Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Renal Transplant Rejection; HIV Infections

Treatments: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04530630

20-01021384

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Biktarvy for treatment of HIV
• Has allergies to any of the HIV medications in Biktarvy (bictegravir, emtricitabine, or tenofovir alafenamide)
• Currently taking dofetilide or rifampin
• Is pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Biktarvy

Experimental group

Description:

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

Treatment:

Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet