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Sponsor: University Hospital, Bordeaux
Conditions: HIV Infections, Hepatitis C, Chronic, Treatment Failure
Interventions: Peginterferon alfa2a, Ribavirin
Countries: France
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.
Sex: ALL
Age: 18 Years to 65 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level * HIV infection (CD4\>250/µL, HIV RNA\<10 000 copies/ml) treated or not with antiretroviral therapy * Signed informed consent Exclusion Criteria: * Chronic hepatitis B * Alcohol consumption\>40g/day * Evidence of decompensated liver disease * Hepatocellular carcinoma * Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease
- Bordeaux, France