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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

NCT00901524

CompletedPhase 2

Sponsor: ANRS, Emerging Infectious Diseases

Conditions: Hepatitis

Interventions: Peg-interféron alpha 2a + ribavirin

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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).

Locations (1)

Paris, France