Conditions: HIV-1 Infection
Keywords: HIV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 881
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

Detailed description:

Arms:
arm 1: FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks. arm 2: EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. arm 3: After the Week 96 visit, 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 elects to discontinue the study, whichever occurs first.

Interventions: intervention 1: FTC/RPV/TAF intervention 2: EFV/FTC/TDF Placebo intervention 3: EFV/FTC/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: 600/200/300 mg FDC tablets administered orally once daily intervention 4: Tablets administered orally once daily

Protocol document: