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)
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| ClinicalTrials.gov Identifier: NCT00901524 |
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Recruitment Status
:
Completed
First Posted
: May 13, 2009
Last Update Posted
: March 29, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis | Drug: Peg-interféron alpha 2a + ribavirin | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 58 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (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. |
| Study Start Date : | June 2009 |
| Actual Primary Completion Date : | June 2012 |
| Actual Study Completion Date : | June 2012 |
| Arm | Intervention/treatment |
|---|---|
| No Intervention: PegIFN- alpha 2a + RBV |
Drug: Peg-interféron alpha 2a + ribavirin
Pilot study, multicenter, open label
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- 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) ]
- Analyze rapid virological response (W4) and early (W12). [ Time Frame: W4 and W12 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901524
| France | |
| Hôpital Tenon Service des Maladies Infectieuses | |
| Paris, France, 75970 | |
| Principal Investigator: | Philippe BONNARD, MD | Hopital Tenon |
Additional Information:
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 |
| First Posted: | May 13, 2009 Key Record Dates |
| Last Update Posted: | March 29, 2013 |
| Last Verified: | October 2012 |
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
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HCV Genotype 1, 4 Virological response Ribavirin PegPegIFN- alpha 2a Viral Hepatitis (HCV) |
Additional relevant MeSH terms:
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Hepatitis Liver Diseases Digestive System Diseases Interferons Ribavirin Interferon-alpha Peginterferon alfa-2a Hepatitis C Antibodies |
Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |