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)

April 1, 2026 updated by: ANRS, Emerging Infectious Diseases

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75970
        • Hôpital Tenon Service des Maladies Infectieuses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: PegIFN- alpha 2a + RBV
Drug: Peg-interféron alpha 2a + ribavirin
Pilot study, multicenter, open label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
W72 or W96 (depending of the end of treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Analyze rapid virological response (W4) and early (W12).
Time Frame: W4 and W12
W4 and W12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Philippe BONNARD, MD, Hopital Tenon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria

May 12, 2009

First Posted (Estimated)

May 13, 2009

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HC20 ETOC
  • 2008-000859-10 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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