drugset / Trial / NCT01725542

Pilot Study to Assess the Efficacy of and Tolerance to a QUadruple Therapy to Treat HIV-HCV Coinfected Patients Previously Null Responders

NCT01725542

NaSingle-groupOpen-labelDiagnostic

Summary

Evaluation of efficacy and tolerance to a QUadruple therapy with Asunaprevir , Daclatasvir, Ribavirin and pegylated Interferon alpha-2a, in HIV-HCV genotype 1 or 4 coinfected patients previously null responders to a standard Pegylated Interferon -Ribavirin regimen. The proportion of patients presenting cirrhosis (defined by a METAVIR F4 score on liver biopsy and/or with hepatic impulse elastometry ≥ 15 kPa) will be limited to 50% of all of the patients included

Timeline

Start
2012-12
Primary completion
2014-04
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Asunaprevir Small molecule 100 mg
Subject Daclatasvir Small molecule 60 mg
Subject Peginterferon alfa-2a Protein / enzyme biologic
Subject Ribavirin Small molecule