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
- Conditions
- Chronic hepatitis C
- Registration Number
- EUCTR2004-000907-16-ES
- Lead Sponsor
- Bonaventura Clotet/Ramón Planas/Ricard Solá
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Males and females > 18 years old.
RNA-HCV genotype 1 and/or 4 positive
ALT elevated
Biopsy
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the early virological response in patients with chronic hepatitis C co-infected with HIV treated with induction doses of peginterferon alfa-2a 270 mcg/week plus ribavirin 1600 mg/day for 4 weeks follow for peginterferon alfa-2a 180 mcg/week plus ribavirin 1000-1200 mg/day for 8 weeks versus peginterferon alfa-2a 180 mcg/week plus ribavirin 1000-1200 mg/day for 12 weeks ;Secondary Objective: To compare the diference of RNA-HCV between 12 first weeks between both arms of treatment<br>To compare the safety in both arms.;Primary end point(s): Percentage of patients with undetectable RNA-HCV at 12 weeks
- Secondary Outcome Measures
Name Time Method