Conditions: HIV HIV Infections
Keywords: HIV Treatment Naive HIV 1 Infected Women Female
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) 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

After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. arm 2: E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks

After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded. arm 3: After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates 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: