At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
SOF +1 moredrug
Likely dose
SOF 400 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 GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
In Brief
A Phase 3 clinical trial evaluating SOF and RBV for Hepatitis C and Human Immunodeficiency Virus. Completed, enrolled 224 participants across 27 sites in 2 countries.
Detailed Summary
This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Human Immunodeficiency Virus
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2012
First PostedAug 2012
Primary CompletionNov 2013
Study CompletionFeb 2014
TodayJul 2026
First PostedAug 17, 2012
Enrollment StartJul 1, 2012
Primary CompletionNov 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.9 years ago
Interventions
SOFdrug
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBVdrug
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)