drugset / Trial / NCT02125500

Pilot Study to Assess Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-dose Combination in Treatment Experienced Subjects With Hepatitis C Virus (HCV) Genotype 1 - HIV Co-infection

NCT02125500

Phase 2 Completed 68 enrolled ANRS, Emerging Infectious Diseases
NaSingle-groupOpen-labelTreatment

Summary

Aim of the study is to assess the efficacy and safety of 24 weeks of oral Sofosbuvir/Ledipasvir fixed-dose combination (FDC) in subjects with HCV genotype 1 infection and HIV co-infection, who have previously failed a NS3/4A protease inhibitor plus Pegylated interferon /ribavirin regimen or stopped prematurely their treatment for intolerance.

Timeline

Start
2014-08
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ledipasvir Small molecule 90 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral