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: 4

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new HIV treatment option for individuals who have undergone a kidney transplant. The aim is to determine if a daily pill called BIC/F/TAF (known as Biktarvy) effectively and safely manages HIV in this group. Participants will switch from their current HIV medication to BIC/F/TAF and receive monitoring for 48 weeks. Ideal candidates for this trial have controlled HIV, have had a kidney transplant, and are not already taking BIC/F/TAF. As a Phase 4 trial, this research involves an FDA-approved treatment, helping to understand its benefits for more patients.

Will I have to stop taking my current medications?

Yes, you will need to switch from your current HIV medication to the study drug, BIC/F/TAF, for this trial.

What is the safety track record for this treatment?

Research has shown that Biktarvy, a combination of three medicines, is generally safe for people with HIV. Studies have found it safe for individuals with normal kidney function and those with some kidney issues, but it is not recommended for those with severe kidney problems. Early findings suggest that Biktarvy is also safe for adults undergoing dialysis, a treatment for kidney failure. Most people do not experience serious side effects, though some might have mild issues like headaches or nausea. For any concerns, consult your doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Biktarvy for HIV patients who have undergone a kidney transplant because it combines three key components—bictegravir, emtricitabine, and tenofovir alafenamide—into a single tablet. This makes it simpler and more convenient compared to other treatment regimens that may require multiple medications. Biktarvy is also noted for its strong efficacy and improved safety profile, offering a promising option for maintaining viral suppression without compromising kidney function, which is crucial for transplant patients.

What evidence suggests that BIC/F/TAF might be an effective treatment for HIV in post-kidney transplant patients?

Research has shown that Biktarvy, a single pill combining three medications, effectively treats HIV-1, even in individuals with severe kidney disease. In this trial, participants will receive Biktarvy, which studies indicate benefits those with HIV who have undergone a kidney transplant. It poses a lower risk of harming kidney function compared to some older treatments. The single-pill format simplifies adherence to medication schedules. This treatment has effectively managed HIV in patients taking medications to prevent organ rejection after a kidney transplant. ^{1 3 4 6 7}

Who Is on the Research Team?

Catherine B Small, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

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

I am HIV positive.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are switched to Biktarvy and monitored for efficacy, safety, and tolerability

48 weeks

Multiple visits including Day 1, Day 3, Day 5, Day 8, Day 11, Day 22, and every 4 weeks up to Week 48

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 Month Follow Up, 6 Month Follow Up

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/F/TAF) Experimental Treatment 1 Intervention

Participants receive a BIC/F/TAF 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

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39370144/

Bictegravir/emtricitabine/tenofovir alafenamide in adults with ...

These findings support the use of the once-daily B/F/TAF single-tablet regimen for people with HIV-1 and ESKD on HD.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04530630

Study Details | NCT04530630 | Switch to Bictegravir/ ...

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 ...

3.

academic.oup.com

academic.oup.com/ofid/article/9/Supplement_2/ofac492.1090/6903297

1259. Bictegravir or Dolutegravir-Containing Antiretroviral ...

We report the Memorial Transplant Institute's experience using second generation INSTI-containing ART with or without emtricitabine/tenofovir ...

4.

clinicalinfo.hiv.gov

clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/special-populations-transplantation

Special Populations: Transplantation in People with HIV | NIH

Tenofovir alafenamide (TAF) is preferred over tenofovir disoproxil fumarate (TDF) because it has a lower risk of affecting renal function (AII).

5.

askgileadmedical.com

askgileadmedical.com/docs/biktarvy/biktarvy-use-in-renal-transplant-patients

Biktarvy® (BIC/FTC/TAF) Use in Renal Transplant Patients

Bictegravir/emtricitabine/tenofovir alafenamide combination in the management of kidney transplant patients with HIV receiving immunosuppressants. J ...

6.

askgileadmedical.com

askgileadmedical.com/docs/biktarvy/biktarvy-use-in-renal-transplant-patients/pdf

Biktvary® Use in Renal Transplant Patients

Clinical Data ... Bictegravir/emtricitabine/tenofovir alafenamide combination in the management of kidney transplant patients with HIV receiving.

7.

ec.europa.eu

ec.europa.eu/health/documents/community-register/2020/20201028149531/anx_149531_en.pdf

Biktarvy, INN-Bictegravir/Emtricitabine/Tenofovir Alafenamide

In these patients, no differences in the safety profile of Biktarvy were observed. Patients with renal impairment. The safety of emtricitabine + tenofovir ...