Conditions: HIV HIV Infections
Keywords: Treatment Naive HIV 1 Infected
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 707
Healthy volunteers: no

Brief summary:
To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

Detailed description:

Arms:
arm 1: Stribild plus placebo to match Atripla arm 2: Atripla plus placebo to match Stribild

Interventions: intervention 1: Stribild intervention 2: Atripla intervention 3: Stribild Placebo intervention 4: Atripla Placebo
Intervention descriptions: intervention 1: Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily intervention 2: Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime intervention 3: Placebo to match Stribild STR administered orally once daily intervention 4: Placebo to match Atripla tablet administered orally once daily prior to bedtime

Protocol document: