CompletedPhase 4

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

United States20 participantsStarted 2020-11-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml

Timeframe: Up to week 48 (End of Study)

Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)

Timeframe: Up to week 48 (End of study)

Intracellular TAF Levels as Measured by Dried Blood Spot

Timeframe: 12 weeks

Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)

Timeframe: 12 weeks

Renal Function as Measured by Blood Urea Nitrogen (BUN)

Timeframe: 24 weeks, 48 weeks (End of study)

Renal Function as Measured by Creatinine

Timeframe: 24 weeks, 48 weeks (End of study)

Renal Function as Measured by Creatinine Clearance

Timeframe: 24 weeks, 48 weeks (End of study)

Trial details

NCT IDNCT04530630

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-28

Results submitted2025-06-27

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Subjects With Plasma HIV-1 Ribonucleic Acid (RNA) <50 Copies/ml

Timeframe: Up to week 48 (End of Study)

Safety (Tolerability) as Measured by the Number of Subjects Who Had a Serious Adverse Event (SAE)

Timeframe: Up to week 48 (End of study)

Intracellular TAF Levels as Measured by Dried Blood Spot

Timeframe: 12 weeks

Intracellular TAF Levels as Measured by Peripheral Blood Mononuclear Cells (PBMCs)

Timeframe: 12 weeks

Renal Function as Measured by Blood Urea Nitrogen (BUN)

Timeframe: 24 weeks, 48 weeks (End of study)

Renal Function as Measured by Creatinine

Timeframe: 24 weeks, 48 weeks (End of study)

Renal Function as Measured by Creatinine Clearance

Timeframe: 24 weeks, 48 weeks (End of study)