Conditions: HIV-1 Infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 72
Healthy volunteers: no

Brief summary:
The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

Detailed description:

Arms:
arm 1: Participants will receive STB+iohexol for 24 weeks. arm 2: Participants will receive RTV+ATV+TVD+iohexol for 24 weeks. arm 3: Participants will receive ATR+iohexol for 24 weeks. arm 4: Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.

Interventions: intervention 1: STB intervention 2: TVD intervention 3: ATR intervention 4: RTV intervention 5: ATV intervention 6: ABC/3TC intervention 7: Iohexol
Intervention descriptions: intervention 1: 150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food intervention 2: 200/300 mg FDC tablet administered orally once daily with food intervention 3: 600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime intervention 4: 100 mg tablet administered orally once daily with food intervention 5: 300 mg capsule administered orally once daily with food intervention 6: 600/300 mg FDC tablet administered orally once daily with food intervention 7: 1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24

Protocol document: