Conditions: HIV HIV Infections
Keywords: HIV Treatment Naive HIV 1 Infected Female Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 872
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) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) FDC in HIV-1 positive, antiretroviral treatment-naive adults.

Detailed description:

Arms:
arm 1: E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks arm 2: E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks arm 3: After study unblinding, participants who complete 144 weeks of the study had the option to receive open-label E/C/F/TAF until commercially available, or until Gilead Sciences terminated the study in that country.

Interventions: intervention 1: E/C/F/TAF intervention 2: E/C/F/TDF intervention 3: E/C/F/TDF Placebo intervention 4: E/C/F/TAF Placebo
Intervention descriptions: intervention 1: 150/150/200/10 mg FDC tablet administered orally once daily intervention 2: 150/150/200/300 mg FDC tablet administered orally once daily intervention 3: Tablet administered orally once daily intervention 4: Tablet administered orally once daily

Protocol document: