Open, multicenter and randomized study phase IV to evaluate the efficacy and safety of 24 weeks more of treatment in patients with chronic hepatitis C genotype 1 and/or 4 co-infected with human inmmunodeficiency virus - Treatment of co-infected HIV/HCV patients genotype 1/4 24 weeks more than standar duratio
- Conditions
- Chronic hepatitis C
- Registration Number
- EUCTR2004-004948-45-ES
- Lead Sponsor
- José Hernández-Quero. Hospital Clínico San Cecilio
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Patients in treatment with peginterferon alfa-2a and ribavirin which HCV-RNA is undetectable at 48 weeks.
- Patients with RNA-HCV positive and genotype 1/4 at 44 weeks before the start of study.
- HIV positive
- AIDS stable
- Pregnancy test negative
- Patient authorization to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients with HCV-RNA positive after 44 weeks of treatment with peginterferon alfa-2a in combination with ribavirin
- Patients with other different treatment to the study.
- 3 o more weeks without treatment between the end of the standard treatment and the inclusion in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method