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CompletedNCT00901524ETOCUpdated Apr 6, 2026

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

A Phase 2 interventional study of Peg-interféron alpha 2a + ribavirin in Hepatitis, sponsored by ANRS, Emerging Infectious Diseases. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by ANRS, Emerging Infectious Diseases · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Hepatitis

Keywords

  • HCV Genotype 1, 4
  • Virological response
  • Ribavirin
  • PegPegIFN- alpha 2a
  • Viral Hepatitis (HCV)
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In context

Hepatitis

3,380 studies on the registry are indexed under Hepatitis; 202 are open to participants now.

This study's enrollment of 58 is below the median of 100 across 2,388 interventional studies indexed under Hepatitis.

Browse Hepatitis studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 212 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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).
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • No intervention
    PegIFN- alpha 2a + RBV

    Drug: Peg-interféron alpha 2a + ribavirin

Interventions

  • DrugPeg-interféron alpha 2a + ribavirin

    Pilot study, multicenter, open label

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What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Analyze rapid virological response (W4) and early (W12).

    Time frame: W4 and W12

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Study locations

1 site
  • Hôpital Tenon Service des Maladies Infectieuses
    Paris, 75970, France
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References and documents

Publications

  • Laird ME, Mohsen A, Duffy D, Mamdouh R, LeFouler L, Casrouge A, El-Daly M, Rafik M, Abdel-Hamid M, Soulier A, Pawlotsky JM, Hezode 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. PubMed 24905490 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00901524
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Roche Pharma AG
Responsible party
Sponsor
First posted
May 13, 2009
Start date
Jun 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Apr 6, 2026

Study contacts

Philippe BONNARD, MD
principal investigator · Hopital Tenon

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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