Conditions: HIV-1 HIV Infections Acquired Immunodeficiency Syndrome
Keywords: HIV-1 HIV Treatment-Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral regimens (ARV) in virologically suppressed, HIV-1 positive participants with HIV-1 RNA \<50 copies/mL at Week 24.

This study consists of 48 weeks of open-label phase followed by an optional Extension Phase in which all the participants will receive E/C/F/TAF+DRV.

Detailed description:

Arms:
arm 1: Participants will receive E/C/F/TAF FDC + DRV once daily with food for 48 weeks.

Based on safety and efficacy data from Cohort 1 at Week 4, the participants will be randomized into Cohort 2. The participants in Cohort 1 will continue receiving E/C/F/TAF FDC + DRV through 48 weeks. arm 2: Participants will be randomized to receive E/C/F/TAF FDC+DRV once daily with food for 48 weeks. arm 3: Participants will be randomized to continue on their baseline DRV-containing ARV regimen for 48 weeks.

Interventions: intervention 1: E/C/F/TAF intervention 2: DRV intervention 3: Baseline DRV- containing ARV regimen
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 800 mg tablet administered orally once daily intervention 3: Participants will take their baseline DRV- containing ARV regimen as prescribed.

Protocol document: