Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment-Naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 279
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Detailed description:

Arms:
arm 1: E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks arm 2: E/C/F/TDF plus E/C/F/TAF placebo for at least 48 weeks arm 3: Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase.

Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase.

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

Protocol document: