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

Phase 2

Completed

• Conditions: Hepatitis
• Interventions: Drug: Peg-interféron alpha 2a + ribavirin

• Registration Number: NCT00901524
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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 molecules are not yet available for patients co-infected with HIV, and patients having already undergone a first treatment will likely be among the last to be included in trials evaluating the effectiveness of these treatments.

However, recent studies show that it is possible to propose a new treatment "optimized" to these patients in the hope to obtain better success rate. Provide antiretroviral treatment, use of high doses of Peg-interferon and ribavrine, and supporting patients.

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Study Start: 2009-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2013-03-28
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PegIFN- alpha 2a + RBV	Peg-interféron alpha 2a + ribavirin	-

Primary Outcome Measures

Name	Time	Method
Study the proportion of patients co-infected HIV-HCV, non-responders to treatment for HCV (genotype 1 and 4), with a sustained virological response (6 months after stopping treatment (W72 or W96)) at a re-optimized treatment of hepatitis C.	W72 or W96 (depending of the end of treatment)

Secondary Outcome Measures

Name	Time	Method
Analyze rapid virological response (W4) and early (W12).	W4 and W12

Trial Locations

Locations (1)

Hôpital Tenon Service des Maladies Infectieuses; 🇫🇷 Paris, France