EUCTR2004-000907-16-ESActive, not recruitingNot 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 sitesStarted: November 3, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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?
- •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)
- •F.1.3.1 Number of subjects for this age range
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
- •stimulating growth factors use before the study
- •Severe psiquiatric diseases
- •Others severe diseases
- •Vital organ transplant
- •Abuse of alcohol and/or drugs.
Investigators
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