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:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00901524
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 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
Peginterferon alfa-2a Ribavirin Anti-Infective Agents Antimetabolites |
Antiviral Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015