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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 28, 2009

Last Updated Date

March 28, 2013

Start Date ^ICMJE

June 2009

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00901524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hepatitis

Intervention ^ICMJE

Drug: Peg-interféron alpha 2a + ribavirin

Pilot study, multicenter, open label

Study Arm (s)

No Intervention: PegIFN- alpha 2a + RBV

Intervention: Drug: Peg-interféron alpha 2a + ribavirin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00901524

Other Study ID Numbers ^ICMJE

2008-000859-10, ANRS HC 20

Has Data Monitoring Committee

Yes

Responsible Party

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Study Sponsor ^ICMJE

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Collaborators ^ICMJE

Roche Pharma AG

Investigators ^ICMJE

Principal Investigator:

Philippe BONNARD, MD

Hopital Tenon

Information Provided By

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Verification Date

October 2012

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

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