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

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 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.

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

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) ]

Secondary Outcome Measures:

Analyze rapid virological response (W4) and early (W12). [ Time Frame: W4 and W12 ]


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 (Adult, Senior)
Sexes Eligible for Study:	All
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:

French National Agency for Research on AIDS and Viral Hepatitis website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hézode C, Rosa I, Renard P, Mohamed MK, Bonnard P, Izopet J, Mallet V, Pol S, Albert ML, Fontanet A. Apolipoprotein H expression is associated with IL28B genotype and viral clearance in hepatitis C virus infection. J Hepatol. 2014 Oct;61(4):770-6. doi: 10.1016/j.jhep.2014.05.040. Epub 2014 Jun 4.


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

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 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

ClinicalTrials.gov processed this record on September 21, 2017

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