Conditions: HIV HIV Infections
Keywords: HIV 1 Infection Treatment Naive
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 708
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 ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Stribild intervention 2: ATV intervention 3: Ritonavir intervention 4: FTC/TDF intervention 5: Stribild Placebo intervention 6: ATV Placebo intervention 7: RTV Placebo intervention 8: FTC/TDF 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: Atazanavir 300 mg capsule administered orally once daily intervention 3: Ritonavir (RTV; /r) 100 mg tablet administered orally once daily intervention 4: FTC/TDF 200/300 mg tablet administered orally once daily intervention 5: Placebo to match Stribild administered orally once daily intervention 6: Placebo to match ATV administered orally once daily intervention 7: Placebo to match RTV administered orally once daily intervention 8: Placebo to match FTC/TDF administered orally once daily

Protocol document: