Status:
COMPLETED
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
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Detailed Description
In patients HIV infected, the success rate do not exceed 20% in genotype 1 or 4 patients. In case of treatment failure , patients are rarely re-treated, and liver fibrosis progresses rapidly. The new ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00901524
Start Date
June 1 2009
End Date
June 1 2012
Last Update
March 29 2013
Active Locations (1)
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1
Hôpital Tenon Service des Maladies Infectieuses
Paris, France, 75970