At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 26 enrolled
Drug / intervention
LDV/SOFdrug
Likely dose
LDV/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.
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects With Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
In Brief
A Phase 2 clinical trial evaluating LDV/SOF for Hepatitis C Infection With HIV Co-Infection. Completed, enrolled 26 participants across 4 sites in 2 countries.
Detailed Summary
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with acute genotype 1 or 4 hepatitis C virus (HCV) and chronic human immunodeficiency virus (HIV)-1 co-infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 2015
Enrollment StartJun 2015
Primary CompletionJan 2016
TodayJul 2026
First PostedMay 29, 2015
Enrollment StartJun 1, 2015
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.1 years ago
Interventions
LDV/SOFdrug
90/400 mg FDC tablet administered orally once daily