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

Hepatitis Clinical Trial

— ETOC  

Official title:

ANRS HC20 Pilot Study, Multicenter, Assessing the Effectiveness of an Optimized Anti HCV (360μg/Week Induction of PegIFN-alpha2a + 18mg/kg/j of RBV for 6 Months and Then Depending on the Virological Response to S12, Elongation up S72 to the Dual Anti HCV, With Accompanying Measures) on Sustained Virological Response in Patients With HCV Genotype 1 and 4 Non Responders and Co-infected With HIV.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901524
• Other study ID #: 2008-000859-10
• Secondary ID: ANRS HC 20
• Status: Completed
• Phase: Phase 2
• First received: April 28, 2009
• Last updated: March 28, 2013
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: October 2012
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis

Intervention

Drug:
• Peg-interféron alpha 2a + ribavirin
Pilot study, multicenter, open label

Locations

Country	Name	City	State
France	Hôpital Tenon Service des Maladies Infectieuses	Paris

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Analyze rapid virological response (W4) and early (W12).		W4 and W12	No

External Links

•   French National Agency for Research on AIDS and Viral Hepatitis website