Biktarvy After Kidney Transplant for HIV

Overseen By Elizabeth L Salsgiver, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Weill Medical College of Cornell University

Must not be taking: Dofetilide, Rifampin

Disqualifiers: HIV positive donor, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. 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 Biktarvy. The investigator hypothesizes that Biktarvy 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.

Research Team

Catherine B Small, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for adults over 18 with HIV who have had a kidney transplant and controlled their infection for at least 3 months. It's not for those already on Biktarvy, with allergies to its components, taking certain drugs like dofetilide or rifampin, or if they are pregnant/breastfeeding.

Inclusion Criteria

I have had a kidney transplant.

I am at least 18 years old.

My HIV infection has been under control for at least 3 months.

Exclusion Criteria

I am currently being treated with Biktarvy for HIV.

Received a kidney from a donor who was HIV positive (unless a false positive)

I am currently taking dofetilide or rifampin.

Treatment Details

Interventions

• BIKTARVY 50Mg-200Mg-25Mg Tablet

Trial Overview The study tests switching HIV patients post-kidney transplant to Biktarvy—a single tablet regimen—monitoring its effectiveness and safety over 48 weeks. The goal is to reduce the number of pills these patients take daily.

Participant Groups

Group I: Biktarvy Experimental Treatment 1 Intervention

Participants receive a Biktarvy tablet orally once daily with or without food.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine