Conditions: Acquired Immunodeficiency Syndrome HIV Infections
Keywords: HIV-1 Treatment Naive Treatment Experienced
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

Brief summary:
This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.

Detailed description:

Arms:
arm 1: Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks.

Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country. arm 2: Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks.

Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country.

Interventions: intervention 1: E/C/F/TDF intervention 2: COBI intervention 3: ATV intervention 4: DRV intervention 5: NRTI
Intervention descriptions: intervention 1: E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily intervention 2: COBI 150 mg tablet administered with food orally once daily intervention 3: ATV 300 mg tablet administered orally once daily intervention 4: DRV 800 mg tablet administered orally once daily intervention 5: Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.

Protocol document: