NCT00611819

Two Different Treatments 24 vs 48 Weeks Chronic Hepatitis C Genotypes 2 and/or 3 in co-Infected HIV-HCV

Open, Randomized and Multicenter Phase IV Study to Compare the Efficacy and Safety of Two Different Treatments Duration 24 Versus 48 Weeks in Chronic Hepatitis C Genotypes 2 and/or 3 co-Infected HIV-HCV Patients.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The rapidly progression of the disease in HIV-HCV co-infected patients justify the treatment. Combination of Peg interferon and Ribavirin is the best treatment because it improve the compliance of treatment. In APRICOT study genotypes 2 and 3 patients received 48 weeks and the rates of end of treatment response was 64% and the sustained virological response (24 weeks after the end of treatment) 62%. In mono-infected patients trials showed there are not differences in the sustained virological response between 24 and 48 weeks of treatment, however exit the doubt concerning the different kinetic viral in HIV-HCV co-infected patients and this could be related with a lost of profit with a shorter duration of treatment, only 24 weeks. In this study we woud like to evaluate if 24 weeks of treatment in HIV-HCV co-infected patients genotype 2 or 3 will have the same rate of clearance of virus at the end of follow-up period.

Detailed description

Patients will randomized to receive 180 µg/weekly of Pef interferon alpha-2a and 800 mg/daily of Ribavirin during 24 weeks or 48 weeks.

Conditions

• Chronic Hepatitis C
• Co-Infection HIV-HCV

Interventions

Type	Name	Description
DRUG	Peg interferon + Ribavirin	Peg interferon 180 mcg/weekly Ribavirin 800 mg/daily during 24 weeks
DRUG	Peg interferon + Ribavirin	Peg interferon alpha 2a 180 mc/weekly Ribavirin 800 mg/daily during 48 weeks

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-04-01
• Completion: 2008-12-01
• First posted: 2008-02-11
• Last updated: 2008-02-11

Locations

18 sites across 1 country: Spain