At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 252 enrolled
Drug / intervention
E/C/F/TAFdrug
Likely dose
E/C/F/TAF 10 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.
A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment
In Brief
A Phase 3 clinical trial evaluating E/C/F/TAF for HIV and HIV Infections. Completed, enrolled 252 participants across 70 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, HIV Infections
CountriesAustralia, Dominican Republic, France, Mexico, Netherlands, Spain, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 2013
Enrollment StartMar 2013
Primary CompletionJul 2014
Study CompletionJul 2018
TodayJul 2026
First PostedMar 26, 2013
Enrollment StartMar 27, 2013
Primary CompletionJul 31, 2014
Study CompletionJul 18, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.3 years ago
Interventions
E/C/F/TAFdrug
E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food