CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
STB +6 moredrug
Likely dose
STB 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02246998
NCT02246998Phase 4Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Sep 23, 2014·Updated Jan 3, 2018

In Brief

A Phase 4 clinical trial evaluating STB, TVD, and 5 other interventions for HIV-1 Infection. Completed, enrolled 72 participants across 20 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesBelgium, France, Ireland, Spain, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 23, 2014
Enrollment StartDec 15, 2014
Primary CompletionJan 20, 2016
Study CompletionFeb 17, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.8 years ago

Interventions

STBdrug

150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food

TVDdrug

200/300 mg FDC tablet administered orally once daily with food

ATRdrug

600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime

RTVdrug

100 mg tablet administered orally once daily with food

ATVdrug

300 mg capsule administered orally once daily with food

ABC/3TCdrug

600/300 mg FDC tablet administered orally once daily with food

Iohexoldrug

1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24