Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) After Renal Transplant

July 25, 2025 updated by: Weill Medical College of Cornell University

The Efficacy, Safety, and Tolerability of Switching to a Bictegravir (BIC)/Emtricitabine(FTC)/Tenofovir Alafenamide (TAF) Regimen in Virally Suppressed Human Immunodeficiency Viruses (HIV)-Positive Patients Post-Renal Transplant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least 18 years old on day of signing informed consent
  • Positive for human immunodeficiency virus (HIV)
  • Received a previous renal transplant
  • Must have controlled HIV infection for at least 3 months prior to enrollment

Exclusion Criteria:

  • Received a kidney from a donor who was HIV positive (unless a false positive)
  • Currently taking BIC/F/TAF for treatment of HIV
  • Has allergies to any of the HIV medications in BIC/F/TAF (bictegravir, emtricitabine, or tenofovir alafenamide)
  • Currently taking dofetilide or rifampin
  • Is pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF)
Participants receive a BIC/F/TAF tablet orally once daily with or without food.
Drug: BIC/F/TAF 50Mg-200Mg-25Mg Tablet
A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.
Other Names:
  • Biktarvy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml
Time Frame: Up to week 48 (End of Study)
HIV viral loads will be obtained from lab reports.
Up to week 48 (End of Study)
Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)
Time Frame: Up to week 48 (End of study)
Up to week 48 (End of study)
Intracellular TAF Levels as Measured by Dried Blood Spot
Time Frame: 12 weeks
Fmol/punch refers to the concentration of a substance, measured in femtomoles per a specific size of a dried blood spot (DBS) punch.
12 weeks
Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)
Time Frame: 12 weeks
pmol/10^6 cells refers to the amount of a particular substance (in picomoles) per one million cells
12 weeks
Renal Function as Measured by Blood Urea Nitrogen (BUN)
Time Frame: 24 weeks, 48 weeks (End of study)
24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine
Time Frame: 24 weeks, 48 weeks (End of study)
24 weeks, 48 weeks (End of study)
Renal Function as Measured by Creatinine Clearance
Time Frame: 24 weeks, 48 weeks (End of study)
24 weeks, 48 weeks (End of study)
Renal Function as Measured by Estimated Glomerular Filtration Rate (eGFR)
Time Frame: 24 weeks, 48 weeks (End of study)
24 weeks, 48 weeks (End of study)
Tacrolimus Levels
Time Frame: 12 weeks, 24 weeks, 48 weeks (End of study)
12 weeks, 24 weeks, 48 weeks (End of study)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline CD4+ T Lymphocyte Numbers Post Renal Transplant
Time Frame: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
Number of CD4+ T lymphocyte counts will be obtained from lab reports
Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
Change From Baseline CD4+ T Lymphocyte Percentages Post Renal Transplant
Time Frame: Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
CD4+ T lymphocyte percentages will be obtained from lab reports
Day 1 (Baseline), Week 4, Week 12, Week 24, Week 36, Week 48 (End of study)
Number of Subjects With Rejection of the Kidney Transplant, Post Renal Transplant
Time Frame: up to 48 weeks (End of study)
Data for kidney graft rejection will be extracted from biopsy confirmed rejections.
up to 48 weeks (End of study)
Participant Satisfaction With Reduced Pill Burden and Adverse Events (Tolerability) Measured by the Health-related Quality of Life Questionnaire
Time Frame: Week 24, Week 48 (End of study)
Satisfaction will be measured by the self-reporting health-related quality of life questionnaire ranging from 0 to 6 with higher scores indicating greater satisfaction with Biktarvy.
Week 24, Week 48 (End of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Catherine B Small, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2020

Primary Completion (Actual)

August 28, 2024

Study Completion (Actual)

August 28, 2024

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

July 25, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-01021384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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