Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 HIV Treatment Experienced
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 439
Healthy volunteers: no

Brief summary:
This study will evaluate the noninferiority of Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a nonnucleoside reverse transcriptase inhibitor (NNRTI) plus Truvada® (FTC/TDF) in maintaining HIV-1 RNA \< 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

Detailed description:

Arms:
arm 1: Participants will switch from their baseline treatment regimen to Stribild for up to 96 weeks, and may continue to receive Stribild in the extension phase. arm 2: Participants will stay on their baseline treatment regimen antiretroviral regimen consisting of an NNRTI plus FTC/TDF for up to 96 weeks, and may switch to Stribild in the extension phase.

Interventions: intervention 1: NNRTI intervention 2: FTC/TDF intervention 3: Stribild
Intervention descriptions: intervention 1: NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine. intervention 2: FTC/TDF (200/300 mg) administered according to prescribing information intervention 3: Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food

Protocol document: