NCT02246998

Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults

A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• HIV-1 Infection

Interventions

Type	Name	Description
DRUG	STB	150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
DRUG	TVD	200/300 mg FDC tablet administered orally once daily with food
DRUG	ATR	600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
DRUG	RTV	100 mg tablet administered orally once daily with food
DRUG	ATV	300 mg capsule administered orally once daily with food
DRUG	ABC/3TC	600/300 mg FDC tablet administered orally once daily with food
DRUG	Iohexol	1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24

Timeline

• Start date: 2014-12-15
• Primary completion: 2016-01-20
• Completion: 2016-02-17
• First posted: 2014-09-23
• Last updated: 2018-01-03
• Results posted: 2018-01-03

Locations

20 sites across 5 countries: Belgium, France, Ireland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study