HCV-HIV Co-Infection Clinical Trial
Official title:
Pilot Study to Assess the 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
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
The clinical trial is multi-center, national, Phase 2, open-label, single-arm.
Primary objective is to estimate the Sustained Virological Response rate (SVR) 12 weeks
after 24 weeks of treatment with quadruple therapy combining Asunaprevir, Daclatasvir,
Ribavirin and Pegylated Interferon alpha-2a in HIV-HCV genotype 1 or 4 coinfected patients
previously null responders to a Pegylated Interferon -Ribavirin standard regimen.
Estimated enrolment is 65 patients during the enrolment period (9 months). The first 12
patients included will be on Raltegravir, Emtricitabine and Tenofovir and will participate
to the pharmacological sub-study.
Schedule of assessments:
Evaluation of inclusion criteria: 4 to 8 weeks Anti-HCV treatment: 28 weeks (or shorter
according to futility rules) Follow up: 24 weeks following the end of the treatment
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic