HepatitisPhase 2ETOCNCT00901524
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 study testing Peg-interféron alpha 2a + ribavirin in people with Hepatitis, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis
- What is being tested?
- Peg-interféron alpha 2a + ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to Jun 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Hepatitis
- Being tested
- Peg-interféron alpha 2a + ribavirin
- Keywords
- HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)
- Medical subject headings
- Hepatitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-interféron alpha 2a + ribavirinDrug
Pilot study, multicenter, open label
| Study group | Role | What they receive |
|---|---|---|
| PegIFN- alpha 2a + RBV | No intervention | Not described Receives: Drug: Peg-interféron alpha 2a + ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: W72 or W96 (depending of the end of treatment)
Secondary outcomes (1)
Analyze rapid virological response (W4) and early (W12).
Measured: W4 and W12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Philippe BONNARD, MD, Principal investigator, Hopital Tenon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901524
- Sponsor's protocol ID
- ANRS HC20 ETOC
- Other IDs
- 2008-000859-10, 2008
- Acronym
- ETOC
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2009
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00901524
- Acronym / sponsor ID
- ETOC / ANRS HC20 ETOC
- Conditions
- Hepatitis
- Keywords
- HCV Genotype 1, 4, Virological response, Ribavirin, PegPegIFN- alpha 2a, Viral Hepatitis (HCV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PegIFN- alpha 2a + RBV | No intervention | Drug: Peg-interféron alpha 2a + ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peg-interféron alpha 2a + ribavirinPilot study, multicenter, open label | Drug | PegIFN- alpha 2a + RBV |
Primary outcome
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)
1 secondary outcome
Analyze rapid virological response (W4) and early (W12).
Time frame: W4 and W12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Derived from this study: PubMed 24905490Laird 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.
- French National Agency for Research on AIDS and Viral Hepatitis websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe BONNARD, MD principal investigator
Hopital Tenon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peg-interféron alpha 2a + ribavirin in people with Hepatitis, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.