Chronic Hepatitis C Clinical Trial
Official title:
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.
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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