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 (ETOC)

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00901524
First received: April 28, 2009
Last updated: March 28, 2013
Last verified: October 2012

April 28, 2009
March 28, 2013
June 2009
June 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: W72 or W96 (depending of the end of treatment) ] [ Designated as safety issue: No ]
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. [ Time Frame: W72 or W96 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00901524 on ClinicalTrials.gov Archive Site
Analyze rapid virological response (W4) and early (W12). [ Time Frame: W4 and W12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis
Drug: Peg-interféron alpha 2a + ribavirin
Pilot study, multicenter, open label
No Intervention: PegIFN- alpha 2a + RBV
Intervention: Drug: Peg-interféron alpha 2a + ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2012
June 2012   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00901524
2008-000859-10, ANRS HC 20
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Roche Pharma AG
Principal Investigator: Philippe BONNARD, MD Hopital Tenon
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP