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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000907-16-ES
Enrollment
Unknown
Registered
2005-11-03
Start date
2005-10-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

Trade Name: Pegasys 180 mcg Pharmaceutical Form: Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 180- Trade Name: Pegasys 135 mcg Pharmaceutical Form: Concentrat

Sponsors

Bonaventura Clotet/Ramón Planas/Ricard Solá
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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 To compare the safety in both arms.;Primary end point(s): Percentage of patients with undetectable RNA-HCV at 12 weeks—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026