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Clinical Trials/EUCTR2004-000907-16-ES
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

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.

Registry
who.int
Start Date
November 3, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bonaventura Clotet/Ramón Planas/Ricard Solá

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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