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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asunaprevir | Small molecule | 100 mg | — |
| Subject | Daclatasvir | Small molecule | 60 mg | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |
| Subject | Ribavirin | Small molecule | — | — |