Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Sponsor: University of California, San Diego

 
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Official Title: Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons 
 
NCT02572323 
 
05/19/2020 
 
 

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Version2.1_ATPC_05/19/20 
 
Study Overview 
Title 
Full Study Title 
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons 
PI 
Ron Ellis  
Coordinator 
Anjelica Pascual Cosino 
Project Start 
02/2017 
Project End 
05/2021 
Funding Source/ 
Award Number 
NIH/HIA, Award # R01AG048650 
 
NCT number 
NCT02572323 
Study Design 
Randomized Clinical Trial with randomization to the immediate or deferred 
treatment 
Study Code 
TESB, TESI, TESD 
Consent 
• 
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons 
o 
Consent to Be Screened for a Research Study 
o 
Consent to Act as a Research Subject 
• 
Consent to Act as a Research Subject: Phase II Trial of Tesamorelin for 
Cognition in Aging HIV-Infected Persons: Effects of Tesamorelin on CSF 
Biomarkers Sub-study 
• 
Consent to Act as a Research Subject: Phase II Trial of Tesamorelin for 
Cognition in Aging HIV-Infected Persons: Effects of Tesamorelin on Tau 
Protein Burden using Tau-PET Scan 
Participants 
100 participants seen at UCSD (n=50) and USC (n=50) 
Spanish Speakers 
Yes 
Inclusion/Exclusion Inclusion: HIV+, 40 years and older, NC Impaired 
Exclusion: unwilling to inject TESA, neurocognitive confounding conditions, 
HCV positive with plans to start treatment  
Visits 
TESB: SC1, PE1, 000  
TESI: 002, 004, 012, 024, 048 
TESD: 024, 026, 028, 036, 048 
Visit Interval 
TESB: SC1 and PE1 visits should be within 6 weeks of the 000-visit unless 
repeat W/C measurements are done at the PE1 visit which extends the timeline 
an additional 6 weeks  
TESI: Week 2, 4, 12, 24, 48 
TESD: Week 24, 26, 28, 36, 48 
Assessments 
See Table 1 below. 
Compensation 
Up to $580 in total. 
If x-rays required to determine MRI eligibility: $20 
CSF sub-study: $200-300 depending on number of LPs  
PET sub-study: $100 
Scrip Source 
TESB, TESI, TESD 
Visit Length 
See Table 1 below 
Scheduling 
Dependent on Matthew’s schedule  
Examiners 
NP– SC1: Matthew; 024 and 048: Core testers 
NM, ITW, and Drug Dispensing: Anjelica  
UTOX+ Policy 
Standard procedures – OK for the pt to continue with NP testing if positive for 
meth unless the participant is behaviorally intoxicated. Reschedule if 
behaviorally intoxicated or if positive for other drugs that cannot be explained 
by prescription med; marijuana OK. See coordinator for further questions. 
Co-enrollment 
No co-enrollment in intervention studies  
1. TIMELINE 

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Version2.1_ATPC_05/19/20 
4 years; 12-15 participants per year  
 
Duration of study 
5 years  
Date start enrolling 
02/2017 
Date stop enrolling  
05/2021 
Milestones (# pts/yr, etc) 
2017- 23 participants enrolled  
2018- 18 participants enrolled  
2019- 16 participants enrolled  
2020- TBD 
2021- TBD 
 
 
2. BRIEF STUDY DESCRIPTION  
 
Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat 
accumulation in HIV.  Abdominal fat accumulation is linked to memory and thinking difficulties, and previous 
studies have suggested that tesamorelin also may be beneficial for memory and thinking, but this has not 
been tested in HIV.  
This is a randomized trial in which participants will have a 60% chance of initially receiving tesamorelin (the 
Immediate group) and a 40% chance of initially receiving no treatment (the Deferred group) for 6 months.  
Subsequently, those who initially received no treatment will receive tesamorelin and those who initially 
received tesamorelin will receive no treatment for 6 months. 
This study includes text-messaging, memory and thinking assessments, blood draws and magnetic 
resonance imaging (MRI) scans of the head and abdomen 
 
 
 
 
 
 
3. PARTICIPANTS 
 

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Version2.1_ATPC_05/19/20 
HIV+ adults 40+ years old (N=100): 
- 
UCSD: 50 
- 
USC: 50 
 
Inclusion Criteria: 
1. HIV-1 infection documented by any FDA licensed clinical test including HIV enzyme/antigen test or 
chemiluminescence immunoassay (E/CIA) or plasma HIV-1 RNA viral load. 
2. Antiretroviral therapy: Patient currently receiving a cART regimen ≥12 weeks with no interruptions 
longer than 7 days and HIV <500 copies/ml during that time.   
3. Men or women age 40 and older 
4. Abdominal minimal waist circumference ≥ 95cm for men and ≥94cm for women or minimal waist to 
hip ratio of ≥ 0.88 for women (each based on an average of three separate measurements)   
5. Screening neuropsychological Global Deficit Score of ≥ 0.35 
6. The following laboratory values obtained within 90 days prior to entry by any CLIA certified laboratory. 
• 
Absolute neutrophil count (ANC) ≥750/mm3 
• 
Hemoglobin ≥8.0 g/dL 
• 
Platelet count ≥50,000/mm3 
• 
HgbA1C ≤8.0% and has no plans to start additional antidiabetic medication(s) 
• 
Calculated creatinine clearance of ≥20 mL/min as estimated by the Cockroft-Gault formula  
• 
Aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤5 X 
ULN; alkaline phosphatase <3 x UNL 
• 
Total bilirubin ≤2.5 x ULN (if the participant is receiving atazanavir, a total bilirubin of ≤5 x ULN is 
acceptable).  
7. For females of reproductive potential, negative serum or urine pregnancy test within 30 days prior to 
entry by any test performed by a CLIA certified laboratory or is using a point of care (POC)/ CLIA-
waived test.   
8. Contraception requirements: For females of reproductive potential, she or male partner is willing to 
use a contraceptive during sexual intercourse.  
9. Ability and willingness of participant or legal guardian/representative to provide informed consent 
 
Exclusion Criteria: 
1. Clinical contraindications 
• 
History of neurocognitive confounding conditions that explain current impairment including but not 
limited to stroke, head injury, psychotic disorder, active substance use disorder by DSM, or 
opportunistic CNS infection    
• 
Hepatitis C virus infection defined as HCV antibody positive requiring treatment and plans for 
treatment during study therapy  
• 
Active or relapsing autoimmune disorder that may require immunotherapy during this treatment 
trial 
• 
Active malignancy other than basal or squamous skin cancer.    
2. Breastfeeding or pregnancy 
3. Excluded medications used within the last 90 days: active or planned use of rhGH, anti-TNFa therapy 
or other biologic (tocilizumab, Xelijanz, etc.), systemic corticosteroids, need for prescription dosing of 
NSAIDs administered regularly one or more times daily, or investigational medication    
4. Known allergy/sensitivity or any hypersensitivity to tesamorelin 
5. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere 
with adherence to study requirements  
6. Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to 
entry 
7. Use of tesamorelin in the last 6 months 
 
Exclude possible participants who are co-enrolled in other studies that use overlapping tests, only if those 
studies are expected to re-administer tests in the Tesamorelin battery between the times of the 
Tesamorelin Study baselines and final follow-up evaluations 

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Co-enrollment: 
Participants can be co-enrolled, but can’t have an intervention or NP testing while in this study.  
 
Enrollment Procedure: 
For participants already enrolled at the HNRP, PAR team (Recruitment) will check age of participants and 
that they are not currently participating in other intervention studies at the HNRP. PAR will call 
participants who meet these criteria.  By telephone, they will explain the study and ask screening 
questions (HNRC screening + language of testing form + Tesamorelin Eligibility Checklist – Section 1).  
Information on pre-screening visits of participants who qualify based on their responses will be sent to 
Anjelica for approval. Once approved, participants will be scheduled by PAR (Scheduling). 
 
Recruitment will also be done in the community.  
 
 
4. HNRP CORES 
 
DMIS 
Assistance with creating forms, data storage and management 
Neurobehavioral 
NP testing (including NIH Toolbox Cognition Battery), linking 
PAR 
Recruitment, scheduling, screening, consenting, breathalyzer 
Neuromedical 
Utox, blood draw, neuromed interview, physical exam, iTAB, injection 
training, drug dispensing, linking 
Statistics 
Data analysis  
 
 

 
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5. SCHEDULE OF ASSESSMENTS  
 
Table 1. Assessments by visit, length of visit and total compensation 
Bolded assessments in Period A are completed by the Immediate group only and bolded assessments in Period B are completed by the Deferred 
group only. 
Period A 
Period B 
Visit Description 
Screening 
Pre-
Entry 
Entry 
Week 
2 
Week 4 
Week 
12 
Week 24 
Week 
26 
Week 
28 
Week 
36 
Week 
48 
Length of Visit (hours) 
2 
6* 
5* 
1 
2 
2 
9* 
1 
2 
2 
9* 
Type of Visit  
In-person# 
In-
person# 
In-person# 
Phone 
In-
person# 
In-
person# 
In-person# 
Phone 
In-
person# 
In-
person# 
In-
person# 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
Eligibility Checklist 
X## 
X## 
 
 
 
 
 
 
 
 
 
Drug Dispensing 
 
 
X** 
 
X** 
X## 
X**^ 
 
X** 
X## 
 
Lab Assessments 
Substance Use 
 
 
 
 
 
 
 
 
 
 
 
Urine Drug Screen 
X 
X 
 
 
 
 
X 
 
 
 
X 
Breathalyzer 
X 
X 
 
 
 
 
X 
 
 
 
X 
Pregnancy Test (women) 
X 
X+ 
 
 
 
 
X^ 
 
 
 
 
Fingerstick 
 
 
 
 
 
 
 
 
 
 
 
HIV/HCV Ab rapid test  
X 
 
 
 
 
 
 
 
 
 
 
Blood draw (clinical) 
 
 
 
 
 
 
 
 
 
 
 
CBC 
 
X 
 
 
X 
X$ 
X 
 
X 
X$ 
X 
Chemistry/LFTs 
 
X 
 
 
X 
X$ 
X 
 
X 
X$ 
X 
HgbA1C 
 
X 
 
 
 
 
X 
 
 
 
X 
CD4, HIV RNA 
 
X 
 
 
 
 
X 
 
 
 
X 
Blood draw (research) 
 
 
 
 
 
 
 
 
 
 
 

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IGF-1 levels 
 
X 
 
 
X 
 
X 
 
X 
 
X 
Neuromedical 
 
 
 
 
 
 
 
 
 
 
 
Interview  
Brief## 
Brief## 
Full## 
Brief 
Brief## 
Brief## 
Full## 
Brief 
Brief## 
Brief## 
Full## 
Exam 
WC## 
WC++ 
Full 
Brief 
Brief## 
Full 
Brief## 
Brief## 
Full 
Tes injection training 
 
X*** 
 
 
 
 
X^ 
 
 
 
 
Lumbar Puncture 
 
 
X 
 
 
 
X 
 
 
 
X 
Neuropsychological 
testing 
Brief## 
Full**** 
 
 
 
 
Full 
 
 
 
Full 
iTAB 
 
 
Training## 
X 
X## 
X## 
     
Training^## 
X 
X## 
X## 
X^## 
Imaging 
 
 
 
 
 
 
 
 
 
 
 
MRI Abdominal and Trunk 
Fat 
 
 
X 
 
 
 
X 
 
 
 
 
MRI Brain 
 
 
X 
 
 
 
X 
 
 
 
 
X-rays 
X+++ 
 
 
 
 
 
 
 
 
 
 
PET Scan  
 
 
X 
 
 
 
X^ 
 
 
 
 
Tes: Tesamorelin, iTAB: Individualized Texting for Adherence Building, WC: Waist Circumference 
*Pre-Entry, Entry and Week 24 visit will be split over multiple days; Entry and Week 24 visit will take place at two separate locations 
** If only 4 weeks of study drug is dispensed at Entry or Week 24, then 8 weeks of study drug will be dispensed at the week 4 visit or Week 28 visit. If 
12 weeks of study drug is dispensed at Entry or Week 24, then there will be no dispensing at the week 4 visit. Most participants will receive only 4 
weeks of study drug at the Entry visit. Participants who have a difficult time returning for drug at the Week 4 visit will have 12 weeks of study drug 
dispensed to them at Entry. 
***Tesamorelin injection training will occur after the participant completes all other screening assessments and is deemed eligible  
****Includes Composite International Diagnostic Interview (CIDI) assessment of alcohol, drug use and mental disorders 
^Deferred group only 
+ Repeat pregnancy test at the Pre-Entry visit (COVID19 contingency plan)  
++ Repeat waist circumference measurements at the Pre-Entry visit (COVID19 contingency plan) 
+++Only if needed to determine eligibility for MRI and will take place at a separate location 
# Modified visit (COVID19 contingency plan)  
## Assessment can be done remotely. Once enrolled, the assessment can continue to be done remotely unless the participant reports something that 
the clinician determines needs to be assessed in-person. NM exam will be modified as not all aspects of the SPE1 form can be completed remotely. 
The clinician will coordinate with pharmacy regarding study drug/supply dispensing. (COVID19 contingency plan) 
$ Assessment can be deferred unless the participant reports something that the clinician determines needs to be assessed in-person (COVID19 
contingency plan) 

 
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6. SCHEDULING DETAILS 
NM assessments can be done in any of the clinician rooms. NP assessments can be done in any of the 
NP testing rooms. The clinical coordinator work with PAR to coordinate the timing of 000 and 024 visits 
for participants who are MRI and/or PET scan eligible. PAR will be responsible for scheduling participants 
for their MRI scans at the Keck MRI imaging center. The clinical coordinator and PAR will work together 
to schedule participants for their PET scans at the California Proton Cancer Therapy Center (CPC). CPC 
point of contact is Chris Davis (chris.davis@californiaprotons.com) and Debbie Madueno 
(debbie.madueno@californiaprotons.com). 
 
 
7. COMPENSATION DETAILS 
The total compensation for each visit is in Table 2 below. 
Table 2. Scrip Utility Breakdown 
Study 
Visit 
Compensation Amount 
Assessment 
Visit Total 
Assessment  
TESB 
SC1 
Up to $65 
$15 
Waist measurement and fingerstick 
$15 
Brief medical interview 
$15 
Brief NP assessment and urine specimen 
$20 
X-rays (only if needed to determine MRI eligibility) 
 
PE1 
Up to $100 
$20 
Blood draw 
$15 
Brief medical interview 
$20 
Injection training 
$45 
Full NP assessment and urine specimen 
 
000 
Up to $105 
$20 
NM assessment 
$10 
iTAB training (Immediate group only) 
$75 
Abdominal and brain MRI 
 
TESI 
002 
Up to $15 
$15 
Brief medical assessment 
 
004 
Up to $35 
$20 
Blood draw 
$15 
Brief medical assessment 
 
012 
Up to $35 
$20 
Blood draw 
$15 
Brief medical interview 
 
TESI/
TESD 
024 
Up to $170 
$20 
NM assessment 
$20 
Blood draw 
$10 
iTAB training (Deferred group only) 
$45 
Full NP assessment 
$75 
Abdominal and brain MRI 
 
TESD 
026 
Up to $15 
$15 
Brief medical assessment 
 
028 
Up to $35 
$20 
Blood draw 

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Version2.1_ATPC_05/19/20 
$15 
Brief medical assessment 
 
036 
Up to $35 
$20 
Blood draw 
$15 
Brief medical assessment 
 
TESI/
TESD 
048 
Up to $85 
$20 
NM assessment 
$20 
Blood draw 
$45 
Full NP assessment 
CSF 
sub-
study 
000, 
024, 
048 
Up to $300 
$100 
Lumbar puncture (LP) 
Immediate group receives a LP at 000, 024 and 048 
Deferred group receives a LP at 024 and 048 
PET 
scan 
sub-
study 
000 or 
024 
Up to $100 
$100 
PET scan 
Immediate group receives a PET at 000 
Deferred group receives a PET at 024 
 
• 
Participants will receive $10 compensation for incomplete NM or NP testing (including urine 
sample) 
• 
If a participant begins but does not complete a blood draw or MRI for any reason, the participant 
will receive full compensation for the procedure 
• 
For phone visits (Weeks 2 or 26), the participant will be given the option to have the 
compensation mailed (only applies to scrip payment) or to pick up the payment at their 
convenience. 
• 
If a participant is asked to return for a separate visit if any of the above-described procedures are 
not completed as scheduled, or if any procedures need to be repeated for any reason, the 
participant will be compensated in an amount relative to the amounts listed above for the 
requested procedure. 
 
 
8. ASSESSMENT DETAILS  
 
SC1: 
PAR: Standard HNRP assessments  
COVID19 plan- screening will be done remotely. Consents and W9 form will be signed 
and mailed back to the HNRP in a pre-paid envelope 
Unique assessments and forms include: 
• 
Tesamorelin Eligibility Checklist (TECK)- Used by NM clinician to determine 
TESA eligibility 
• 
Tesamorelin Supplemental Screening Questionnaire (TSSQ)- Used to assess 
participant use of exclusionary medication(s) and/or use of Tesamorelin within 
the past 6-months 
• 
MRI Screening Questionnaire (CH25B)- Used to assess MRI eligibility 
• 
Request for Taxpayer Identification Number and Certification (W9)- UCSD is 
required to report compensation to the IRS when compensation is $600 or more 
in a calendar year 
 
Lab: Standard HNRP assessments 
COVID19 plan- fingerstick rapid screen, pregnancy test (if applicable) and urine drug 
screen will continue to be done in person  
 
NP: Standard HNRP assessments (brief assessment) 
COVID19 plan- testing will be done remotely. Not all of the pre-COVID19 t-scores (Dom, 
Non-Dom, DS, SS, HVLTR-total) will be used to determine NP eligibility to proceed to the 
PE1 visit. The following t-scores will be used to determine NP PE1 eligibility: (f/u with 
Matthew) 

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NM: Standard HNRP assessments can be done remotely 
COVID19 plan- waist circumference measurements will be done remotely using an 
approved tape measurer provided by the HNRP. The participant will measure their 
minimal waist circumference (W/C) three times under the guidance of a clinician. The 
clinician will record the minimal W/C measurements and will defer recording the following 
additional circumference measurements: hip, iliac waist, umbilicus, mid-waist and 
midarm. The interview portion of this visit will be done remotely as well.  
Unique assessments and forms include: 
• 
Clinical Algorithm- Interview Portion (CAIP)- used to assess for neuromedical 
stability. If a comprehensive NP battery was performed within 6-months of SC1 
visit, the comprehensive NP battery can be linked to the PE1 rather than repeat 
testing.  
• 
Tesamorelin Supplemental HIV Questions (TSHQ)- to assess whether patient 
currently receiving a cART regimen ≥12 weeks with no interruptions longer than 
7 days and HIV <500 copies/ml during that time.   
PE1/ITW: 
 
PAR: Standard HNRP assessments 
COVID19 plan- screening can be done remotely. Sub-study consents will be signed and 
mailed back to the HNRP in a pre-paid envelope  
Unique assessments and forms include:  
• 
CSF sub-study consent form- If the participant is found to be eligible, he or she 
will receive 2-3 lumbar punctures (LP) depending which group they are 
randomized to. Those in the immediate group will receive a LP at the 000, 024, 
and 048 visits. Those randomized into the deferred group will receive a LP at the 
024 & 048 visits.  
• 
PET scan sub-study consent form- If the participant is found to be eligible, he or 
she will receive a PET scan prior to starting study drug (Immediate group at the 
000-visit and Deferred group at the 024-visit).  
 
Lab: Standard HNRP assessments  
 
 
COVID19 plan- assessment will continue to remain in-person  
 
NP: Standard HNRP assessments  
COVID19 plan- the participant will complete all assessments that can be done remotely 
in the home setting. Any assessments that cannot be completed remotely will be done in-
person at the HNRP.  
 
NM: Standard HNRP assessments.  
COVID19 plan- the interview portion of this visit will be done remotely. Repeat W/C 
measurements and pregnancy test (if applicable) will be done as a precautionary 
measure to extend the screening timeline. If the participant is eligible to proceed to the 
ITW, deciding to perform the first placebo injection in-person versus remotely will be 
made of a case by case basis (ex: prior experience administering subcutaneous 
injections).  
Unique assessments include: 
• 
Injection Training Week (ITW) where the participant injects the first of five 
placebo injections at the HNRP and completes the remaining four injections at 
home. The Injection Training Week Phone Questionnaire (ITWQ) is completed by 
a clinician once the participant has completed their ITW to assess whether he or 
she is interested in continuing on with the study.  
 
000: 
 
PAR: Standard HNRP assessments 
COVID19 plan- screening will be done remotely. Consents will be signed and mailed 
back to the HNRP in a pre-paid envelope 
 
Lab: Standard HRNP assessments 
COVID19 plan- lab involvement will only occur if the participant is randomized into the 
Immediate group and is enrolled in the CSF sub-study 
 
NP: Not applicable  

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NM: Standard HNRP assessments.  
COVID19 plan- the interview portion for this visit will be done remotely. The exam and 
lumbar puncture (if applicable) will continue to take place in-person. If randomized into 
the Immediate group, the participant will administer their first injection in the presence of 
the clinician.  
Unique assessments include: 
• 
Supplemental Exam (SPE1)- assesses for signs and symptoms that occur more 
frequently when taking Tesamorelin. 
• 
ITAB forms (PTMO, ITAB, WRTS)- used by the interviewer to set up the text 
message component of TESA 
• 
Motivational Interview Responses (MIRS)- to be used by NM staff if a participant 
fails to respond to their TESA texts three consecutive times. NM staff will use 
MIRS to encourage medication adherence  
• 
Study Drug Count (CA35)- used by the interviewer to monitor medication 
adherence. 
CSF: Lumbar Puncture Procedure Note (CA21)- only used if the participant is enrolled in the CSF 
sub-study (Immediate group only) 
 
PET: For those enrolled in the PET scan sub-study, participants in the Immediate group will 
receive their pre-TESA scan.   
 
002/026: Telephone interview  
 
PAR: Not applicable  
 
Lab: Not applicable  
 
NP: Not applicable  
 
NM: Standard HNRP assessments.  
 
 
COVID19 plan- the interview portion of this exam will continue to be done via telephone 
Unique assessments include: 
• 
Daily Injection and Texting Evaluation (DITE)- assesses how the participant is 
doing with their daily injection and whether or not they are having any issues with 
their text message reminders to take TESA. 
• 
Adverse Events (CDT7)- records any adverse signs and symptoms that are new 
or have worsened since starting TESA. 
 
004/028: 
 
PAR: Standard HRNP assessments  
COVID19 plan- screening will be done remotely. Consents will be signed and mailed 
back to the HNRP in a pre-paid envelope 
 
Lab: Standard HNRP assessments  
 
 
COVID19 plan- blood draw will continue to be done in-person 
 
NP: Not applicable  
 
NM: Standard HRNP assessments 
COVID19 plan- the interview portion for this visit will be done remotely. The exam will 
continue to be done in-person to ensure that adverse events (AEs) are discovered in a 
timely manner. Study drug/supplies will be dispensed in-person.  
Unique assessments include: 
• 
Daily Injection and Texting Evaluation (DITE) 
• 
Adverse Events (CT7) 
• 
Supplemental Exam (SPE1) 
 
012/036:  
 
PAR: Standard HNRP assessments  
COVID19 plan- screening will be done remotely. Consents will be signed and mailed 
back to the HNRP in a pre-paid envelope 
 
Lab: Standard HRNP assessments  

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Version2.1_ATPC_05/19/20 
COVID19 plan- bloodwork will be deferred so long as the prior labs (004/028) are stable 
and the participant does not report something that the clinician determines needs to be 
assessed in-person 
 
NP: Not applicable  
 
NM: Standard HRNP assessments.  
COVID19 plan- the interview portion for this visit will be done remotely. The exam will be 
modified as not all aspects of the exam can be completed remotely. The clinician will 
coordinate with pharmacy regarding study drug/supplies dispensing.  
Unique assessments include: 
• 
Daily Injection and Texting Evaluation (DITE) 
• 
Adverse Events (CT7) 
• 
Supplemental Exam (SPE1) 
 
024: 
 
PAR: Standard HRNP assessments  
COVID19 plan- screening will be done remotely. Consents will be signed and mailed 
back to the HNRP in a pre-paid envelope 
 
Lab: Standard HRNP assessments 
 
 
COVID19 plan- blood draw will continue to be done in person  
• 
Females in the Deferred group will have another Rapid Screen Pregnancy Test 
run prior to starting drug 
 
NP: Standard HNRP assessments  
COVID19 plan- the participant will complete all assessments that can be done remotely 
in the home setting. Any assessments that cannot be completed remotely will be done in-
person at the HNRP.  
 
NM: Standard HNRP assessments 
COVID19 plan- the interview portion for this visit will be done remotely. The exam and 
lumbar puncture (if applicable) will continue to take place in-person. If randomized into 
the Deferred group, the participant will administer their first injection in the presence of 
the clinician. 
Unique assessments include:  
• 
Supplemental Exam (SPE1) 
• 
ITAB forms (PTMO, ITAB, WRTS), Motivational Interview Responses (MIRS)- 
Deferred group only 
• 
iTAB-T Feedback Questionnaire (BD31)- assess participant perception of texting 
component of TESA (Immediate group only) 
• 
Study Drug Count (CA35) 
CSF: Lumbar Puncture Procedure Note (CA21)- enrolled participants in both the Immediate and 
Deferred groups.  
PET: For those enrolled in the PET scan sub-study, participants in the Deferred group will receive 
their pre-TESA PET scan.   
 
048: 
 
PAR: Standard HNRP assessments  
COVID19 plan- screening will be done remotely. Consents will be signed and mailed 
back to the HNRP in a pre-paid envelope 
 
Lab: Standard HNRP assessments  
COVID19 plan- blood draw will continue to be done in person 
 
NP: Standard HRNP assessments  
COVID19 plan- the participant will complete all assessments that can be done remotely 
in the home setting. Any assessments that cannot be completed remotely will be done in-
person at the HNRP.  
 
NM: Standard HNRP assessments 
COVID19 plan- the interview portion for this visit will be done remotely. The exam and 
lumbar puncture (if applicable) will continue to take place in-person.  

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Version2.1_ATPC_05/19/20 
Unique assessments include:  
• 
Supplemental Exam (SPE1) 
• 
iTAB-T Feedback Questionnaire (BD31)- Deferred group only 
• 
Study Drug Count (CA35)- Deferred group only 
CSF: Lumbar Puncture Procedure Note (CA21)- enrolled participants in both the Immediate and 
Deferred groups.  
PET: For pts in the PET sub-study, Deferred participants will receive their post-TESA PET scan.  
 
 
Lab Protocol: Please review the NM Lab Ops protocol for further information  
 
Table 3. Laboratory specimen collection  
 
Fluid 
Type 
Visits 
Specimen 
Tube Type 
Specimen 
Volume 
Specimen 
Processing 
Complete Blood 
Count (CBC) 
Plasma 
PE1, 004, 012, 
024, 028, 036, 048 
Lavender 
Top 
4ml 
UCSD & 
LabCorp 
T-cell subset 
Plasma 
PE1, 024, 048 
Yellow Top 
6ml 
UCSD & 
LabCorp 
HIV RNA 
Plasma 
 
Lavender 
Top 
2ml 
UCSD & 
ARUP 
Comprehensive 
Metabolic Panel 
(CMP) and LFTs 
Plasma 
PE1, 004. 012, 
024, 028, 036, 048 
Tiger Top 
8.5ml 
UCSD & 
LabCorp 
HgbA1C 
Plasma 
PE1, 024, 048 
Lavender 
Top 
4ml 
UCSD & 
LabCorp 
IGF-1 
Plasma 
PE1, 004, 024, 
028, 048 
Lavender 
Top 
12ml 
UCSD & USC 
HIV RNA 
CSF 
000 (if in the 
Immediate arm), 
024, 048 
Polystyrene 
collection 
tube 
12ml 
UCSD & 
ARUP 
Storage 
Blood & 
CSF 
PE1, 004, 012, 
024, 028, 036, 048 
Lavender 
Top and 
Polystyrene 
collection 
tube 
Varies based on 
available 
collection at the 
time of the visit 
UCSD and 
then sent to 
the Freezer 
Farm 
 
 
9. NEW DEVICES OR TECHNOLOGY   
No new devices or technology are being used in this clinical trial.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 13 of 19 
 
Version2.1_ATPC_05/19/20 
 
10. FORMS  
 
TESA (or TESB at UCSD) includes screening (SC1), Pre-Entry (PE1) and Entry (000) visits  
* Use only if randomized into the Immediate group 
** Use only if randomized into the Immediate group and enrolled into the CSF sub-study 
# Use if conducting a remote SC1 visit  
$ Use if conducting a combined SC1/PE1 visit  
 
 
Table 4. Case Report Forms by Visit  
CRF Name  
CRF ID 
SC1 
PE1 
000 
  
Screening 
Pre-
Entry 
Entry 
In-person 
 
X 
X 
X 
Screening Battery Forms  
 
 
 
Detailed MRI Screening Questionnaire 
CH25B 
X 
 
 
DAST- Modified Version 
TM12 
X 
 
 
Audit 
NP49 
X 
 
 
Request for Taxpayer Identification Number and 
Certification 
W9 
X 
 
 
Bill of Rights 
SD25 
X 
 
 
Screening & Enrollment Questionnaire 
SE01 
X 
 
 
Demographics & Locator Questionnaire 
DL01E 
X 
 
 
Core Screening Questionnaire: Studies & 
Procedures 
PS01 
X 
 
 
Core Screening Questionnaire: Employment, 
Education, and Living Situation 
PS02 
X 
 
 
1993- Modified CDC Classification Worksheet 
CH43 
X 
 
 
Core Screening Questionnaire: Overall Health 
PS03 
X 
 
 
Core Screening Questionnaire: Substance Use 
PS04 
X 
 
 
Core Screening Questionnaire: Driving 
PS06 
X 
 
 
HNRP Screening Questionnaire: HIV 
PS08 
X 
 
 
 
Core Screening Questionnaire: Intervention 
Studies 
PS05 
X 
 
 
 
Core Screening Questionnaire: Testing 
Language 
PS07 
X 
 
 
Wrat 4 Reading (Green)- Examiner use only 
TB25B 
X 
 
 
Assessment of Informed Consent- Participant 
Version 
SD17_TESA 
X 
 
 
 
Assessment of Informed Consent- Evaluator 
Version 
SD18 
X 
 
 
Tesamorelin Eligibility Checklist 
TECK 
X 
 
 
 
Tesamorelin Supplemental Screening 
Questionnaire 
TSSQ 
X 
 
 
Tesamorelin MRI Preparation Guidelines 
MRIP 
X 
 
 

Page 14 of 19 
 
Version2.1_ATPC_05/19/20 
Neuromedical Battery Forms  
 
 
 
 
Neuromed. Medications Adherence (Handout) 
CA15 
X 
 
X 
Brief Medical History Questionnaire-Baseline 
(Handout) 
TB13A 
X 
 
 
Lipoatrophy Questionnaire (Handout) 
CH17 
 
 
X 
Diagnosis ICD-9 
CA16 
X 
X 
X 
Cardiovascular and Stroke Risk Questionnaire 
CH53 
 
 
X 
Medication Summary 
CA33 
X 
X 
X 
1993 Modified CDC Classification Worksheet 
CH43 
X 
X 
X 
Antiretroviral Summary 
CH36 
X 
 
X 
Current Antiretroviral Drugs 
CH33 
 
X 
X 
ACTG Adherence to Anti-HIV Medications 
CA13 
 
 
X 
Neurological History and Examination 
CH40 
 
 
X 
Supplemental Physical Exam 
SPE1 
 
 
X 
Vital Signs 
CA7 
 
X 
X 
ARV Utility Placeholder 
ARV 
X 
X 
X 
Tesamorelin Supplemental HIV Questions 
TSHQ 
X 
 
 
Anthropomorphic Measurement 
T19 
X 
 
 
Clinical Algorithm- Interview Portion 
CAIP 
X 
 
 
Study Drug Count 
CA35 
 
 
X* 
 
 
 
 
 
iTAB forms 
 
 
 
iTAB-T Phone and Text Message Options 
PTMO 
 
 
X* 
TESA iTAB Instructions Text Setup 
ITAB 
 
 
X* 
iTAB-T Wrong Response Tracking Sheet 
WRTS 
 
 
X* 
Motivational Interview Responses 
MIRS 
 
 
X* 
Injection Training Week Battery Forms  
  
 
 
 
Injection Training Week Phone Questionnaire 
ITWQ 
 
X 
 
Blood and CSF Battery Forms 
 
 
 
 
Specimen Orders 
CA20 
 
X 
X 
Rapid Screen Results 
CA32 
X 
 
 
Lumber Puncture Procedure Note 
CA 21 
 
 
X** 
Utox Battery Forms  
  
 
 
 
Toxicology Test and Breathalyzer Results 
CA17 
X 
X 
 
Neurobehavioral Battery Forms 
 
 
 
 
Neurobehavioral History- Interval 
NPNI 
X#$ 
X 
 
Behavioral Notes 
NP31 
X#$ 
X 
 
Hopkins Verbal Learning Test Revised- Record 
Form E 
TB15E 
X$ 
X 
 
Hopkins Verbal Learning Test-Revised 
TB15A-F 
X# 
 
 
WAIS-III Digit Symbol 
ND16 
X$ 
 
 
WAIS-III Symbol Search 
ND18 
X#$ 
 
 
Grooved Pegboard Test Summary Sheet 
TB31 
X$ 
 
 
PASAT 50 
NP17B 
X# 
 
 
Stroop Test 
NC6N 
X# 
 
 
Becks Depression Inventory-II 
CH3 
 
X 
 

Page 15 of 19 
 
Version2.1_ATPC_05/19/20 
 
 
TESI includes visits for the Immediate arm: Week 2 (002), Week 4 (004), Week 12 (012), Week 24 (024) 
and Week 48 (048)  
Patient’s Assessment of Own Functioning 
NP6 
 
X 
 
POMS 65 Questionnaire 
NP30 
 
X 
 
Activities of Daily Living 
NC2 
 
X 
 
MOS- HIV Health Survey 
CH14 
 
X 
 
Temporal Experience of Pleasure Scale 
TEPS 
 
X 
 
Frontal Systems Behavioral Scale 
ND35 
 
X 
 
Hiscock Digit Memory Test 
NC3 
 
X 
 
Brief Visuospatial Memory Test- Revised 
TB16 
 
X 
 
Trail Making Test- Part A 
NP19A 
 
X 
 
Trail Making Test- Part B 
NP19B 
 
X 
 
WAIS-III Letter-Number Sequencing 
ND19 
 
X 
 
Wisconsin Card Sorting Test 
WISCONSIN 
 
X 
 
Controlled Oral Word Associated Test- FAS 
NP23A 
 
X 
 
Category Fluency Test 
NP27 
 
X 
 
Stroop Test 
NC6N 
 
X 
 
Paced Auditory Serial Addition Tast-1 Channel 
NP17B 
 
X 
 
Wrat 4 Reading- Examiner use only 
TB25A 
 
X 
 
UCSD Performance-based Skills Assessment 
Brief (UPSA-B) Scoring Form 
NP57 
 
X 
 
NIH Toolbox Administration 
TM82 
 
X 
 
DSMIV Diagnostic Scores 
CIDI 
 
X 
 
Substance Use 
CH13A 
 
X 
 
NIDA Substance Use History 
ND25 
 
X 
 
Composite International Diagnostic Interview 
(CIDI) Modules 
NP54 
 
X 
 
CRF Name  
CRF ID 
002 
004 
012 
024 
048 
  
Week 
2 
Week 
4 
Week 
12 
Week 
24 
Week 
48 
In-person 
X 
X 
X 
X 
Neuromedical Battery Forms 
Neuromed. Medications Adherence 
(Handout) 
CA15 
X 
X 
Brief Medical History Questionnaire-
Baseline (Handout) 
TB13A 
X 
Diagnosis ICD-9 
CA16 
X 
X 
X 
X 
X 
Adverse Events 
CT7 
X 
X 
X 
X 
X 
Cardiovascular and Stroke Risk 
Questionnaire 
CH53 
X 
X 
Medication Summary 
CA33 
X 
X 
X 
X 
X 
Study Drug Count 
CA35 
X 
X 
X 
1993 Modified CDC Classification 
Worksheet 
CH43 
X 
X 
X 
X 
X 
Antiretroviral Summary 
CH36 
X 
X 
X 
X 
X 

Page 16 of 19 
 
Version2.1_ATPC_05/19/20 
Current Antiretroviral Drugs 
CH33 
X 
X 
X 
X 
ACTG Adherence to Anti-HIV 
medications 
CA13 
X 
X 
Neurological History and Examination 
CH40 
X 
X 
Supplemental Physical Exam 
SPE1 
X 
X 
X 
X 
Anthropomorphic Measurement 
T19 
X 
X 
Vital Signs 
CA7 
X 
X 
X 
X 
Daily Injection and Texting Evaluation 
DITE 
X 
X 
X 
 
 
ARV Utility Placeholder 
ARV 
X 
X 
X 
X 
X 
iTAB forms 
iTAB Feedback Questionnaire 
BD31 
X 
Blood and CSF Battery Forms 
Specimen Orders 
CA20 
 
X 
X 
X 
X 
Lumbar Puncture Procedure Note 
CA21 
 
 
 
X 
X 
Utox Battery Forms 
 
 
 
 
 
 
Toxicology Test and Breathalyzer 
Results 
CA17 
 
 
 
X 
X 
Neurobehavioral Battery Forms 
 
 
 
 
 
 
Neurobehavioral History- Interval 
NPNI 
 
 
 
X 
X 
Behavioral Notes 
NP31 
 
 
 
X 
X 
Hopkins Verbal Learning Test Revised- 
Record Form E 
TB15E 
 
 
 
X 
X 
WAIS-III Digit Symbol 
ND16 
 
 
 
X 
X 
WAIS-III Symbol Search 
ND18 
 
 
 
X 
X 
Grooved Pegboard Test Summary Sheet 
TB31 
 
 
 
X 
X 
Becks Depression Inventory-II 
CH3 
 
 
 
X 
X 
Patient’s Assessment of Own 
Functioning 
NP6 
 
 
 
X 
X 
POMS 65 Questionnaire 
NP30 
 
 
 
X 
X 
Activities of Daily Living 
NC2 
 
 
 
X 
X 
MOS- HIV Health Survey 
CH14 
 
 
 
X 
X 
Temporal Experience of Pleasure Scale 
TEPS 
 
 
 
X 
X 
Frontal Systems Behavioral Scale 
ND35 
 
 
 
X 
X 
Hiscock Digit Memory Test 
NC3 
 
 
 
X 
X 
Brief Visuospatial Memory Test- Revised 
TB16 
 
 
 
X 
X 
Trail Making Test- Part A 
NP19A 
 
 
 
X 
X 
Trail Making Test- Part B 
NP19B 
 
 
 
X 
X 
WAIS-III Letter-Number Sequencing 
ND19 
 
 
 
X 
X 
Wisconsin Card Sorting Test 
WISCO
NSIN 
 
 
 
X 
X 
Controlled Oral Word Associated Test- 
FAS 
NP23A 
 
 
 
X 
X 
Category Fluency Test 
NP27 
 
 
 
X 
X 
Stroop Test 
NC6N 
 
 
 
X 
X 

Page 17 of 19 
 
Version2.1_ATPC_05/19/20 
 
 
 
 
 
 
 
 
 
 
 
 
TESD includes visits for the Deferred arm: Week 24 (024), Week 26 (026), Week 28 (028), Week 36 
(036) and Week 48 (048)  
CRF Name 
CRF ID 
024 
026 
028 
036 
048 
  
Week 
24 
Week 
26 
Week 
28 
Week 
36 
Week 
48 
In-person 
X 
X 
X 
X 
Neuromedical Battery Forms 
Neuromed. Medications Adherence 
(Handout) 
CA15 
X 
X 
Brief Medical History Questionnaire-
Baseline (Handout) 
TB13A 
X 
X 
Diagnosis ICD-9 
CA16 
X 
X 
X 
X 
X 
Adverse Events 
CT7 
 
X 
X 
X 
X 
Cardiovascular and Stroke Risk 
Questionnaire 
CH53 
X 
X 
Medication Summary 
CA33 
X 
X 
X 
X 
X 
Study Drug Count 
CA35 
X 
X 
X 
X 
1993 Modified CDC Classification 
Worksheet 
CH43 
X 
X 
X 
X 
X 
Antiretroviral Summary 
CH36 
X 
X 
X 
X 
X 
Current Antiretroviral Drugs 
CH33 
X 
X 
X 
X 
ACTG Adherence to Anti-HIV 
medications 
CA13 
X 
X 
Neurological History and Examination 
CH40 
X 
X 
Supplemental Physical Exam 
SPE1 
X 
X 
X 
X 
Anthropomorphic Measurement 
T19 
X 
X 
Vital Signs 
CA7 
X 
X 
X 
X 
ARV Utility Placeholder 
ARV 
X 
X 
X 
X 
X 
Daily Injection and Texting Evaluation 
DITE 
 
X 
X 
X 
 
 
 
 
 
 
 
 
iTAB forms 
iTAB-T Phone and Text Message 
Options 
PTMO 
X 
iTAB Instructions Text Setup 
ITAB 
X 
 
 
 
 
iTAB-T Wrong Response Tracking Sheet 
WRTS 
X 
iTAB-T Feedback Questionnaire 
BD31 
X 
Paced Auditory Serial Addition Test-1 
Channel 
NP17B 
 
 
 
X 
X 
Wrat 4 Reading- Examiner use only 
TB25A 
 
 
 
X 
X 
UCSD Performance-based Skills 
Assessment Brief (UPSA-B) Scoring 
Form 
NP57 
 
 
 
X 
X 
NIH Toolbox Administration 
TM82 
 
 
 
X 
X 
DSMIV Diagnostic Scores 
CIDI 
 
 
 
X 
X 

Page 18 of 19 
 
Version2.1_ATPC_05/19/20 
Motivational Interview Responses 
MIRS 
X 
Blood and CSF Battery Forms 
Rapid Screen Results 
CA32 
X 
Specimen Orders 
CA20 
X 
 
X 
X 
X 
Lumbar Puncture Procedure Note 
CA21 
X 
 
 
 
X 
Utox Battery Forms 
Toxicology Test and Breathalyzer 
Results 
CA17 
X 
 
 
 
X 
Neurobehavioral Battery Forms 
 
 
 
 
 
 
Neurobehavioral History- Interval 
NPNI 
X 
 
 
 
X 
Behavioral Notes 
NP31 
X 
 
 
 
X 
Hopkins Verbal Learning Test Revised- 
Record Form E 
TB15E 
X 
 
 
 
X 
WAIS-III Digit Symbol 
ND16 
X 
 
 
 
X 
WAIS-III Symbol Search 
ND18 
X 
 
 
 
X 
Grooved Pegboard Test Summary Sheet 
TB31 
X 
 
 
 
X 
Becks Depression Inventory-II 
CH3 
X 
 
 
 
X 
Patient’s Assessment of Own 
Functioning 
NP6 
X 
 
 
 
X 
POMS 65 Questionnaire 
NP30 
X 
 
 
 
X 
Activities of Daily Living 
NC2 
X 
 
 
 
X 
MOS- HIV Health Survey 
CH14 
X 
 
 
 
X 
Temporal Experience of Pleasure Scale 
TEPS 
X 
 
 
 
X 
Frontal Systems Behavioral Scale 
ND35 
X 
 
 
 
X 
Hiscock Digit Memory Test 
NC3 
X 
 
 
 
X 
Brief Visuospatial Memory Test- Revised 
TB16 
X 
 
 
 
X 
Trail Making Test- Part A 
NP19A 
X 
 
 
 
X 
Trail Making Test- Part B 
NP19B 
X 
 
 
 
X 
WAIS-III Letter-Number Sequencing 
ND19 
X 
 
 
 
X 
Wisconsin Card Sorting Test 
WISCO
NSIN 
X 
 
 
 
X 
Controlled Oral Word Associated Test- 
FAS 
NP23A 
X 
 
 
 
X 
Category Fluency Test 
NP27 
X 
 
 
 
X 
Stroop Test 
NC6N 
X 
 
 
 
X 
Paced Auditory Serial Addition Test-1 
Channel 
NP17B 
X 
 
 
 
X 
Wrat 4 Reading- Examiner use only 
TB25A 
X 
 
 
 
X 
UCSD Performance-based Skills 
Assessment Brief (UPSA-B) Scoring 
Form 
NP57 
X 
 
 
 
X 
NIH Toolbox Administration 
TM82 
X 
 
 
 
X 
DSMIV Diagnostic Scores 
CIDI 
X 
 
 
 
X