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
  Purpose

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.


Condition Intervention Phase
Hepatitis
Drug: Peg-interféron alpha 2a + ribavirin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Analyze rapid virological response (W4) and early (W12). [ Time Frame: W4 and W12 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: PegIFN- alpha 2a + RBV Drug: Peg-interféron alpha 2a + ribavirin
Pilot study, multicenter, open label

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901524

Locations
France
Hôpital Tenon Service des Maladies Infectieuses
Paris, France, 75970
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Roche Pharma AG
Investigators
Principal Investigator: Philippe BONNARD, MD Hopital Tenon
  More Information

Additional Information:
No publications provided

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     History of Changes
Other Study ID Numbers: 2008-000859-10, ANRS HC 20
Study First Received: April 28, 2009
Last Updated: March 28, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
HCV Genotype 1, 4
Virological response
Ribavirin
PegPegIFN- alpha 2a
Viral Hepatitis (HCV)

Additional relevant MeSH terms:
Hepatitis
Digestive System Diseases
Liver Diseases
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014