
 
Targeted physical examinations will be conducted at various visits from Day 1 through Day 85 
(12 weeks) for HIV-infected subjects, and through Day 99 for HIV-uninfected healthy volunteers. 
Weight will be recorded at Screening and again at EOS.  Immunogenicity samples will be collected 
at Day 1/Baseline and again at EOS (Day 85 [12 weeks] for HIV-infected subjects or Day 99 
[14 weeks] for HIV-uninfected healthy volunteers).  IM Group subjects will be asked to return for 
the final study assessments indicated for the EOS and Follow-up visits (Day 99 [14 weeks] for 
HIV-infected and Day 113 [16 weeks] for HIV-uninfected see Table 4).  Subjects who are 
discontinued or who withdraw from the study prematurely are also requested to complete the 
assessments for these two study visits, unless they are re-enrolled HIV-infected individuals  
participating in the IM study.  
 
Pharmacokinetic samples will be collected after study drug doses at Day 1/Baseline and Days 15, 57, 
and 71 at the following timepoints: 48 hours, and 7, 10, and 14 days after study drug administration).  
This schedule will require additional visits solely for sample collection on Study Days 3, 8, 11, 17, 22, 
25, 59, 64, 67, 73, 78, and 81.  For IM dosing, the 2- and 14-day post-dose serum concentration data 
are required for the estimation of PK AUC.  
Discontinued HIV-1 infected participants who re-enroll after receiving a loading dose of 2000mg 
IVI and at least one maintenance dose of 800mg IVI given according to the label prior to Day 1 
enrollment will not undergo PK assessments between Baseline and the Day 29 visits since these PK 
samples will already have been collected during the subject’s initial study participation. The PK 
assessments of the re-enrolled participants will be compared between the IVI from their first 
enrollment and IM from their second enrollment. 

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In HIV-1 uninfected subjects PK samples will also be drawn on Days -55, -41, -27, and -13.  
 
Study participants who: 
1. miss 2 consecutive visits or  
2. have more than one treatment visit out of window or  
3. have 3 non-treatment visits over 4 weeks that are out of window 
will be discontinued from the study and may be replaced.  For this reason, it is important to enroll 
only participants who in the judgement of the investigator are likely to be compliant with the study 
visit and sample collection schedule. However, discontinued HIV-1 subjects in the IM portion of 
the study may rescreen and re-enroll in the event of the need for a loading dose with 2000mg IVI of 
Trogarzo® followed by at least one maintenance dose of 800 mg IVI and with agreement to adhere 
to the subsequent study schedule. 
 
Refer to Table 4 for details on procedures for each scheduled study visit and for PK sampling 
timepoints. 
 
6.4 
Follow-up Visits: Day 113 (Sentinel Group and HIV-
Uninfected IM Group) / Day 99 (Core and HIV-infected IM 
Groups)  
All subjects are to have a Follow-up Visit - at Day 113 (16 weeks) for the Sentinel and HIV-
uninfected IM Groups, and at Day 99 (14 weeks) for the Core and HIV-infected IM Groups for 
collection of safety information.  The medications taken during the follow-up period (the period 
from the previous scheduled study visit – Day 99 [14 weeks] for the Sentinel and HIV-uninfected 
IM Groups, Day 85 [12 weeks] for the Core and HIV-infected IM Groups through to this 
Follow-Up Visit) should be captured as concomitant medications in the EDC system.  Any changes 
to background ARV medications should also be recorded, along with a reason for the change.  AEs 
will be collected at this visit.  If it is not necessary for the subject to present at the clinic for these 
procedures, this visit may be conducted via telephone.  Administration of Trogarzo® for this visit 
should be conducted in the routine manner as employed prior to the study, through the primary care 
provider. 
 
Subjects that withdraw or are discontinued from either study group should be followed for 28 days 
after receiving administration of study drug either by IV infusion, bolus, push, or IM, except for 
discontinued HIV-infected IM subjects that are re-enrolling into the study. 

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6.5 
Early Withdrawal Procedures 
Subjects who withdraw or are discontinued from the study at any time before EOS (Day 85 (12 
weeks) for HIV-infected Core or IM Groups, or Day 99 for Sentinel and HIV-uninfected Core or 
IM Groups) will be asked to complete all EOS procedures to ensure safety and to collect as much 
study data as possible, except for discontinued HIV-infected IM subjects that are re-enrolling into 
the study.  These individuals should be followed for 28 days after receiving study drug 
administration.   
 
6.6 
Unscheduled Visits 
Unscheduled visits are allowed for the following reasons: 
 
◼ 
To perform confirmatory laboratory testing for clinically abnormal values; and 
◼ 
Any time the investigator feels that it is clinically required for safety reasons related to 
the subject’s participation in this trial. 
Findings during these unscheduled visits must be reported in the EDC system under the 
unscheduled visit section. 
 
7. Study Assessments 
 
A central laboratory will analyze all blood and urine samples with the exception of the HIV-1 
resistance testing, immunogenicity testing, and PK assessments, which will be undertaken by 
appropriate specialty contract laboratories.  Urine samples will be analyzed at the site; if abnormal 
results are obtained for a subject, a urine sample will be sent to the central laboratory for 
microscopic evaluation. 
 
The following assessments will be conducted at the times indicated in the Schedules of Events 
(Table 1, Table 2, Table 3, and Table 4). 
 

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7.1 
Activities to be Completed 
7.1.1 
Demographic Data, Medical History, and Concomitant Medications 
Demographic data, a complete medical history (per subject report), and documentation of prior 
medications will be collected at Screening; information about recent or concomitant medications will 
be obtained at each visit.  
 
7.1.2 
Complete Physical Examination 
A complete physical examination will include the following assessments: skin, head, eyes, ears, nose, 
throat (“HEENT”), chest including breasts and lungs, heart, abdomen, extremities and neurological 
exam.  Height and weight will be measured at Screening and weight only at other times specified. 
 
7.1.3 
Targeted Physical Examination 
A targeted physical examination will be limited to assessment of HEENT, chest, heart, abdomen 
and assessment of any site related to specific signs and symptoms reported by the subject. 
 
7.1.4 
Vital Sign Measurements 
Vital sign measurements will include the subject’s heart rate (beats/minute), blood pressure (mm 
Hg), respiratory rate (breaths/minute), and oral temperature (ºC).  Measurements will be taken 
within 1 hour before the start of the study drug administration and again at both the beginning and 
end of the 15 minute (HIV-infected) or 60 minute (HIV-uninfected) post-administration 
observation period.  Blood pressure and heart rate measurements will be obtained after the subject 
has been seated for at least 5 minutes.  Ideally, each subject’s blood pressure should be measured 
using the same arm and the same size cuff at each visit. 
 
7.1.5 
 Patient Reported Outcomes 
Participants in the IM Group will be asked to complete questionnaires to assess their satisfaction 
with the different modes of Trogarzo® administration.  The questionnaires will be administered at 
various visits (see Table 4).  The Study Medication Satisfaction Questionnaire change version 
(SMSQc) is a self-reported assessment tool to assess the amount of change in treatment satisfaction 

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over time.  The questionnaire was adapted from the HIV Treatment Satisfaction Questionnaire 
(HIVTSQ) to remove mentions of HIV and allow satisfaction evaluation in participants who do not 
have HIV (see Appendix D).7,8,9,10,11,12  HIV-infected participants in the IM Group will complete the 
HIVTSQ status version (HIVTSQs12) at Day 29 regarding IVI administration and at Day 85 
regarding IM administration. In addition, they will also complete the change version of the 
questionnaire (HIVTSQc12) following completion of the IM portion of the study (Day 85).  HIV-
uninfected participants will complete the SMSQ status version (SMSQs) at Day 29 regarding IVI 
administration and at Day 85 regarding IM administration.  In addition, they will also complete the 
change version of the questionnaire (SMSQc) following completion of the IM portion of the study 
(Day 85).  Instructions and questionnaires are provided in Appendix D. 
• HIV-infected IM Group Participants: 
o HIVTSQs12: questionnaire to be completed on  D29 and D85 
o HIVTSQc12:  questionnaire to be completed on D85 
• HIV-Uninfected IM Group Participants: 
o SMSQs: questionnaire to be completed on D29 and D85 
o SMSQc: questionnaire to be completed on D85 
• Preference assessment (Day 85): “For the past 8 weeks you have received IM injections 
every 2 weeks.  Today we would like you to compare your experience on the IM injections 
with the IV infusion you received previously during this study.  Which type of administration 
do you prefer?”. 
 
7.2 
Blood and Urine Samples 
7.2.1 
Clinical Laboratory Parameters 
Collection of blood and urine samples for clinical laboratory assessments will be part of the safety 
profile assessment for the study subjects.  Subjects do not need to fast before blood sampling.  
Samples will be processed using standard procedures as described in the laboratory procedures 
manual and will be analyzed by a central laboratory unless otherwise noted. 
 
The samples will be analyzed for the following: 
 
◼ 
Hematology: complete white blood cell count with differential, hemoglobin, 
hematocrit, and platelets.  Prothrombin time and partial thromboplastin time will also 
be collected at Screening only for the IM group. 

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◼ 
Serum chemistry profile: albumin, alkaline phosphatase, ALT, amylase, AST, blood 
urea nitrogen, calcium, chloride, creatine phosphokinase, creatinine, direct bilirubin, 
gamma glutamyl transferase, glucose, lactate dehydrogenase, magnesium, phosphorus, 
potassium, sodium, total bilirubin, total protein, and uric acid. 
◼ 
Urinalysis: visual inspection for appearance and dipstick assessment for color, pH, 
specific gravity, ketones, protein, glucose, bilirubin, nitrite, urobilinogen, and leukocyte 
esterase. 
The urinalysis will be performed at the site by qualified personnel.  If the results of the urinalysis are 
abnormal, a urine sample will be sent to the central laboratory for microscopic evaluation.  Samples 
will be processed as described in the laboratory procedures manual before being sent to the central 
laboratory for evaluation. 
 
Tests with Grade 3 or Grade 4 abnormal results should be repeated within 72 hours of the site 
becoming aware of the abnormal value(s) with the exception of CD4+ T cell levels.  See 
Appendix B for details and definitions of toxicities.  The investigator should discuss any Grade 3 or 
4 abnormal laboratory results with the medical monitor/Sponsor for appropriate subject disposition, 
including potential withdrawal from the study.  Refer to Section 4.3 (Safety Monitoring and Toxicity 
Management Plan) for information on DMC reporting and subject discontinuation in the event of 
study drug–related AEs. 
 
7.2.2 
Archive Sample 
A separate blood sample will be taken and stored for possible research use. 
 
7.2.3 
HIV-1 Viral Resistance Testing 
Blood samples for HIV-1 viral resistance testing should be collected before the start of drug 
administration at the indicated visits in HIV-infected subjects only. Viral resistance testing will be 
conducted if a subject experiences an increase in plasma viral load to levels above 1,000 copies/mL 
on 2 consecutive measurements at least 2 weeks apart.  Resistance testing will include assessments of 
reverse transcriptase, protease, integrase, and envelope genes and chemokine coreceptor utilization; 
the samples will be collected and stored. 
 

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7.2.4 
HIV-1 RNA Level 
Blood samples for viral load will be collected at Screening, Day 1, and at several additional 
timepoints through the study and used to determine study qualification as well as the effectiveness 
of the study regimens and should be drawn before drug administration in HIV-1 infected subjects 
only. 
 
7.2.5 
CD4+ Cell Count 
Blood samples for CD4+ cell count will be collected at Screening, Day 1, and at several additional 
time points during the study to determine study qualification as well as how well the immune system 
is functioning.  
 
7.2.6 
Immunogenicity of Trogarzo® 
Blood samples will be collected to test for the development of antibodies against Trogarzo® during 
the study, including Day -55 in HIV-uninfected Core and IM subjects, Day 1/Baseline, and at EOS 
(Day 99 [14 weeks] for Sentinel Group, Day 85 [12 weeks]/Day 99 [14 weeks] for Core and IM 
Groups).  Samples will be collected prior to Trogarzo® administration on those days.  The incidence 
of anti-Trogarzo® antibody production will be determined using an enzyme-linked immunosorbent 
assay (ELISA) that has been validated for the detection of anti-Trogarzo® antibodies in human 
serum even if circulating drug is present.  
 
7.2.7 
Trogarzo® Serum Concentrations 
Measurements of Trogarzo® serum concentrations will be conducted to determine the 
concentration-time profile of Trogarzo® in all subjects.  Trogarzo® serum concentrations will be 
measured using a validated ELISA with a lower limit of quantitation (LLOQ) at 0.010 μg/mL. 
 
7.2.8 
Serum Follicle-Stimulating Hormone Testing 
A serum FSH test will be performed on postmenopausal females at Screening (See Section 8.7).  The 
level of FSH should exceed 40 IU/L for the subject to be considered postmenopausal.  If the 
subject does not meet this criterion, she must agree to use proper birth control precautions as 

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described in Section 8.7 and must have serum and urine pregnancy tests throughout the protocol at 
times specified in the Schedules of Events. 
 
7.2.9 
Pregnancy Testing 
A serum pregnancy test will be performed at Screening and at EOS (Day 99 [14 weeks] for the 
Sentinel Group, Day 85 [12 weeks]/Day 99 [14 weeks] for the Core and IM Groups) for all females 
of childbearing potential.  A urine pregnancy test will be performed at defined subsequent study 
visits to confirm that a female has not become pregnant during the study.  These tests are performed 
for the protection and safety of the fetus, as the risk to the fetus is unknown.  Any subject who 
becomes pregnant during the study will be withdrawn from the study.  See Section 8.7 for a 
description of procedures to be followed in case of pregnancy. 
 
7.2.10 
4th Generation Point of Care HIV-1 Testing 
All HIV-1 uninfected healthy subjects will be tested at Screening and Day -55 and during the course 
of the study as outlined in Table 2, Table 3, and Table 4 with a 4th generation point of care HIV test 
using blood collected at the visit.  If a test is reactive, then blood should be sent to the Central lab 
for confirmatory HIV-1 testing which includes testing for HIV-1 by nucleic acid amplification 
(NAAT) and a serologic response to HIV-1 (Geenius HIV1/2 Biorad). 
 
7.2.11 
Hepatitis B Surface Antigen and Hepatitis C Antibody Testing 
All HIV-1 uninfected healthy volunteer candidates will be tested at Screening for Hepatitis B Surface 
Antigen and Hepatitis C Antibody.  If a sample is Hepatitis C Antibody reactive, a reflex Hepatitis C 
RNA quantitation will be performed.  
 
8. Adverse Events 
 
8.1 
Definitions 
Per the FDA regulations in 21 CFR (Code of Federal Regulations) 312.32, the following definitions 
apply to this protocol: 
 
Adverse Events. An AE is defined as any untoward medical occurrence associated with the use of a 
drug in humans, whether or not considered drug related. 

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Adverse Reaction. Any adverse event caused by a drug or its experimental administration. 
 
Treatment-Emergent AEs. A treatment-emergent AE is defined as any event not present before 
exposure to study drug or its experimental administration or any event already present that worsens 
in either intensity or frequency following exposure to the experimental administration of study drug. 
 
Serious Adverse Event or Serious Suspected Adverse Reaction. An adverse event or suspected 
adverse reaction is considered ‘‘serious’’ if, in the view of either the investigator or sponsor, it results 
in any of the following outcomes: death, a life-threatening adverse event, inpatient  hospitalization 
or prolongation of existing hospitalization, a persistent or significant incapacity or substantial 
disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.  
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize the 
subject or subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in this definition. 
 
Suspected Adverse Reaction. A suspected adverse reaction means any AE for which there is a 
reasonable possibility that the drug or its experimental administration caused the AE.  For the 
purposes of IND safety reporting, “reasonable possibility” means there is evidence to suggest a 
causal relationship between the drug or its experimental administration and the AE. 
 
Unexpected Adverse Event or Unexpected Adverse Reaction. An AE or adverse reaction that 
is not listed in the investigator’s brochure or is not listed at the specificity or severity that has been 
observed. 
 
The Common Terminology Criteria for AEs (CTCAE) v. 5.0 scale will be used for assessment of 
any infusion reactions, or anaphylactic events (see Section 8.5).  The DAIDS: Table for Grading the 
Severity of Adult and Pediatric AEs Version 2.1 will be used for assessment of all other AEs (see 
Appendix B). 
 
8.2 
Eliciting Adverse Event Information 
At every study visit, subjects will be asked a standard, nondirective question, such as “How have you 
been feeling since your last visit?” to elicit any medically related changes in their well-being.  They 

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will also be asked if they have been hospitalized, had any accidents, used any new medications, or 
changed concomitant medication regimens (both prescription and over-the-counter medications). 
 
In addition to subject self-report, AEs will be documented from clinically significant findings 
resulting from abnormal laboratory test values, physical examination findings, or from other 
documents that are relevant to subject safety.  
 
8.3 
Reporting Adverse Events 
The investigator is responsible for reporting to the Sponsor or designee all AEs that are observed or 
reported by the subject during the study (from the time the subject signs informed consent until 
28 days after the last dose of the administration of study drug is given whether by IV infusion, bolus, 
or push or IM injection), regardless of their relationship to study drug or its experimental 
administration or their clinical significance.  Subjects will be instructed to contact study site 
personnel at any time after informed consent if any symptoms develop.  AEs will be documented in 
the subject’s source documents and recorded in the AE section of the EDC system. 
 
To ensure compliance with FDA regulations (21 Code of Federal Regulations [CFR] 312.64), site 
investigators must report immediately all AEs that meet the SAE criteria, regardless of presumed 
relationship to the study drug or its experimental administration, to the Sponsor.  The Sponsor will 
carefully review the SAE information to monitor the study drug’s toxicity profile and subject safety.  
If any event meets the FDA’s reporting criteria, it will be submitted to the FDA as an IND Safety 
Report (21 CFR 312.32). 
 
All AEs reported or observed during the study must be recorded in detail in the AE section of the 
EDC system and followed to a satisfactory resolution or until the investigator deems the event to be 
chronic or the subject to be stable. 
 
Information to be collected includes the event term, date of onset, date of resolution, 
investigator-specified assessment of severity and relationship to study drug or its experimental 
administration, and seriousness, as well as any required treatment or evaluations and outcome. 
 
Pre-existing conditions (present before the start of the AE collection period) are considered 
concurrent medical conditions and should NOT be recorded as AEs.  However, if the pre-existing 
condition worsens in severity, the investigator must report is as an AE. 

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Each AE should be recorded to represent a single diagnosis. Accompanying signs (including 
abnormal laboratory values) or symptoms should NOT be recorded as additional AEs.  If a 
diagnosis is unknown, sign(s) or symptom(s) should be recorded as an AE(s).  Changes in laboratory 
values are only considered to be AEs if they are judged to be clinically significant (i.e., if some action 
or intervention is required or if the investigator judges the change to be beyond the range of normal 
physiological fluctuation).  If abnormal laboratory values findings are the result of pathology for 
which there is an overall diagnosis (e.g., increased creatinine in renal failure), the diagnosis only 
should be recorded as an AE. 
 
Pre-planned procedures (surgeries or therapies) that were scheduled prior to the start of AE 
collection are not considered AEs.  However, if a pre-planned procedure is performed early (e.g., as 
an emergency) due to a worsening of the preexisting condition, the worsening of the condition 
should be captured as an AE.  Elective procedures performed where there is no change in the 
subject’s medical condition should not be recorded as AEs but should be documented in the 
subject’s source documents. 
 
Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization Drug 
Dictionary (WHODD) will be used to code all AEs and classify all medicines, respectively.  All 
coding will be performed by Westat and reviewed and approved by the medical monitor. 
 
All AEs, whether serious or not, should be followed to a satisfactory resolution or until the 
Investigator deems the event to be chronic or the subject to be stable and the AE is determined to 
be not clinically significant. 
 
8.4 
Assessment of Causality 
The investigator’s assessment of an AE's relationship to study drug or its experimental 
administration is part of the documentation process, but it is not a factor in determining what is or is 
not reported in the study.  If there is any doubt as to whether a clinical observation is an AE, the 
event should be reported. 
 
The relationship or association of the study drug or its experimental administration in causing or 
contributing to the AE will be characterized by the investigator using the following classifications 
and criteria from 21 CFR 312.32: 

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Suspected Adverse Reaction. This relationship applies to any adverse event for which there is a 
reasonable possibility that the drug or its experimental administration caused the adverse event.  For 
the purposes of IND safety reporting, "reasonable possibility" means there is evidence to suggest a 
causal relationship between the drug or its experimental administration and the adverse event.  
Suspected Adverse Reaction implies a lesser degree of certainty about causality than adverse 
reaction, which means any adverse event caused by a drug. 
 
Unrelated. This relationship suggests that there is no association between the study drug and the 
reported event. To be deemed unrelated, an alternative etiology must be present. 
 
8.5 
Assessment of Severity 
The intensity of the AE will be rated by the investigator as mild, moderate, severe, or potentially 
life-threatening using the following criteria: 
 
Mild (Grade 1): Symptoms causing no or minimal interference with usual social and functional 
activities. 
 
Moderate (Grade 2): Symptoms causing greater than minimal interference with usual social and 
functional activities. 
 
Severe (Grade 3): Symptoms causing inability to perform usual social and functional activities. 
 
Potentially Life-Threatening (Grade 4): Symptoms causing inability to perform basic self-care 
functions OR medical or operative intervention indicated to prevent permanent impairment, 
persistent disability, or death. 
 

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For infusion reaction, the following assessment of severity per the CTCAE toxicity table should be used: 
 
CTCAE 
Term 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 
5 
Infusion 
Related 
Reaction 
Mild transient reaction; infusion 
interruption not indicated; 
intervention not indicated 
Therapy or infusion interruption 
indicated but responds promptly 
to symptomatic treatment (e.g., 
antihistamines, NSAIDS, 
narcotics, IV fluids); prophylactic 
medications indicated for=≤24 hrs 
Prolonged (e.g., not rapidly 
responsive to symptomatic 
medication and/or brief 
interruption of infusion); 
recurrence of symptoms following 
initial improvement; 
hospitalization indicated for 
clinical sequelae 
Life-threatening consequences; 
urgent intervention indicated 
Death 
Definition: A disorder characterized by adverse reaction to the infusion of pharmacological or biological substances. 
Anaphylaxis 
- 
- 
Symptomatic bronchospasm, with 
or without urticaria; parenteral 
intervention indicated; allergy-
related edema/angioedema; 
hypotension 
Life-threatening consequences; 
urgent intervention indicated 
Death 
Definition: A disorder characterized by an acute inflammatory reaction resulting from the release of histamine and histamine-like substances from mast cells, causing a 
hypersensitivity immune response. Clinically, it presents with breathing difficulty, dizziness, hypotension, cyanosis, and loss of consciousness and may lead to death. 
 
 

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For Cytokine Release Syndrome and all other AEs the DAIDS toxicity table should be followed.   
The DAIDS AE Grading Table v2.1 (July 2017) (Appendix B) will be used to grade AEs.  Changes 
in the severity of an AE should be documented to allow an assessment of the duration of the event 
at each level of intensity to be performed.  AEs characterized as intermittent require documentation 
of onset and duration of each episode. 
 
8.6 
Serious Adverse Event Reporting 
Any AE considered serious by the investigator according to the previously described criteria must be 
reported using the Westat SAE Report Form and submitted to the Westat Regulatory Affairs (RA) 
Department via FAX or email within 24 hours of the site becoming aware of the event.  Site staff 
must alert Westat of incoming safety information via the Westat SAE Hotline, either prior to or 
immediately after faxing/emailing the SAE Form. 
 
SAE Hotline:  888-464-5246 
SAE Fax: 
888-865-1983 
Email:  
Regulatory@Westat.com 
 
SAE reports must be supported by source documents that are maintained by the site investigator 
and provided to the Sponsor upon request.  Key information that must be supported by source 
documents includes, but is not limited to the following: 
 
◼ 
Event term 
◼ 
Onset date 
◼ 
Event chronology and management 
◼ 
Pertinent work-up 
◼ 
Investigator assessment of the relatedness of the event to the study drug 
◼ 
Concomitant medications and past medical history 
◼ 
Changes in study drug administration, including suspension or discontinuation of the 
experimental administration of Trogarzo® 
◼ 
If judged not study drug-related or related to its experimental administration, an 
alternate etiology 

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◼ 
Outcome and outcome date 
When reporting an SAE to Westat, a thorough summary of the event should be provided, including 
copies of relevant supporting documentation.  Before submission of these documents to Westat, all 
subject identifiers must be obliterated; the documents must be labeled only with the subject’s 
identification number to safeguard the subject’s privacy. 
 
Supplemental source documentation related to the SAE may include: 
 
◼ 
Clinic and/or hospitalization records 
◼ 
Laboratory reports 
◼ 
Pathology reports 
◼ 
Surgical reports 
◼ 
Other test results, such as x-rays, lumbar punctures, and computed tomography (CT) 
scans 
◼ 
Consult notes 
◼ 
Hospital admission and discharge summary 
◼ 
Death certificate 
◼ 
Autopsy report 
When an SAE results in hospitalization or prolongation of an existing hospitalization, it is 
recommended that a copy of the hospital admission and discharge summaries and any pertinent 
laboratory or diagnostic reports are faxed to Westat as soon as they become available. 
Documentation of the cause of death (e.g., an autopsy report or death certificate) should be 
submitted to Westat when a death is reported. 
 
The investigator should report to Westat any change in the initial SAE Report information or 
additional information that becomes available after the initial SAE Report submission.  Each 
follow-up SAE Report should be numbered sequentially. 
 
All the SAE reports and supporting information received by the participating investigators will be 
promptly evaluated by the Sponsor’s Medical Monitor who will be responsible for the safety 

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monitoring of the trial and for making decisions related the regulatory reporting of pertinent safety 
information per 21 CFR 312.32, and by the DMC as detailed in Section 4.3. 
 
The Sponsor or designee will notify the FDA and all participating Investigators in an IND safety 
report about potential serious risks, from clinical trials and any other source, no later than 15 days in 
the following cases: 
• 
Serious and unexpected suspected adverse reactions, only if there is evidence to suggest a 
causal relationship between the drug or its experimental administration and the AE. 
• 
Findings from other studies, such as epidemiological studies, pooled analysis of multiple 
studies, or clinical studies, that suggest a significant risk in humans exposed to the drug. 
• 
Findings from animal or in vitro testing.  Any finding from animal or in vitro testing whether 
or not conducted by the Sponsor that suggest a significant risk in humans exposed to the drug, 
such as reports of mutagenicity, teratogenicity, or carcinogenesis or reports of organ toxicity. 
• 
Increased rate of occurrence of serious suspected adverse reactions.  Any clinically important 
increase in the rate of serious suspected adverse reactions over that listed in the protocol or IB 
must also be reported. 
 
The Sponsor or designee will notify the FDA and all participating investigators of any unexpected 
fatal or life-threatening suspected adverse reaction as soon as possible but no later than 7 calendar 
days after the initial receipt of the information.  The investigators will follow their institutional 
policies of reporting safety information to the Institutional Review Board (IRB).  They will provide 
copies of the correspondence with the ethics committee to the Sponsor or designee for filing. 
 
8.7 
Pregnancy 
Sexually active men who have partners of childbearing potential and all females of childbearing 
potential must use an effective method of birth control (e.g., oral contraceptives, double-barrier 
methods, hormonal injectable, implanted contraceptives, or vasectomy) during the study and for 
28 days after the last dose of study drug is administered. 
 
Childbearing Potential. Females of childbearing potential are female subjects who are not 
surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral 
salpingo-oophorectomy), are not postmenopausal (at least 1 year without menses), and are not 
otherwise sterile by medical evaluation.  These subjects must use an adequate form of birth control 
as determined by the investigator.  Spermicidals are considered one component of a double-barrier 

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method.  Complete abstinence from sexual intercourse will suffice without additional contraceptive 
measures.  However, it is recommended that the Investigator discuss all options with these female 
subjects and instruct that if the subject becomes sexually active, she must use appropriate 
contraceptive measures. 
 
Similarly all men who become sexually active during the study with a partner of childbearing 
potential must be instructed to use appropriate contraceptive measures. 
 
Sterile or Postmenopausal. Females who are surgically sterile or postmenopausal will also be 
eligible for the study.  Postmenopausal is defined as having had no menses for at least 12 months 
and having an FSH level above 40 IU/L for reproductive-age females.  A surgically sterile status is 
defined as having a history of bilateral tubal ligation, hysterectomy, or bilateral 
salpingo-oophorectomy. 
 
Suspected Pregnancy. During the study, all females of childbearing potential will be instructed to 
contact the investigator immediately if they suspect they might be pregnant (e.g., late or missed 
menstrual period).  Male subjects will be instructed to contact the investigator if a sexual partner 
suspects she may be pregnant. 
 
If a subject or investigator suspects that the subject may be pregnant before experimental study drug 
administration, the study drug should not be administered experimentally until the results of 
laboratory pregnancy testing are available.  If pregnancy is confirmed, the subject must not receive 
the experimental administration of Trogarzo® and must be withdrawn from the study.  HIV-infected 
participants should discuss ongoing treatment with antiretroviral therapy including Trogarzo® with 
their primary care provider.  The investigator must immediately notify the medical monitor of a 
pregnancy during experimental study drug administration and record the event on the Pregnancy 
Surveillance Form that will be provided to each site.  Protocol-required procedures for study 
discontinuation must be performed on the subject unless contraindicated by pregnancy (e.g., x-ray 
studies).  Other appropriate follow-up procedures should be considered if indicated. 
 
The investigator must follow up with a pregnant subject or the pregnant partner of any sexually 
active male subject every 4 weeks while the woman is pregnant and every 4 weeks thereafter to 
follow perinatal and neonatal outcome.  The investigator must report follow-up information 
regarding the course of the pregnancy, including perinatal and neonatal outcome on the appropriate 

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Pregnancy Surveillance Form.  Infants that result from such pregnancies should be followed for a 
minimum of 8 weeks for safety assurances. 
 
Pregnancy Surveillance Forms will be submitted to Westat RA Department via the SAE FAX line.  
The US Department of Health and Human Services encourages the reporting of all in utero 
exposures to antiretroviral agents to the Antiretroviral Pregnancy Registry (telephone 800-258-4263 
or fax 800-800-1052). 
 
8.8 
Data Monitoring Committee 
An independent DMC will review accumulated data in accordance with the Safety Monitoring and 
Toxicity Management Plan (Section 4.3) and the Study Stopping Rules (Section 4.4).  The DMC will 
make recommendations on whether or not the study may proceed with enrollment successive 
Sentinel Group subjects, and enrollment of the Core and IM Groups in accordance with the plan 
and schedule laid out in the Safety Monitoring and Toxicity Management Plan.  The DMC will also 
conduct periodic review of data upon reaching other defined study milestones (see Section 4.3).  
Recommendations will be determined by the consensus of clinical opinions of the DMC members 
relative to AEs/SAEs/early discontinuations for any heterogeneous treatment effect in subjects in 
this study. 
 
The DMC will evaluate the risk/benefit of continuation of the study and make recommendations 
regarding the continuation, modification, or termination of the trial to the Sponsor or designee 
following meetings.  The DMC will consist of at least 3 clinical experts and an independent 
statistician.  The Sponsor or designee biostatistician and the medical leader for the Trogarzo® project 
may be present at the DMC meeting open session to reply immediately to any questions of DMC 
members. 
 
DMC meeting discussions will include AEs, abnormal laboratory test results, and a trial status 
update.  Additionally, all Grade 3 and 4 AEs and SAEs will be forwarded to the DMC.  
 

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9. Statistical Considerations 
 
9.1 
General Methodology 
The data collected are intended primarily for clinical review and interpretation.  The analysis of study 
data will be primarily descriptive, with emphasis on tabular and graphical displays.  Descriptive 
statistics will be used to guide decisions as to the clinical relevance of findings.  Unless otherwise 
stated, p-values will be determined only if they appear to be warranted from the summary statistics. 
 
For continuous data, descriptive statistics will be presented as number of subjects (n), mean, 
standard deviation, median, minimum, and maximum.  For categorical data, the frequency and 
percentage of subjects in each category will be presented.  Percentages will be based on non-missing 
data unless otherwise specified. 
 
Data will be described and analyzed using the SAS System Version 9 (SAS Institute Inc., Cary, NC, 
SAS System).  Individual subject data will be presented in subject data listings. 
 
9.2 
Populations for Analysis 
9.2.1 
Intent-to-Treat Population 
The ITT population is defined as all subjects enrolled into the study.  Subject disposition will be 
based on the ITT population.  
 
9.2.2 
Safety Population 
All subjects who receive at least one partial dose of study drug will be included in the safety dataset 
for analysis (SAF) population.  Subjects will be analyzed according to the treatment they actually 
received.  The safety population will be used for the safety analyses. 
 
9.3 
Subject Disposition 
Study completion data will be summarized for all enrolled subjects.  The number and percent of 
subjects who complete treatment; discontinue study procedures prematurely; or discontinue the 

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study prematurely will be tabulated.  The primary reason for premature discontinuation of the 
experimental administration of study drug and/or discontinuation from study participation will be 
tabulated.  Any additional reason(s) for premature discontinuation of experimental study drug 
administration will also be tabulated.  A listing of all enrolled subjects will be provided. 
 
9.4 
Demographics and Baseline Characteristics 
Descriptive statistics will be presented for demographic and other baseline characteristics for the 
ITT population.  Medical history and medication history findings will be listed and summarized. 
 
9.5 
Safety Analyses 
The safety analyses will include descriptions of treatment-emergent AEs, Class C events per the 
CDC Classification System for HIV Infection, clinical laboratory test results, physical examination 
findings, vital sign results, and Trogarzo® antibody levels (immunogenicity of Trogarzo®). 
 
9.5.1 
Adverse Events 
The incidence (n and %) of AEs, SAEs, and early termination of experimental study drug 
administration or study participation due to an AE will be presented.  Additionally, AEs will be 
tabulated according to severity and relatedness categories as reported by the investigator.  AEs will 
be presented in tables organized alphabetically by Preferred Term within SOC.  Each subject will be 
counted only once for each AE reporting level. 
 
9.5.2 
Clinical Safety Laboratory Parameters 
Clinical laboratory parameters will be presented by visit.  Descriptive statistics will be used to 
summarize observed values by visit as well as the change from baseline at each visit.  Clinical 
laboratory values outside the normal ranges will be flagged in subject data listings.  Non-numeric 
data will be presented in subject data listings but will not be tabulated. 
 

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9.6 
Efficacy 
Assessment of the HIV-1 viral loads will be made as a secondary endpoint in HIV-1 infected 
subjects by comparing the mean viral load at visits when subjects received an IVI over 15 minutes to 
the weekly visits when receiving an IV push over 30 seconds or IM injections. 
 
Study subjects will be considered virologic failures if: 
 
1. Viremic subjects experience a sustained >0.5 log increase in plasma HIV-1 RNA from 
baseline  
or 
2. A sustained viral load (VL)>200 copies/mL if subject VL was <50 copies/mL at baseline  
 
that cannot be explained by intercurrent illness, a change in adherence to the background regimen, 
or unanticipated changes to the background regimen that will meet the definition of virologic failure. 
 
Sustained is defined as 2 consecutive viral load determinations at least 2 weeks apart. 
 
Exploratory statistical analyses will explore changes in HIV-1 drug sensitivity/susceptibility to 
determine relationships with Trogarzo® administration in combination with background ARVs.  
 
9.7 
Pharmacokinetic Analyses 
Serum concentrations will be used to estimate PK parameters.  PK parameters will be estimated for 
all subjects by noncompartmental analysis of the serum concentration-time data.  Missing data will 
not be imputed.  For the re-enrolled participants, the PK parameters of IVI and IM will be 
estimated from their first enrollment and second enrollment, respectively. The exposure-response 
relationship established for the review of the ibalizumab Biologics License Application (BLA) was 
based on Ctrough, rather than AUC.  Ctrough was used as an indicator of exposure and a clear trend 
between exposure and the efficacy endpoint was observed.  Therefore, Ctrough is more representative 
of efficacy for this pharmacokinetic bridging study than AUC.  A PK bridge between the IV push 
and IVI and between the IM injection and IVI is demonstrated if the proportions of subjects with 
average Ctrough equal to or exceeding the threshold of 300 ng/mL are comparable using a Fisher’s 
Exact test.  A PK bridge is also demonstrated for AUC if the 90% confidence interval of log 
transform of the ratio of the geometric means for IV push or IM injection (test product) to IVI 
(reference product) for the 40 subjects in the study is within the 80%-125% criteria.  
 

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9.8 
Sample Size and Power Considerations 
Considering the large PK variability of Trogarzo® (~70% variability for clearance (CL) based on the 
population PK model developed for the review of BLA 761065), a minimum subject number of 20 
for each type of administration (IVP or IM) is sufficient to achieve 80% power.  In addition, the 
within-subject CV% of AUC with IM (Study TMB-121) and IVI (current TMB-302 preliminary 
data) administration, are comparable.  The median within-subject CV% is 7% for IM and IVI, while 
the maximum within-subject CV% is 22%-23% for IM and IVI.  These data also support that a 
minimum subject number of 20 for each type of administration is sufficient to achieve 80% power. 
 
10. Data Handling and Quality Assurance 
 
10.1 
Electronic Case Report Forms 
An EDC system will be used to capture data electronically for this trial, meaning that all data will be 
entered in the EDC system from source documents at the investigational site.  Case report forms 
(CRFs) will be developed to be used as worksheets.  Completion of these worksheets is optional. 
 
A subject identification (ID) list will be maintained separately from the research records and will not 
be recorded or stored with the CRFs. 
 
All data must be entered in English.  The EDC system should always reflect the latest observations 
on the subjects participating in the trial. Therefore, the data are to be entered into the EDC as soon 
as possible during or after the subject’s visit.  To avoid inter-observer variability, every effort should 
be made to ensure that the same individual who made the initial baseline determinations completes 
all antiviral activity/safety evaluations.  The clinical site monitor will verify that all data entries in the 
EDC system are accurate and correct.  If some assessments have not been done, or if certain 
information is not available, not applicable, or is unknown, the investigator should indicate this in 
the EDC system. The investigator will be required to sign off on the clinical data. 
 
The Sponsor or designee will review the EDC system and evaluate the entries for completeness and 
consistency.  The clinical site monitor will compare the data captured in the EDC system with the 
source documents to ensure there are no discrepancies between critical data recorded in the EDC 
system and the source documents.  All entries, corrections, and alterations are to be made by the 

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responsible investigator or his/her designee.  The clinical site monitor cannot enter data in the EDC 
system.  Once clinical data in the EDC system have been submitted corrections to the data fields 
will be marked by an audit trail, meaning that the reason for the change, the name of the person who 
performed the change, together with time and date will be logged.  Roles and rights of the site 
personnel responsible for entering the clinical data into the EDC system will be determined in 
advance and documented on the appropriate form. 
 
If additional corrections are needed, the responsible clinical site monitor or project data manager will 
raise a query in the EDC application.  The appropriate investigational staff will answer queries sent 
to the investigator. This correspondence will be marked by an audit trail by the EDC application, 
meaning that the name of investigational staff, time and date stamp are captured for each 
interaction/revision. 
 
10.2 
Monitoring of the Study 
The purpose of clinical site monitoring is to ensure that the trial is conducted in an ethically sound 
and scientifically rigorous manner.  Specifically, sites will be carefully monitored by the Sponsor or 
designee to ensure that: (1) the rights and well-being of participants are protected; (2) data are 
complete, accurate, and verifiable; and (3) the trial is conducted in compliance with the protocol, 
applicable government regulations (e.g., FDA, Taiwan Food and Drug Administration [TFDA]), the 
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human 
Use (ICH) E6(R1): Guidelines for Good Clinical Practice, local IRB policies, and current standard 
operating procedures at the sites and Sponsor/Sponsor’s representative. 
 
The clinical site monitor, as a representative of the Sponsor, formally evaluates the accuracy and 
completeness of the data collected and assesses compliance with the relevant regulations and 
policies.  In doing so, the clinical site monitor will visit the investigator and study facility periodically, 
in addition to maintaining necessary telephone, email, or letter contact.  The clinical site monitor will 
maintain current personal knowledge of the study through observation, review of study records and 
source documentation, and discussion of the conduct of the study with the investigator and staff. 
 
Each investigator is expected to make a reasonable effort to accommodate the clinical site monitor 
when site visits are necessary.  Because this trial is utilizing an EDC system, the monitor will need to 
access the data entry computer and internet during the visit. 
 

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10.3 
Inspection of Records 
Investigators and institutions involved in the study will permit trial-related monitoring, audits, IRB 
review, and regulatory inspection(s) by providing direct access to all study records.  In the event of 
an audit, the investigator agrees to allow the Sponsor, representatives of the Sponsor, the FDA, or 
other relevant regulatory authorities access to all study records. 
 
The investigator should immediately notify the Sponsor or designee of any audits scheduled by any 
regulatory authorities and promptly forward copies of any audit reports received to the Sponsor or 
designee. 
 
10.4 
Study Record Retention 
Essential documents should be retained for at least 2 years after the last approval of a marketing 
application in an ICH region (or longer if mandated by the local IRB or regulatory affairs).  
Moreover, they should be retained until there are no pending or contemplated marketing 
applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of 
clinical development of the study drug.  These documents should be retained for a longer period; 
however, if required by the applicable regulatory requirements or by an agreement with the Sponsor.  
It is the responsibility of the Sponsor or designee to inform the Investigator or institution as to 
when these documents no longer need to be retained. 
 
11. Administrative Considerations 
 
The following administrative items are meant to guide the Investigator in the conduct of the trial but 
may be changed based on industry and government standard operating procedures, working practice 
documents, or guidelines.  Any changes in trial procedures will be reported to the IRB but will not 
necessarily result in a protocol amendment. 
 
11.1 
Confidentiality 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a manner 
designed to maintain subject confidentiality.  All records will be kept in a secure storage area with 
limited access.  Clinical information will not be released without the written permission of the 

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subject (or the subject’s guardian), except as necessary for monitoring and auditing by the Sponsor, 
its designee, the FDA or applicable regulatory authorities, or the IRB. 
 
The Investigator and all employees and coworkers involved with this study may not disclose or use 
for any purpose other than performance of the study, any data, record, or other unpublished 
confidential information disclosed to those individuals for the purpose of the study.  Prior written 
agreement from the Sponsor or designee must be obtained for the disclosure of any said confidential 
information to other parties. 
 
11.2 
Institutional Review Board or Independent Ethics 
Committee Approval 
Federal regulations and the ICH guidelines require that approval be obtained from an IRB/Ethics 
Committee (EC) before participation of human subjects in research studies.  Before the study onset, 
the protocol, informed consent, advertisements to be used for subject recruitment, and any other 
written information regarding this study to be provided to the subject or the subject’s legal guardian 
must be approved by the IRB/EC. Documentation of all IRB/EC approvals and of the IRB/EC 
compliance with ICH E6(R2), FDA, TFDA and other applicable regulatory authorities will be 
maintained by the site and will be available for review by the Sponsor or designee. 
 
The Investigator is responsible for obtaining continued review of the clinical research at intervals 
specified by the IRB, but not exceeding 1 year.  The investigator must supply the Sponsor or 
designee with written documentation of continued review of the clinical research. 
 
11.3 
Modification of the Protocol 
This protocol will be implemented as approved by the IRB and no changes will be implemented 
prior to IRB approval except those necessary to remove an apparent immediate hazard to the 
subject.  Amendments to the protocol must be approved by the IRB prior to implementation. 
 
11.4 
Informed Consent 
A signed informed consent form, in compliance with Title 21 of the US CFR Part 50 and according 
to other regulations for non-US sites, will be obtained from each subject before any study-related 
procedures are performed and any personal information is collected. An informed consent template 

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may be provided by the Sponsor or designee to investigative sites.  If any institution-specific 
modifications to study-related procedures, the risk language or any other significant changes that 
would alter the information relayed are proposed or made by the site, the consent must be reviewed 
by the Sponsor or designee before IRB submission.  Once reviewed, the consent will be submitted 
by the Investigator to his or her IRB for review and approval before the start of the study.  If the 
informed consent form is revised during the course of the study, all active participating subjects 
must sign the revised IRB-approved consent form. 
 
Before enrollment, each prospective subject will be given a full explanation of the study and be 
allowed to read the approved informed consent form.  The information given should in a language 
or manner that is easily understandable to participant or legal guardian.  Once the investigator is 
assured that the subject/legal guardian understands the implications of participating in the study and 
have been given the proper time to consider whether to participate or not, the subject/legal guardian 
will be asked to give consent to participate in the study by signing the informed consent form.  The 
Investigator will also sign the form at that time. 
 
The investigator will provide a copy of the signed informed consent form to the subject and/or legal 
guardian.  The original form will be maintained in the subject’s medical records at the site. 
 
11.5 
Protocol Violations and Deviations 
A deviation from the protocol is an unintended and/or unanticipated departure from the procedures 
and/or processes that were approved by the Sponsor and the IRB and were agreed to by the 
investigator.  Deviations usually have an impact on individual subjects or a small group of subjects 
and do not involve inclusion/exclusion or primary endpoint criteria.  A protocol violation occurs (a) 
when there is a non-adherence to the protocol that results in significant additional risk to the 
subject, (b) when the subject or investigator has failed to adhere to significant protocol requirements 
(e.g., inclusion/exclusion criteria, no changes in background ARV), or (c) when there is 
non-adherence to FDA regulations and/or ICH E6(R2) guidelines. 
 
For this protocol, violations will be defined as exceptions to the inclusion or exclusion criteria, 
administering an incorrect dosage, making a change to the subject’s background ARV, failure to 
collect vital signs before and after administering study drug, situations where a subject is required to 
withdraw but the investigator believes the subject should remain in the study, and the use of an 
excluded concomitant medication.  All other departures from the protocol (e.g., missed visit 

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windows, laboratory samples not collected on the required day) will be documented as protocol 
deviations.  The Investigator or designee must document and explain any protocol deviation or 
violation in the subject’s source documentation.  The IRB should be notified of all protocol 
violations and deviations per local institutional policy by the investigator.  Protocol deviations and 
violations will be documented by the responsible clinical site monitor during monitoring visits, and 
those observations will be reviewed with the investigator. 
 
The investigator may implement a change from the protocol without prior Sponsor and IRB 
approval only to eliminate an immediate hazard to a subject.  The implemented change should be 
submitted to the IRB for review as soon as possible. 
 
If the investigator believes that an exception to the protocol is justified for an individual subject, the 
investigator may present the facts and rationale to the medical monitor and request a one-time 
exception.  This request will be submitted in writing via email to the medical monitor for review and 
disposition.  The medical monitor will then email the decision to the investigator regarding approval 
or denial of the request. This written documentation must be filed in the investigator’s study file. 
 
This process will apply if the investigator believes that a subject should receive an excluded 
concomitant medication and remain in the study, or if the investigator believes that a subject should 
remain in the study when the protocol dictates that the subject should be discontinued.  The 
implemented change should be submitted to the IRB for review as soon as possible.  However, it is 
the policy of the Sponsor that there will be no exceptions granted concerning the inclusion and 
exclusion criteria. 
 
11.6 
Study Reporting Requirements 
By participating in this study, the Investigator agrees to submit reports of AEs according to the 
timeline and method outlined in the protocol.  In addition, the Investigator agrees to submit 
periodic reports to his/her IRB as appropriate. 
 
11.7 
Financial Disclosure and Obligations 
Investigators and sub-investigators are required to provide financial disclosure information to allow 
the Sponsor or designee to submit the complete and accurate certification or disclosure statements 
required under Title 21 CFR 54.  In addition, the Investigator and sub-investigators must provide 

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the Sponsor or designee with a commitment to update this information promptly, if any relevant 
changes occur during the course of the investigation and for 1 year following the completion of the 
study. 
 
The Sponsor or designee is not financially responsible for further testing/treatment of any medical 
condition that may be detected during the screening process.  In addition, in the absence of specific 
arrangements, the Sponsor or designee is not financially responsible for treatment of the subject’s 
disease. 
 
11.8 
Investigator Documentation 
Before beginning the study, the Investigator will be asked to comply with ICH E6(R2) 8.2, Title 21 
CFR and other applicable regulatory requirements by providing the essential documents to the 
Sponsor or designee, which include but are not limited to the following: 
 
◼ 
An original investigator-signed investigator agreement page of the protocol; 
◼ 
Documentation of IRB approval of the protocol and informed consent; 
◼ 
The IRB-approved informed consent, samples of site advertisements for recruitment 
for this study, and any other written information regarding this study that is to be 
provided to the subject or legal guardians; 
◼ 
A Form FDA 1572, fully executed, and all updates on a new fully executed Form FDA 
1572; 
◼ 
Curricula vitae for the investigator and each sub-investigator listed on Form FDA 1572.  
A copy of the current license must be provided.  The curricula vitae must be signed and 
dated by the Investigators and sub-investigators within 1 year before study start-up to 
indicate the documents are accurate and current; 
◼ 
Completed financial disclosure forms to allow the Sponsor or designee to submit 
complete and accurate certification or disclosure statements required under Title 21 
CFR 54.  In addition, the investigators must provide to the Sponsor or designee a 
commitment to update this information promptly if any relevant changes occur during 
the course of the investigation and for 1 year following the completion of the study 
(Section 11.7); and 
◼ 
Laboratory certifications and normal ranges for any local laboratories used by the site, in 
accordance with Title 42 CFR 493. 
 

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11.9 
Study Conduct 
The Investigator agrees that the study will be conducted according to the principles of the ICH 
E6(R2), the principles of the World Medical Association Declaration of Helsinki, and regulatory 
requirements of the FDA and TFDA.  The investigator will conduct all aspects of this study in 
accordance with all national, state, and local laws or regulations. 
 
11.10 Publications 
Following completion of the study, the data may be considered for reporting at a scientific meeting 
or for publication in a scientific journal.  In these cases, the Sponsor or designee will be responsible 
for these activities and will work with the investigators to determine how the manuscript is written 
and edited, the number and order of authors, the publication to which it will be submitted, and 
other related issues.  The Sponsor has final approval authority over all such issues. 
 
Data are the property of the Sponsor and cannot be published without prior authorization from the 
Sponsor. 
 
A description of this clinical trial (study) will be available on http://clinicaltrials.gov, as required by 
US Law. 
 
 
 

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