The purpose of this study is to determine whether pegylated interferon therapy is effective to treat acute hepatitis C infection in HIV-coinfected individuals.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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.
Practice Hintsche
Berlin, Germany
Practice Bieniek
Berlin, Germany
Practice Dupke/Carganico/Baumgarten
Berlin, Germany
Negative hepatitis C ribonucleic acid (HCV-RNA) in peripheral serum
Time frame: Week 24
Normal liver enzymes
Time frame: Week 24
Negative HCV-RNA
Time frame: Week 12 and 48
Normal liver enzymes
Time frame: Week 12 and 48
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
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Berlin, Germany
Ärzteforum Seestraße
Berlin, Germany
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Berlin, Germany
Medical Department I, University Hospital, Bonn University
Bonn, Germany
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