ANRS HC20 Effectiveness of an Optimized Anti HCV PegIFN-alpha2a + Ribavirin on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effectiveness of an optimized anti HCV treatment (360μg per week of PegIFN-alpha2a + 18mg/kg/j of Ribavirin for 6 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Roche Pharma AG
• Treatments: Hepatitis C Antibodies; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Age over 18 years

• Weight 85 kg below the pre-inclusion visit.

• Documented HIV infection (HIV positive)

• HCV infection documented by a positive PCR

• HCV Genotype 1 or 4

• Compensated liver disease (Child-Pugh below/equal to 6)

• Lymphocytes CD4 above 200/mm3

• Patient not answering a treatment for hepatitis C.

• Patient not covered by dual by Peg-IFN + riba for at least three months (wash out)

Exclusion Criteria:

• Co-infection with HBV (HBsAg positive)

• Neutropenia below 1000/mm3

• Thrombocytopenia below 90000/mm3 or thrombocytosis over 500 000/mm3.

• Hemoglobin below 11 g / dL (men and women)

• Arguments radiological (ultrasound, CT or MRI) of hepatocellular carcinoma cell

• Antiretroviral containing didanosine (ddI) and stavudine (d4T) and zidovudine (AZT) and abacavir (ABC).