drugset / Trial / NCT00612755

Efficacy and Safety to Extend Treatment 24 Weeks in co-Infected HIV-HCV Genotype 1 and/or 4

NCT00612755

Phase 4 Completed 43 enrolled Hospital Clinico Universitario San Cecilio
RandomizedParallel-groupOpen-labelTreatment

Summary

A study concerning viral kinetic with 10 co-infected HIV-HCV patients on treatment with peginterferon alfa-2a + ribavirin o IFN + ribavirin was reported in Conference on Retroviruses and Opportunistic Infections 2002 by Dr. Torriani shown half-life of HCV virions and the viral clearance was larger than mono-infected patients. The doubt is if this difference in viral kinetic of HIV-HCV co-infected patients versus mono-infected is related with the loss of profited on treatment. In the APRICOT trial patients genotype 2/3 were treated for 48 weeks and the relapse rates was only 2%. The present study want to evaluate is the treatment extent for 24 weeks more in patients genotype 1 and/or 4 will be improve the percentage of patients with viral clearance at the end of the follow-up period, to prevent relapsed in patients with response at the end of treatment. Patients will be randomized to received 180 µg/week of peginterferon alfa-2a + 1000-1200 mg/day of ribavirin during 24 weeks more or control.

Timeline

Start
2005-10
Primary completion
2007-01
Completion
2008-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg