Conditions: HIV Infections Renal Transplant Rejection
Keywords: HIV Positive Post Renal Transplant Bictegravir/Emtricitabine/Tenofovir Alafenamide Antiretroviral Biktarvy
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
This is an open-label study, where participants will be switched from their current HIV medication to the study drug, BIC/F/TAF. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of BIC/F/TAF. The investigator hypothesizes that BIC/F/TAF will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.

Detailed description:

Arms:
arm 1: Participants receive a BIC/F/TAF tablet orally once daily with or without food.

Interventions: intervention 1: BIC/F/TAF 50Mg-200Mg-25Mg Tablet
Intervention descriptions: intervention 1: A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.

Protocol document:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
 
Page 1 of 1 
 
Protocol Cover Sheet 
 
 
 
 
Protocol Title:  
The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/ 
Emtricitabine (FTC)/ Tenofovir Alafenamide (TAF) Regimen in Virally 
Suppressed HIV-Positive Patients Post-Renal Transplant 
 
Principal Investigator:  
Catherine Small, MD 
 
NCT number:   
 
NCT04530630 
 
Document Date:  
 
March 15, 2023 
 


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TITLE: The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/ Emtricitabine(FTC)/ 
Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed HIV-Positive Patients Post-Renal Transplant 
 
 
Version Date: 03/15/2023, Version 5.0 
 
Funding Source(s): Gilead Sciences, Inc. 
 
Principal Investigator: 
 
Name   
Catherine B. Small, MD 
Address  
1300 York Avenue 
 
 
 
Mailbox 125 
 
 
 
New York, NY 10065 
Telephone  914-552-5960 
Fax  
212-746-6320 
E-mail   
cbs9003@med.cornell.edu 
 
Participating Sites: None 
 
 


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Statement of Compliance 
 
 
(1) The trial will be conducted in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without 
prior agreement from the Investigational New Drug (IND) or Investigational Device Exemption 
(IDE) sponsor, funding agency and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All 
personnel involved in the conduct of this study have completed Human Subjects Protection and 
ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled. Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study. All 
changes to the consent form will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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1. Protocol Summary 
 
Full Title: 
 
 
 
 
The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/  
 
 
 
 
 
 
Emtricitabine (FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally   
 
 
 
 
 
 
Suppressed HIV-Positive Patients Post-Renal Transplant 
Short Title:  
 
 
 
Switch to BIC/FTC/TAF after Renal Transplant 
Clinical Phase:  
 
 
IV 
Principal Investigator:  
 
Catherine B. Small, MD 
Study Description:  
 
Hypothesis: We hypothesize that BIC/F/TAF will be efficacious and safe 
in the management of HIV+ post renal transplant patients, and will have 
few adverse reactions and drug-drug interactions with tacrolimus in this 
population 
Sample Size: 
 
N = 20 
Study Population: 
 
Virally-suppressed HIV+ adults post-renal transplant 
Enrollment Period: 
 
November 2020 to May 2023 
Study Design: 
Single arm, open-label, switch study, following subjects for 48 weeks 
with a 6 month follow-up 
Study Duration: 
 
November 2020 – December 2024 
Participant Duration: 
 
In this single arm, open-label, switch study, we propose to switch virally 
suppressed HIV+ adults post-renal transplant to BIC/F/TAF and follow 
the subjects for 48 weeks with a 6 month follow-up (Section 6.1). 
Study Agent: 
 
BIC/F/TAF® (BIC/F/TAF) 
Primary Objectives: 
 
1. To determine the efficacy of BIC/F/TAF in HIV+ patients post renal 
transplant at 24 weeks and 48 weeks post-switch to BIC/F/TAF. 
 
 
2. To assess the safety and tolerability of BIC/F/TAF in HIV+ patients 
post renal transplant at 24 weeks and 48 weeks post-switch to 
BIC/F/TAF. 
 
 
3. To assess the pharmacokinetics of BIC/F/TAF in HIV+ patients post 
renal transplant and its interactions with immunosuppressive agents 
(Tacrolimus) at 12 weeks post-switch to BIC/F/TAF. 
 
 
4. To assess renal biomarkers including urine protein/creatinine ratio; 
urine albumin/creatinine ratio; eGFR; serum BUN, creatinine and 
phosphorus; tacrolimus levels; retinol 2 binding protein and B2 
microglobulin post renal transplant at 24 weeks and 48 weeks post-
switch to BIC/F/TAF. 
Secondary Objectives:  
1. To assess the incidence of kidney graft rejection after switching to 
BIC/F/TAF post renal transplant at 24 weeks and 48 weeks post-switch 
to BIC/F/TAF. 
 
 
2. To assess the immunologic activity (CD4 count/percentage) of 
BIC/F/TAF post renal transplant in conjunction with immunosuppressive 
agents (tacrolimus) at 24 weeks and 48 weeks post-switch to BIC/F/TAF. 
 
 
3. To determine patient satisfaction with BIC/F/TAF post renal 
transplant by utilizing a questionnaire to assess health-related quality of 
life outcomes at 24 weeks and 48 weeks post-switch to BIC/F/TAF. 


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Primary Endpoints: 
 
1. Proportion of subjects with plasma HIV-1 RNA <50 copies/ml at week 
48. 
 
 
2. Safety and tolerability (monitoring and recording adverse events) in 
subjects who switched from a prior ARV regimen to BIC/F/TAF. 
 
 
3. Pharmacokinetics of BIC/F/TAF and tacrolimus, including intracellular 
TAF levels (dried blood spot, PBMC). 
Secondary Endpoints:  
1. Changes from baseline in CD4+ T lymphocyte cell count/percentages 
post renal transplant. 
 
 
2. Incidence of rejection rates of the kidney transplant post renal 
transplant and correlation with tacrolimus levels. 
 
 
3. Patient satisfaction with reduced pill burden and adverse events with 
BIC/F/TAF. 
 
 


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1.2 Study Objectives 
 
 
The specific aims of this study are as follows: 
1. To determine the efficacy, safety, and tolerability of Bictegravir/Emtricitabine/Tenofovir 
Alafenamide (BIC/F/TAF) in HIV+ patients post renal transplant. 
2. To assess the pharmacokinetics and drug/drug interactions with immunosuppressive agents 
(tacrolimus) of BIC/F/TAF in HIV+ patients post renal transplant and preservation of renal 
function. 
 
1.2.1  Primary Objectives  
 
The primary objectives of this study are as follows: 
1. To determine the efficacy of BIC/F/TAF in HIV+ patients post renal transplant. 
2. To assess the safety and tolerability of BIC/F/TAF in HIV+ patients post renal transplant. 
3. To assess the pharmacokinetics of BIC/F/TAF in HIV+ patients post renal transplant and its 
interactions with immunosuppressive agents (Tacrolimus). 
4. To assess renal biomarkers including urine protein/creatinine ratio; urine albumin/creatinine 
ratio; eGFR; serum BUN, creatinine and phosphorus; tacrolimus levels; retinol 2 binding protein 
and B2 microglobulin post renal transplant. 
 
1.2.2  Secondary Objectives  
 
1.  To assess the incidence of kidney graft rejection after switching to BIC/F/TAF post renal 
transplant. 
2. To assess the immunologic activity (CD4 count/percentage) of BIC/F/TAF post renal transplant in 
conjunction with immunosuppressive agents (tacrolimus). 
3. To determine patient satisfaction with BIC/F/TAF post renal transplant by utilizing a 
questionnaire to assess health-related quality of life outcomes. 
 
 
2. Background 
 
At NewYork-Presbyterian Hospital-Weill Cornell Medicine, we have a robust Renal Transplant 
Program, including renal transplantation in HIV+ patients. The Renal Transplant Program works in 
close collaboration with the Transplant/Oncology Infectious Diseases Program, including clinical 
research trials. There have been 42 renal transplants performed in HIV+ patients at our institution in 
the past 10 years, including two HIV to HIV renal transplants. Thirty-seven patients (excluding HIV to 
HIV renal transplants) remain alive and are eligible for study consideration. Only four are receiving 
TAF-containing regimens; the remaining 33 are on various antiretroviral (ARV) regimens including 
protease inhibitors, cobicistat and ritonavir (started by and maintained by their community HIV 
primary care physicians), which increase drug-drug interactions with tacrolimus and jeopardize the 
kidney transplant, as well as increasing pill burden. Therefore, a new single tablet ARV with less 


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drug-drug interactions is important to this unique population. Data from 4 clinical trials (1-5) show 
that the single tablet regimen containing BIC/F/TAF (Bictegravir/Emtricitabine/Tenofovir 
Alafenamide) is safe and efficacious and non-inferior to other standard ARV regimens. No patients 
had to discontinue the drug due to renal events and no patients developed treatment-emergent 
resistance. BIC had no impact on severe renal impairment (eGFRCG 15-29 mL/min), no effect on 
actual GFR (iohexol clearance) and minimal effect on estimated GFR. There were no 
discontinuations due to adverse renal events and no proximal renal tubulopathy. TAF is a novel 
tenofovir prodrug (6,7) with improved renal and bone safety compared to Tenofovir. As reported in 
JAIDS 2016 (5), switching HIV-positive patients with mild to moderate renal impairment from a prior 
TDF-based regimen to Elvitegravir/Cobicistat/Emtricitabine/TAF (E/C/F/TAF) resulted in significant 
decreases in proteinuria, albuminuria and tubular proteinuria without dose adjustment. 
 
Kidney transplantation is successful in HIV+ patients although rejection rates are higher than in 
non-HIV+ transplant patients (8). The greatest clinical challenge is to achieve therapeutic and 
nontoxic levels of the immunosuppressive drugs, especially Tacrolimus, in this population, due to 
the complicated pharmacokinetic interactions of these agents with antiretroviral agents (ARV), 
especially protease inhibitors, cobicistat, and ritonavir (8). Non-therapeutic exposure to tacrolimus 
contributes to higher rate of rejection, so it is important to study ARV agents with less drug-drug 
interactions that are safe in this special population. We are currently completing a manuscript 
addressing this issue at our institution and the kidney transplant team has presented preliminary 
data in a poster at the American Transplant Congress in 2018 (Al Jurdi, Clinical Outcomes of HIV-
Infected Kidney Transplant Recipients With An Early Corticosteroid Withdrawal Protocol). It is 
important to closely follow the CD4 lymphocyte counts and percentages in this unique population 
and the effect on HIV infection and immunosuppression. Preferred ARV regimens in HIV+ patients 
post renal transplant include integrase inhibitors and TAF, with the goal to avoid protease inhibitors, 
ritonavir and cobicistat and decrease drug-drug interactions with tacrolimus (8,9).  
 
In treatment naïve adults with HIV-1 infection, switching from DTG, abacavir, and lamivudine to 
BIC/F/TAF proved to be a safe and efficacious option for the treatment of HIV-1 infection (1). The 
pharmacokinetics of BIC/F/TAF were assessed in this study, and the mean trough concentrations of 
BIC were 14 times higher than the protein-adjusted 95% effective concentration against wild type 
HIV-1 virus.  
 
There is no current data about the pharmacokinetics of BIC/F/TAF in renal transplant recipients 
or the interactions of BIC/F/TAF with tacrolimus. Previous work has demonstrated sustained, zero-
order, linear, release pharmacokinetic characteristics of TAF (10,11). TAF is metabolized via CES1 in 
hepatocytes, cathepsin A in PBMCs, and minimally with CYP3A. Tenofovir plasma levels significantly 
increase when administered to subjects with moderate to severe renal impairment, such that the 
dosing interval is adjusted in patients with baseline creatinine clearance below 50 mL/min based on 
modeling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with 
varying degrees of renal impairment (12).  
 
TAF is hydrolyzed within cells to form tenofovir (major metabolite), which is phosphorylated to 
the active metabolite, tenofovir diphosphate. In vitro studies have shown that TAF is metabolized to 
tenofovir by CES1 in hepatocytes, and by cathepsin A in PBMCs and macrophages. Whether 
tenofovir can accumulate and lead to nephrotoxicity in conjunction with tacrolimus after tenofovir 


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alafenamide administration is not known. Moreover, the long-term renal safety of tenofovir 
alafenamide in HIV+ renal transplant recipients receiving tacrolimus is not known. 
 
Dried blood spots have been used to determine markers of recent dosing and measures of anti-
retroviral adherence (13,14). Comparison of tenofovir and FTC in dried blood spot versus plasma 
indicated that dried blood spot can be used as a plasma alternative for pharmacokinetic analyses in 
vivo (15). Measurement of intracellular TAF levels has not been done in the HIV+ renal transplant 
population. We will therefore incorporate the dried blood spot method and PBMC method to 
determine intracellular TAF levels and monitor adherence in the renal transplant population. 
 
We therefore will determine concentrations of BIC, FTC, and TAF in serial samples of plasma and 
peripheral blood mononuclear cells over the course of 48 weeks in HIV+ renal transplant recipients 
(Section 6.1). 
 
Preservation of renal function and graft survival is of primary importance in this HIV-infected 
renal transplant population, challenged by drug-drug interactions between ARV regimens and anti-
rejection medications. In the 112 study (5), switching to E/C/F/TAF had no change in estimated or 
actual GFR and proteinuria, proximal renal tubular function, and BMD significantly improved over 48 
weeks. In patients with eGFR <50 mL/min, adverse events were similar in grade and frequency to 
patients with GFR>50 mL/min. BIC/F/TAF has demonstrated high rates of virologic suppression and 
no treatment-emergent resistance through 48 weeks in phase 3 clinical trials among treatment 
naïve adults and among virologically suppressed adult patients who switched ARV regimens. 
Therefore, BIC/F/TAF promises to be an important ARV regimen to be studied in HIV+ post renal 
transplant patients, including drug-drug interactions with anti-rejection agents, especially 
tacrolimus. Pharmacokinetic studies, and drug-drug interactions are important to study in this 
unique population, as well as the efficacy, safety and tolerability of BIC/F/TAF. 
 
In this single arm, open-label, switch study, we propose to switch virally suppressed HIV+ adults 
post-renal transplant to BIC/F/TAF and follow the subjects for 48 weeks to evaluate the efficacy, 
safety and tolerability of BIC/F/TAF, plus a 6 month follow-up. Health related quality of life 
outcomes are important in the evaluation of ARV treatment strategies, especially in the HIV+ renal 
transplant population. BIC/F/TAF and DTG-based regimens have been compared in treatment-naïve 
and HIV-1 suppressed adults, showing non-inferior efficacy and less drug-related adverse events in 
BIC/F/TAF arms compared to DTG-based regimens. To better understand the patients’ experience 
with BIC/F/TAF post renal transplant, we will be using a specific quality of life questionnaire 
(Attachment 1). We hypothesize that BIC/F/TAF will be an important addition to the management of 
HIV+ post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby 
decreasing the pill burden in this unique population. 
 
  
2.1  Risk/Benefit Assessment  
 
 
 
2.1.1 
Known Potential Risks 
The most common adverse reactions with BIC/F/TAF (incidence greater than or equal to 
5%, all grades) are diarrhea, nausea, and headache. Other potential warnings and 
precautions include the immune reconstitution syndrome, new onset or worsening 
renal impairment, and lactic acidosis/severe hepatomegaly with steatosis. 


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2.1.2 
Known Potential Benefits  
 
BIC/F/TAF has demonstrated high rates of virologic suppression and no treatment-
emergent resistance through 48 weeks in phase 3 clinical trials among treatment naïve 
adults and among virologically suppressed adult patients who switched ARV regimens. 
BIC/F/TAF also has lower pill burden than other anti-retroviral regimens, due to a one-
pill composition.  
 
 
3. Study Design 
 
3.1 Overall Design 
 
We hypothesize that BIC/F/TAF will be efficacious and safe in the management of HIV+ post renal 
transplant patients, and will have few adverse reactions and drug-drug interactions with tacrolimus 
in this population.  
 
Eighteen subjects will be enrolled in this Phase IV, single arm, open-label, single-site, switch study. In 
this study, virally suppressed HIV+ adults will be switched post-renal transplant from their current 
anti-retroviral regimen to BIC/F/TAF and will be followed for 48 weeks with a 6 month follow-up 
(Section 6.1). Informed consent will be obtained before starting the study (Section 6.1). 
 
Patients will have bloodwork completed throughout the study, as shown in the Schedule of 
Assessments (Section 6.1).  
 
A health-related quality of life questionnaire (Appendix) will be administered to each patient to 
assess satisfaction with a one pill regimen as well as adverse events (Section 6.1).  
 
Pharmacokinetic (PK) studies will be assessed at Week 12 when the renal function is stable (decided 
by PI). Intracellular TAF levels by dried blood spot will be collected during the Week 12 visit as well 
as Week 24, Week 36, Week 48, Month 6 Follow-up. Intracellular TAF levels by PBMC will be 
collected once during the Week 12 visit. An intensive pharmacokinetic day will take place at the 
Week 12 visit. This bloodwork is outlined in Section 6.1. Bloodwork for the intracellular TAF level 
testing and pharmacokinetic testing will be stored and sent to Dr. Peter Anderson at the University 
of Colorado's Antiviral Laboratory. (14-16) 
 
Note: Patients switched post-renal transplant from their current anti-retroviral regimen to 
BIC/F/TAF prior to identification for this study may also be enrolled. This group will be referred to as 
“Group 2”. Pharmacokinetic testing for Group 2 subjects will be completed once each Group 2 
subject's tacrolimus levels are stable as per the Principal Investigator for 2-4 weeks. All standard of 
care lab values and concomitant medications will be collected from Group 2 subjects for 60 days 
prior to and after the Biktarvy switch date and for the duration of Biktarvy therapy. Any adverse 
events related to Biktarvy prior to enrollment will be recorded. 
 
Sample Collection 
Samples include plasma and peripheral blood mononuclear cells (PBMC). Blood is collected in EDTA 
tubes for plasma separation. CPT vacutainers are used to isolate PBMC, which are counted with an 


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automated countess cytometer (InvitrogenTM, Thermo Fisher Scientific Corporation, Carlsbad, CA) 
and lysed. BIK, F, and TAF in plasma are assayed using a validated LC/MS/MS methodology with a 
lower limit of quantification (LLOQ) of 10 ng/mL (16). 
 
Determination of Pharmacokinetic Variables 
The pharmacokinetic variables for BIC/F/TAF are calculated from the concentration-time data using 
noncompartmental methods. The peak drug concentration (Cmax) and time of peak drug 
concentration are obtained directly from the observed data. The terminal elimination rate constant 
(kel) is obtained from a log-linear regression of the plasma concentration compared to time data in 
the terminal post distribution phase. The elimination half-life (t1/2) is calculated from 0.693/kel. The 
area under the plasma drug concentration-versus-time curve (AUC0–24) and the area under the 
moment curve from 0 to 24 h (AUMC0–24) are calculated by the log-linear trapezoidal rule. The area 
under the plasma drug concentration-versus-time curve from time zero to time infinity (AUC0–) is 
obtained from the following equation: AUC0–24 • Ct/kel, where Ct is the last measurable 
concentration and kel is the terminal elimination rate constant. The total body clearance (CL) is 
obtained from the equations dose/AUC0– and dose/AUC0–24 (presumed steady state, where 24 h 
is the dosing interval), respectively. The volume of distribution (Vd) is calculated as follows: Vd= 
CL/kel. The steady-state volume of distribution (Vss) is calculated from the product of CL and the 
mean residence time. The mean residence time is obtained from the following equation: (AUMC0–
/AUC0–) T/2, where AUMC0– is extrapolated from [(Ct x t)/kel x Ct/kel2] and where T is the 
infusion time, all other terms having been previously defined. 
 
Statistical Analyses and Sample Size 
This is a pilot study of the efficacy, safety, and pharmacokinetics of BIC/F/TAF in HIV+ renal 
transplant recipients. Sample size is based upon feasibility of enrolling the current cohort of patients 
on the WCM/NYPH renal transplant service who are currently receiving antiretroviral therapy. 
Among the 37 HIV+ renal transplant recipients who are followed at NYPH and who are currently 
eligible for the study, we project that 20 patients will enroll into this study and complete treatment. 
 
We hypothesize that in the transition from a standard antiretroviral regimen to a BIC/F/TAF 
regimen, there would be high probability of a sustained suppression of HIV- RNA (1). In the 
randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority clinical trial of 
switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus 
abacavir and lamivudine in virologically suppressed adults with HIV-1 by Molina et al, the primary 
endpoint was the proportion of participants with plasma HIV-1 RNA of 50 copies per mL or higher at 
week 48 that fulfilled the prespecified non-inferiority margin of 4%, where three (1%) of 282 in the 
bictegravir group had HIV-1 RNA of 50 copies per mL or higher at week 48 versus one (<1%) of 281 
participants in the dolutegravir group (difference 0·7%, 95·002% CI -1·0 to 2·8; p=0·62). 
 
The number of 20 subjects who are projected for enrollment and study completion will provide 
sufficiently robust data for pharmacokinetic studies to yield a coefficient of variation of <15%, which 
will permit a robust analysis and model development.  
 
Outcome variables and adverse events will be reported using descriptive statistics, including means, 
medians, ranges, and standard errors. 
 
The relationship between renal function, tacrolimus levels, BIC/F/TAF plasma concentrations, and 
intracellular concentrations of TAF will be determined by linear regression analysis. 


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4. Subject Selection 
 
4.1 Study Population 
 
Virally suppressed HIV+ adults post-renal transplant who meet the inclusion and exclusion criteria 
will be eligible for participation in this study.  
 
4.2 Inclusion Criteria 
1. Be ≥18 years of age on day of signing informed consent. 
2. Have documented positive results for human immunodeficiency virus (HIV) antibody (HIV-Ab) 
test at time of enrollment. 
3. Received a previous renal transplant. 
4. Must have controlled HIV infection, defined as HIV-1 RNA < 50 copies/ml for ≥ 3 months prior to 
enrollment. 
4.3 Exclusion Criteria  
1. Has renal function of CrCl <30 mL/min at time of enrollment. CrCl will be calculated using the 
Cockcroft-Gault equation using the most recently obtained and available serum creatinine value 
collected. 
2. BIC/F/TAF is the only antiretroviral therapy ever used for treatment of HIV infection. 
3. Is allergic to any of the HIV meds in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir 
alafenamide). 
4. Pregnant or breastfeeding. 
5. Is currently taking dofetilide or rifampin. 
6. Has severe hepatic impairment (Child-Pugh Class C). 
7. ALT or AST > 5 x ULN. 
 
4.4 Lifestyle Considerations  
 
 
No lifestyle restrictions are required based on study procedures. 
 
4.5 Screen Failures  
 
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently entered in the study. A minimal set of screen failure information is required to ensure 
transparent reporting of screen failure participants, to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, and 
any serious adverse event (SAE). 
 
Individuals who do not meet the criteria for participation in this trial (screen failure) because of a 
renal function value exclusion may be rescreened. Rescreened participants should be assigned the 
same participant number as for the initial screening. 
 


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4.6 Strategies for Recruitment and Retention 
 
 
The Renal Transplant Program works in close collaboration with the Transplant/Oncology 
Infectious Diseases Program, including clinical research trials. Recruitment will primarily rely on 
referrals from the Renal Transplant Program and/or existing patients of the infectious disease 
investigators. Recruitment will primarily be sources from outpatient clinics, such as the 
Infectious Disease Clinic and the Renal Transplant Clinic. The target enrollment is 20 subjects. 
Monthly enrollment logs will be collected.  
 
Subjects will be compensated $40 per outpatient visit, as a stipend to cover travel costs. For 
visits that require pharmacokinetic blood sampling, subjects will be compensated $200 per 
outpatient visit, as a stipend to cover travel costs and time.  
 
 
5. Registration Procedures  
 
5.1 Subject Registration  
 
Subjects will be registered within the WRG-CT as per the standard operating procedure for 
Subject Registration.  
 
 
 
 
6. Study Procedures  
 
Study procedures are outlined in the Schedule of Assessments (Section 6.1)


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6.1 Schedule of Assessments* 
Activity 
D 
1 
D 
3 
D 
8 
D 
15 
D 
22 
W 
4 
W 
8 
W 
12 
W 
16 
W 
24 
W 
32 
W 
36 
W 
48 
FU –  
M3 
FU – 
M6 
UVk 
Visit Window (Days) 
±1 
±3 
±7 
 
Informed consent  
X a 
  
  
  
  
  
  
  
  
  
  
  
  
  
 
 
Inclusion/Exclusion Criteria  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Research study visit, including weight 
X 
Xj 
Xj 
Xj 
Xj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical exam 
X 
  
  
  
  
Xb 
  
Xb 
  
X 
  
Xb 
X 
Xb 
Xb 
Xb 
Questionnaire booklet administration 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Questionnaire completionc 
  
  
  
  
  
X 
  
X 
  
X 
  
X 
X 
X 
X 
X 
Dispense study medication 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
T-lymphocytes, HIV viral load 
X 
  
  
  
  
X 
  
X 
  
X 
  
X 
X 
X 
X 
X 
HIV-resistance testing 
 
As needed, as per investigatord 
 
Tacrolimus level 
X 
Xj 
Xj 
Xj 
Xj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
BUN, creatinine 
  
Xj 
Xj 
Xj 
Xj 
As needed, as per investigatore 
Clinical Safety Labsf 
X 
  
  
  
  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
TAF levels, intracellular (dried blood spot)g 
  
  
  
  
  
  
  
X 
  
X 
  
X 
X 
 
X 
X 
TAF levels, intracellular (PBMC)h 
  
  
  
  
  
  
  
X 
  
  
  
  
  
  
 
 
Pharmacokinetics i 
  
  
  
  
  
  
  
X 
  
  
  
  
  
  
 
 
Abbreviations: D = Day; W = Week; M = Month; FU = Follow-up; UV = Unscheduled Visit 
*If services outside of the study (standard of care, or "SOC") are completed for a patient during the study period, only the research-related tests and procedures 
will be billed to the study. SOC tests and procedures are expected throughout the study period for this population. 
 
a Informed consent may be obtained up to 2 months before D1. Subjects enrolled into Group 2 will begin the study schedule at the Day 1 visit and will then be inserted 
into the Schedule of Assessments at the discretion of the Principal Investigator based on stability of the subject’s HIV viral load and tacrolimus levels. 
b If there are complications, as deemed by the investigator, a physical exam will be conducted at this time point. If institutional restrictions limit outpatient visits, the 
most recent physical exam completed by the primary care physician will be used to avoid direct contact or exposure of patients. 
c Questionnaires may be completed by phone or returned by mail, if institutional restrictions limit outpatient visits. 
d HIV resistance testing will be performed if there are two consecutive breakthrough HIV viral loads >50 copies/mL, spaced 4-6 weeks apart.  
e Additional BUN and/or creatinine labwork may be drawn at these timepoints, if deemed necessary for safety purposes by the investigator. 
f Clinical Safety Labs include: CBC, complete metabolic panel, urinalysis, eGFR, urine protein/creatinine ratio, urine albumin/creatinine ratio, phosphorus, retinol 
binding protein, and beta 2 microglobulin. For subjects enrolled in Group 2, all standard of care lab values and concomitant medications will be collected for 60] days 
prior to the Biktarvy switch date and the duration of Biktarvy therapy will also be recorded. 
g Three samples will be collected on W12 at 0, 4, and 24 hours (the 24 hour time point is optional, if feasible), and 1 sample will be collected at visits W24, W36, and 
W48, and FU – M6. Stored samples will be sent to Dr. Peter Anderson at the University of Colorado's Antiviral Laboratory. 
h Three samples will be collected on W12 at 0, 4, and 24 hours (the 24 hour time point is optional, if feasible). Stored samples will be sent to Dr. Peter Anderson at the 
University of Colorado's Antiviral Laboratory. 


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i Six samples will be collected on W12 at 0, 0.5, 1, 2, 4, and 24 hours (the 24 hour time point is optional, if feasible). Pharmacokinetic testing for Group 2 subjects will 
be completed once the subject's tacrolimus levels are stable as per the Principal Investigator for 2-4 weeks.  
j The study visits and bloodwork at these timepoints will be optional, to be completed as needed, as per the investigator. 
k If a subject needs to stop treatment as per the Data and Safety Monitoring Plan (Section 12), the subject will be seen as soon as possible for an Unscheduled Visit and 
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Informed consent will be obtained on Day 1 or up to 2 months prior to Day 1, before starting the study 
(switch day) (Section 6.1). 
 
Patients will have bloodwork completed throughout the study, as shown in the Schedule of Assessments 
(Section 6.1).  
 
Pharmacokinetic (PK) studies will be assessed at Week 12 when the renal function is stable (decided by 
PI). Intracellular TAF levels by dried blood spot will be collected during the Week 12 visit at 0, 4, and 24 
hours post-dose (the 24 hour time point is optional, if feasible). Additionally, 1 sample will be collected 
at Week 24, Week 36, Week 48, Month 6 Follow-up. Over the course of the study, 7 dried blood spot 
collections will be completed per patient. Intracellular TAF levels by PBMC will be collected once during 
the Week 12 visit at 0, 4, and 24 hours post-dose (the 24 hour time point is optional, if feasible). An 
intensive pharmacokinetic day will take place at the Week 12 visit, during which up to 7 samples will be 
collected at 0, 0.5, 1, 2, 4 and 24 hours post-dose (the 24 hour time point is optional, if feasible). This 
bloodwork is outlined in Section 6.1. Bloodwork for the intracellular TAF level testing and 
pharmacokinetic testing will be stored and sent to Dr. Peter Anderson at the University of Colorado's 
Antiviral Laboratory. (14-16) 
 
A health-related quality of life questionnaire (Appendix) will be administered to each patient to assess 
satisfaction with a one pill regimen as well as adverse events (Section 6.1).  
 
If a subject needs to stop treatment as per the Data and Safety Monitoring Plan (Section 12), the subject will 
be seen as soon as possible for an Unscheduled Visit and will continue to be followed for the duration of the 
study as per the Schedule of Assessments for non-terminated patients. 
 
If services outside of the study (standard of care, or "SOC") are completed for a patient during the study 
period, only the research-related tests and procedures will be billed to the study, regardless of study 
visit date overlap. SOC tests and procedures are expected throughout the study period for this 
population. 
 
Sample Collection 
 
Samples include plasma and peripheral blood mononuclear cells (PBMC). Blood is collected in EDTA 
tubes for plasma separation. CPT vacutainers are used to isolate PBMC, which are counted with an 
automated countess cytometer (InvitrogenTM, Thermo Fisher Scientific Corporation, Carlsbad, CA) and 
lysed. BIK, F, and TAF in plasma are assayed using a validated LC/MS/MS methodology with a lower limit 
of quantification (LLOQ) of 10 ng/mL (16). 
 
 
7. Study Intervention 
 
 
7.1 Study Intervention/Device Description  
 
BIC/F/TAF is a three-drug fixed dose combination product containing 50 mg of bictegravir (BIC), 200 
mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of 
BIC/F/TAF is one tablet taken orally once daily with or without food in adults. BIC/F/TAF should be 
stored below 86°F (30°C). 
 


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7.2 Availability 
 
BIC/F/TAF is an FDA-approved agent, to be supplied to investigators by Gilead. 
 
7.3 Acquisition and Accountability  
 
 
 
The investigator, or a responsible party designated by the investigator, will maintain a careful record 
of the inventory and disposition of all agents/device received from Gilead on a Drug Accountability 
Record Form.  
 
 
8. Data Collection 
 
The data collection plan for this study is to utilize REDCap to capture all treatment, toxicity, efficacy, and 
adverse event data for all enrolled subjects.  
 
8.1 REDCap 
 
REDCap (Research Electronic Data Capture) is a free data management software system 
that is fully supported by the Weill-Cornell Medical Center CTSC. It is a tool for the 
creation of customized, secure data management systems that include Web-based data-
entry forms, reporting tools, and a full array of security features including user and 
group based privileges, authentication using institution LDAP system, with a full audit 
trail of data manipulation and export procedures. REDCap is maintained on CTSC-owned 
servers that are backed up nightly and support encrypted (SSL-based) connections. 
Nationally, the software is developed, enhanced and supported through a multi-
institutional consortium led by the Vanderbilt University CTSA. 
 
9. Regulatory Considerations 
 
9.1 Institutional Review Board/Ethics Committee Approval  
 
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained, before study initiation.  
Before initiation of the study, the protocol, the ICF, other written material given to the patients, 
and any other relevant study documentation will be submitted to the appropriate Ethics 
Committee. Written approval of the study and all relevant study information must be obtained 
before the study center can be initiated or the IP is released to the Investigator. Any necessary 
extensions or renewals of IRB approval must be obtained for changes to the study, such as 
amendments to the protocol, the ICF, or other study documentation. The written approval of the 
IRB together with the approved ICF must be filed in the study files.  
The Investigator will report promptly to the IRB any new information that may adversely affect 
the safety of the patients or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IRB as required. On completion of the study, the IRB will be 
notified that the study has ended.  
 
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be signed and dated by the original protocol approving signatories. All protocol amendments will 
be submitted to the relevant institutional IRB for approval before implementation, as required by 
local regulations. The only exception will be when the amendment is necessary to eliminate an 
immediate hazard to the trial participants. In this case, the necessary action will be taken first, 
with the relevant protocol amendment following shortly thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites, as applicable. Weill 
Cornell Medicine must approve all consent form changes prior to local IRB submission.  
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.  
 
9.2 Ethical Conduct of the Study  
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements.  
 
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 
 
9.3 Informed Consent 
 
The investigator or qualified designee must obtain documented consent according to ICH-GCP 
and local regulations, as applicable, from each potential subject or each subject’s legally 
authorized representative prior to participating in the research study. Subjects who agree to 
participate will sign the approved informed consent form and will be provided a copy of the signed 
document.  
 
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB requirements, applicable 
laws and regulations. 
 
9.4 Compliance with Trial Registration and Results Posting Requirements  
 
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
 
9.5 Record Retention 
 


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Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced. After completion of the study, all documents and data 
relating to the study will be kept in an orderly manner by the Investigator in a secure study file. 
Essential documents should be retained for 2 years after the final marketing approval in an ICH 
region or for at least 2 years since the discontinuation of clinical development of the IP. In 
addition, all subjects medical records and other source documentation will be kept for the 
maximum time permitted by the hospital, institution, or medical practice.  
 
10. Statistical Considerations 
 
10.1 Study Design/Endpoints 
 
We hypothesize that in the transition from a standard antiretroviral regimen to a BIC/F/TAF 
regimen, there would be high probability of a sustained suppression of HIV- RNA (1). In the 
randomized, double-blind, multicenter, active-controlled, phase 3, non-inferiority clinical trial of 
switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir plus 
abacavir and lamivudine in virologically suppressed adults with HIV-1 by Molina et al, the primary 
endpoint was the proportion of participants with plasma HIV-1 RNA of 50 copies per mL or higher at 
week 48 fulfilled the prespecified non-inferiority margin of 4%, where three (1%) of 282 in the 
bictegravir group had HIV-1 RNA of 50 copies per mL or higher at week 48 versus one (<1%) of 281 
participants in the dolutegravir group (difference 0·7%, 95·002% CI-1·0 to 2·8; p=0·62). 
 
The number of 20 subjects who are projected for enrollment will provide sufficiently robust data for 
pharmacokinetic studies to yield a coefficient of variation of <15%, which will permit a robust 
analysis and model development. Outcome variables and adverse events will be reported using 
descriptive statistics, including means, medians, ranges, and standard errors. The relationship 
between renal function, tacrolimus levels, BIC/F/TAF plasma concentrations, and intracellular 
concentrations of TAF will be determined by linear regression analysis.  
 
Expected Outcomes:  
1. We expect sustained suppression of the HIV viral load throughout the study. 
2. We expect that BIC/F/TAF will be well tolerated in the HIV+ renal transplant population with 
minimal adverse events and preservation of renal function with stable tacrolimus levels. 
3. Plasma concentrations of BIC/F/TAF will follow those reported in HIV+ non-renal transplant 
recipients and drug/drug interactions with tacrolimus will be minimal, allowing easy adjustment 
with minimal detrimental effects on renal function. 
 
 
11. Adverse Events 
 
11.1 Adverse Event Definition 
 
An adverse event (also referred to as an adverse experience) can be any unfavorable and 
unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally 
associated with the use of a drug, and does not imply any judgment about causality. An adverse 
event can arise with any use of the drug (e.g., off-label use, use in combination with another 
drug) and with any route of administration, formulation, or dose, including an overdose.  
 
 
 
 


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11.2 Recording of Adverse Events 
 
All adverse events will be recorded on a subject specific AE log. The AE log will be maintained by 
the research staff and kept in the subject’s research chart.  
 
Subjects enrolled in Group 2 will have pre-enrollment adverse events recorded, if they are 
related to Biktarvy following their switch from previous antiretroviral therapy. 
 
 
11.3 
Reporting of AE to WCM IRB 
 
All AEs occurring on this study will be reported to the IRB according to the IRB policy, which can 
be accessed via the following link: 
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immediate_Reporting_Poli
cy.pdf.  
 
11.4 
Reporting of SAE to IRB 
 
All SAEs occurring on this study will be reported to the IRB according to the IRB policy, which can 
be accessed via the following link:  
http://researchintegrity.weill.cornell.edu/forms_and_policies/forms/Immediate_Reporting_Poli
cy.pdf.  
 
 
11.5 
Reporting of SAE to Gilead  
 
Institution will send Gilead copies of any and all serious adverse event reports filed with 
the FDA or other applicable regulatory authorities, as well as copies of any 
correspondence with the FDA or other applicable regulatory authorities, regarding any 
and all serious adverse events, irrespective of association with the Study Drug(s) in the 
course of the Clinical Trial, within 3 business days of such report or correspondence 
being sent to the FDA or other applicable regulatory authorities.  
 
 
11.6 AE/SAE Follow Up 
 
All SAEs and AEs reported during this study will be followed until resolution or until the 
investigator confirms that the AE/SAE has stabilized and no more follow-up is required. This 
requirement indicates that follow-up may be required for some events after the subject 
discontinues participation from the study.  
 
12. Data and Safety Monitoring Plan (DSMP) 
The WCM DSMB will be used for this investigator-initiated study. The following information will be 
submitted to the WCM DSMB every 6 months from the time of the first enrollment: 
 
Laboratory results 
• 
T-lymphocytes, HIV viral load: From Day 1, Week 4, Week 12, Week 24, Week 36, Week 48, 3-
month Follow-up, and 6-month Follow-up 
• 
Select clinical safety labs1: From Day 1 and all visits from Week 4 through 6-month Follow-up 


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• 
BUN, creatinine: From Days 3 through Day 22, and if needed at additional time points, as per 
investigator 
• 
Tacrolimus levels: All time points 
• 
Any HIV-resistance testing needed, as per investigator 
1 Clinical Safety Labs include: CBC, complete metabolic panel, urinalysis, eGFR 
 
Adverse Events and Stopping Rules 
The following adverse events will be submitted to the WCM DSMB and may cause the subject to 
terminate protocol treatment: 
1. Severe drug reaction, including rash or fever (as determined by the PI) 
2. Inability to control tacrolimus levels, as defined by the primary renal transplant provider, which 
may lead to renal graft failure 
3. ALT or AST > 5 x ULN 
4. Virologic failure, as determined by the Principal Investigator, which would be defined as: On-
treatment HIV-1 RNA ≥50 copies/mL twice sequentially, separated by 4-6 weeks 
5. Development of documented resistance to BIC/FTC/TAF 
 
Renal dysfunction requiring evaluation is defined as a decrease in creatinine clearance to CrCl < 30 
mL/min. The evaluation of renal dysfunction will be completed by the primary renal transplant team, in 
conjunction with the PI.  
 
If the CrCl is below 30 mL/min, the BIC/F/TAF will be held and an evaluation will be performed by the 
primary renal transplant physician in conjunction with the PI. The evaluation of the cause will be 
explored by the primary renal transplant physician in conjunction with the PI. The patient will be 
discontinued from the study at the discretion of the PI, after discussion with the primary renal 
transplant physician, if deemed necessary. 
 
WCM IRB policies will be followed for this study, including the Immediate Report Policy. Any SAEs will be 
reported to the IRB following these policies, and will also be reported to the funding source (Gilead 
Sciences, Inc.) within 3 business days of the study team learning of the SAE. The WCM DSMB 
comments/review will be submitted to the IRB at the time of continuing review and submitted to the 
funding source (Gilead Sciences, Inc.) at the time of each WCM DSMB completion. 
 
 
 
 
 
 
 


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References 
 
1. Molina JM, Ward D, Brar I, Mills A et al. Switching to fixed-dose bictegravir, emtricitabine, and 
tenofovir alafenamide from dolutegravir plus abacavir and lamivudine in virologically suppressed 
adults with HIV-1: 48 week results of a randomised, double-blind, multicentre, active-controlled, 
phase 3, non-inferiority trial. Lancet HIV 5(7): e357-e365, 2018. 
 
2. Gallant J, Lazzarin A, Mills A, Orkin C, et al Bictegravir, emtricitabine, and tenofovir alafenamide versus 
dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a 
double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet 390: 2063–
72, 2017. 
 
3. Sax PE, DeJesus E, Crofoot G, Ward D, et al. Bictegravir versus dolutegravir, each with emtricitabine 
and tenofovir alafenamide, for initial treatment of HIV-1 infection: a randomised, double-blind, 
phase 2 trial. Lancet HIV 4(4):e154-e160, 2017. 
 
4. Orkin C, Molina JM, Negredo E, Arribas JR, Gathe J, et al. Efficacy and safety of switching from boosted 
protease inhibitors plus emtricitabine and tenofovir disoproxil fumarate regimens to single-tablet 
darunavir, cobicistat, emtricitabine, and tenofovir alafenamide at 48 weeks in adults with 
virologically suppressed HIV-1 (EMERALD): a phase 3, randomised, non-inferiority trial. Lancet HIV 
5(1):e23-e34, 2018. 
 
5. Pozniak A, Arribas JR, Gathe J, Gupta SK, et al. Switching to Tenofovir Alafenamide, Coformulated 
With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-
Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic 
Syndr. 71(5):530-7, 2016. 
 
6. Deeks, ED. Bictegravir/Emtricitabine/Tenofovir Alafenamide: A Review in HIV-1 Infection. Drugs 
78(17):1817-1828, 2018. 
 
7. Eron JJ, Lelievre J-D, Kalayjian R, Slim J, et al. Safety and Efficacy of E/C/F/TAF in HIV-Infected Adults 
on Chronic Hemodialysis (Abstract, poster 732 presented at CROI 2018). 
 
8. Stock PG, Barin B, Murphy B, Hanto D, Diego JM, et al. Outcomes of kidney transplantation in HIV-
infected recipients. N Engl J Med. 363(21): 2004-14, 2010. 
 
9. Locke JE, Mehta S, Reed RD, et al. A national study of outcomes among HIV-infected kidney transplant 
recipients. JASN 26(9): 2222-2229, 2015. 
 
10.Gunawardana M et al. Pharmacokinetics of long-acting tenofovir alafenamide (GS-7340) subdermal 
implant for HIV prophylaxis. Antimicrob Agents Chemother. 59:3913-9, 2015. 
 
11.Kraft JC, et al. Long-acting combination anti-HIV drug suspension enhances and sustains higher drug 
levels in lymph node cells than in blood cells and plasma. AIDS 31:765-770, 2017. 
 
12. Pharmacoeconomic Review Report: Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) 
(BIC/F/TAF): (Gilead Sciences Canada, Inc.): Indication: A complete regimen for the treatment of HIV-
1 infection in adults with no known substitution associated with resistance the individual 


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components of BIC/F/TAF [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in 
Health; 2018 Oct. Available from: https://www.ncbi.nlm.nih.gov/books/NBK539546/ 
 
13. Castillo-Mancilla JR, Zheng JH, Rower JE, Meditz A, Gardner EM, Predhomme J, Fernandez C, 
Langness J, Kiser JJ, Bushman LR, Anderson PL. Tenofovir, Emtricitabine, and Tenofovir Diphosphate 
in Dried Blood Spots for Determining Recent and Cumulative Drug Exposure. AIDS Res Hum 
Retroviruses. 29(2):384-90, 2013. 
 
14. Castillo-Mancilla J, Seifert S, Campbell K, Coleman S, et al. Emtricitabine-Triphosphate in Dried Blood 
spots as a Marker of Recent Dosing. Antimicrobial Agents and Chemotherapy 60(11): 6692-6697, 
2016. 
15. Zheng J-H, Guidaa LA, Rowera C, Castillo-Mancillab J, Meditzb A, et al. Quantitation of tenofovir and 
emtricitabine indried bloodspots 19-(DBS) with LC–MS/MS. Journal of Pharmaceutical and 
biomedical Analysis 88:144–151, 2014. 
16. Anderson PL, Kiser JJ, Gardner EM, Rower JE, Meditz A, Grant RM. Pharmacologic considerations for 
tenofovir and emtricitabine to prevent HIV infection. J Antimicrob Chemother. 66: 240-250, 2011.


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Appendix. HIV Treatment Satisfaction Questionnaire
 


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HIV TREATMENT SATISFACTION QUESTIONNAIRE 
 
 
SUBJECT IDENTIFIER _______________________ 
 
DATE _________________ 
 
 
The following questions are concerned with your medical treatment for HIV and your 
experience over the past few weeks. Please answer each question by circling a number on 
each of the scales. 
 
 
1. How satisfied are you with your current treatment? 
  
 very satisfied 6 5 4 3 2 1 0 very dissatisfied 
 
 
2. How well controlled do you feel your HIV has been recently? 
 
 very well controlled 6 5 4 3 2 1 0 very poorly controlled 
 
 
3. How satisfied are you with any side effects of your present treatment? 
 
 very satisfied 6 5 4 3 2 1 0 very dissatisfied 
 
 
4. How satisfied are you with the demands made by your current treatment? 
 
very satisfied 6 5 4 3 2 1 0 very dissatisfied 
 
 
5. How convenient have you been finding your treatment to be recently? 
 
 very convenient 6 5 4 3 2 1 0 very inconvenient 
 
 
6. How flexible have you been finding your treatment to be recently? 
 
 very flexible 6 5 4 3 2 1 0 very inflexible 
 
 
 


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7. How satisfied are you with the extent to which the treatment fits in with your lifestyle? 
  
 very satisfied 6 5 4 3 2 1 0 very dissatisfied 
 
 
8. Would you recommend your present treatment to someone else with HIV? 
 
 yes, I would recommend 6 5 4 3 2 1 0 no, I would definitely not recommend  
 
 
9. How satisfied would you be to continue with your present form of treatment? 
 
 very satisfied 6 5 4 3 2 1 0 very dissatisfied 
 
 
 
Please make sure that you have circled one number on each of the scales. 
 
Thank you for taking the time to complete this questionnaire.