At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 275 enrolled
Drug / intervention
Sofosbuvir +1 moredrug
Likely dose
Sofosbuvir 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 Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
In Brief
A Phase 3 clinical trial evaluating Sofosbuvir and RBV for Chronic Hepatitis C and Human Immunodeficiency Virus. Completed, enrolled 275 participants across 24 sites in 6 countries.
Detailed Summary
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C, Human Immunodeficiency Virus
CountriesAustralia, France, Germany, Italy, Spain, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2013
First PostedFeb 2013
Primary CompletionApr 2014
Study CompletionJul 2014
TodayJul 2026
First PostedFeb 5, 2013
Enrollment StartJan 1, 2013
Primary CompletionApr 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.4 years ago
Interventions
Sofosbuvirdrug
Sofosbuvir 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)