Open multicentre, phase IV study to evaluate efficacy and safety of pegylated interferon alpha-2a (40 KD) plus ribavirin for chronic hepatitis C with normal transaminases in human immunodeficiency virus-infected patients

Completed

• Conditions: Human immunodeficiency virus/hepatitis C virus (HIV-HCV) co-infection; Infections and Infestations; Human immunodeficiency virus

• Registration Number: ISRCTN01405766
• Lead Sponsor: Roche Farma S.A. (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

Cases:
1. HIV-infected patients
2. Older than 18 years
3. With chronic hepatitis C (positive serum hepatitis C virus-ribonucleic acid [HCV-RNA] and hepatitis C virus [HCV] antibody)
4. Persistent normal alanine aminotransferase (ALT)

Controls:
1. Adult HIV-infected patients
2. With chronic hepatitis C (positive serum HCV-RNA and HCV antibody)
3. Elevated ALT
4. Matched by sex, age, and HCV genotype

Exclusion Criteria

Cases and controls:
1. Patients with hepatic cirrhosis Child B or C
2. CD4 counts less than 200 cells/mm^3
3. Autoimmune diseases or any contraindication for treatment with interferon or ribavirin

Study & Design

• Study Type: Interventional
• Study Design: Not specified