At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
E/C/F/TAF +1 moredrug
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 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis
In Brief
A Phase 3 clinical trial evaluating E/C/F/TAF and B/F/TAF for HIV-1 Infection. Completed, enrolled 55 participants across 26 sites in 4 countries.
Detailed Summary
The primary objective of this study is to evaluate the safety and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV-1 Infection
CountriesAustria, France, Germany, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 2015
Enrollment StartDec 2015
Primary CompletionSep 2017
Study CompletionOct 2019
TodayJul 2026
First PostedNov 9, 2015
Enrollment StartDec 14, 2015
Primary CompletionSep 29, 2017
Study CompletionOct 15, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 10.6 years ago
Interventions
E/C/F/TAFdrug
150/150/200/10 mg FDC tablets administered orally once daily
B/F/TAFdrug
50/200/25 mg FDC tablets administered orally once daily