At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 107 enrolled
Drug / intervention
SOF/VELdrug
Likely dose
SOF/VEL 100 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 Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Coinfection
In Brief
A Phase 3 clinical trial evaluating SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 107 participants across 15 sites.
Detailed Summary
The primary objectives of this study are to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in participants with chronic HCV infection who were coinfected with HIV-1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 2015
Enrollment StartJul 2015
Primary CompletionApr 2016
Study CompletionJun 2016
TodayJul 2026
First PostedJun 24, 2015
Enrollment StartJul 1, 2015
Primary CompletionApr 29, 2016
Study CompletionJun 22, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 11.0 years ago
Interventions
SOF/VELdrug
400/100 mg fixed-dose combination (FDC) tablet administered orally once daily