Conditions: HIV HIV Infections
Keywords: HIV HIV-1 Infected Treatment Experienced Treatment Naive
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 252
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

Detailed description:

Arms:
arm 1: Participants will receive E/C/F/TAF for 144 weeks. Following Week 144, in countries where E/C/F/TAF is not available (except for the United Kingdom), participants will be given the option to continue in the study and receive E/C/F/TAF for another 48 weeks, or until the product becomes available through an access program, or until Gilead Sciences elects to discontinue the study in that country, whichever comes first.

Interventions: intervention 1: E/C/F/TAF
Intervention descriptions: intervention 1: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food

Protocol document: