CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 335 enrolled
Drug / intervention
LDV/SOF +1 moredrug
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.

Search/NCT02073656
NCT02073656Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection

Gilead Sciences·interventional·Posted Feb 27, 2014·Updated Nov 16, 2018

In Brief

A Phase 3 clinical trial evaluating LDV/SOF and RBV for Hepatitis C Virus and HIV. Completed, enrolled 335 participants across 41 sites in 4 countries.

Detailed Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1. Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus, HIV
CountriesCanada, New Zealand, Puerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 27, 2014
Enrollment StartFeb 1, 2014
Primary CompletionNov 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.3 years ago

Interventions

LDV/SOFdrug

90/400 mg FDC tablet administered orally once daily

RBVdrug

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)