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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PegIFN- alpha 2a + RBV

Group Type NO_INTERVENTION

Peg-interféron alpha 2a + ribavirin

Intervention Type DRUG

Pilot study, multicenter, open label

Interventions

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Peg-interféron alpha 2a + ribavirin

Pilot study, multicenter, open label

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No