EUCTR2004-000907-16-ES
Active, not recruiting
Not Applicable
Open, multicenter and randomized phase IV trial to evaluate the viral kinetic during 12 first weeks of patients with chronic hepatitis C genotype 1 and 4 coinfected with HIV treated with induction doses of peginterferon alfa 2a (270 mcg/week) and ribavirin (1600 mg/day) with the support of epoetin beta (450 UI/kg/week) - Study of viral kinetic of HCV in HIV patients
Bonaventura Clotet/Ramón Planas/Ricard Solá0 sitesNovember 3, 2005
ConditionsChronic hepatitis C
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic hepatitis C
- Sponsor
- Bonaventura Clotet/Ramón Planas/Ricard Solá
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females \> 18 years old.
- •RNA\-HCV genotype 1 and/or 4 positive
- •ALT elevated
- •HIV positive
- •CD4 \> 200/ mcl
- •HIV disease stable
- •HAART stable during 6 weeks before the study and 8 first weeks after the started of study or no HAART and no starting in 6 weeks after the started of study.
- •Pregnancy test negative in the 24 hours previous.
- •Patient authorisation.
- •Are the trial subjects under 18?
Exclusion Criteria
- •IFN or/and ribavirin therapy previous.
- •Cirrhotic patients
- •d4T and ddI concomitant treatment
- •Experimental treatment \< 6 weeks before the study
- •anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab, HBe Ag.
- •Another liver disease
- •Carcinoma hepatocellular
- •Neutrophils \< 1500 cell/mm3
- •Hemoglobin \< 11g/dl for females and \< 12g/dl for males.
- •Platelets \< 70\.000 cell/mm3
Outcomes
Primary Outcomes
Not specified
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