Conditions: HIV-1 Infection
Keywords: HIV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 632
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.

Detailed description:

Arms:
arm 1: FTC/RPV/TAF plus FTC/RPV/TDF placebo for at least 96 weeks. arm 2: FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. arm 3: After the Week 96 visit is completed, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF, and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead Sciences elects to discontinue the study, whichever occurs first.

Interventions: intervention 1: FTC/RPV/TAF intervention 2: FTC/RPV/TDF Placebo intervention 3: FTC/RPV/TDF intervention 4: FTC/RPV/TAF Placebo
Intervention descriptions: intervention 1: 200/25/25 mg FDC tablets administered orally once daily intervention 2: Tablets administered orally once daily intervention 3: 200/25/300 mg FDC tablets administered orally once daily intervention 4: Tablets administered orally once daily

Protocol document: