NCT00132210

Pegylated Interferon Therapy for Acute Hepatitis C Infection in HIV-infected Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Bonn · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.

Detailed description

Background:HIV-infected individuals are at higher risk of developing a chronic course of hepatitis C after infection. Moreover, chronic hepatitis C is less well treatable in HIV-Coinfected than in hepatitis C monoinfected patients. There is basic research and clinical data on hepatitis C mono-infection supporting high sustained response rates of hepatitis C when treatment is started in the acute phase of infection. Aim of the study: To determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals. Methods: Prospective, open-label, historical controlled trial. Eligible subjects are treated over 24 weeks with a pegylated interferon at standard dose. Weight-adjusted ribavirin comedication is recommended for HCV-genotypes 1 and 4. Treatment will be withheld for 12 weeks in order to allow spontaneous resolution in subjects with clinical symptomatic hepatitis C infection.

Conditions

• Hepatitis C
• HIV Infections

Interventions

Type	Name	Description
DRUG	pegylated interferon	Pegylated interferon alfa-2a or -2b in standard dosage Ribavirin in case of genotype 1 or 4 at 1000 or 1200 mg/d according to body weight ist recommended.

Timeline

• Start date: 2002-09-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-08-19
• Last updated: 2010-10-21

Locations

14 sites across 1 country: Germany