HIV InfectionsPhase 2ROCO2NCT00221650
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients
A Phase 2 study testing Peginterferon alfa2a and Ribavirin in people with HIV Infections and Hepatitis C, Chronic, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections, Hepatitis C, Chronic, Treatment Failure
- What is being tested?
- Peginterferon alfa2a and Ribavirin
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2002to Jun 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
- HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy
- Signed informed consent
Who cannot join
- Chronic hepatitis B
- Alcohol consumption>40g/day
- Evidence of decompensated liver disease
- Hepatocellular carcinoma
- Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pellegrin, Federation des Maladies Infectieuses, Pr RAGNAUD
Bordeaux, 33076
About this study
Official title: Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.
- Conditions
- HIV Infections, Hepatitis C, Chronic, Treatment Failure
- Being tested
- Peginterferon alfa2a, Ribavirin
- Keywords
- Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use, Ribavirin/adverse effects, Drug Therapy, Combination, Treatment Experienced, Treatment Naive
- Medical subject headings
- HIV Infections, Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa2aDrug
RibavirinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
Measured: 24 weeks after the end of anti-HCV treatment
Secondary outcomes (4)
Proportion of patients with a virological response
Measured: at weeks 24 and 48
Safety of treatment
Influence of anti-HCV treatment on CD4 count and HIV RNA
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2002
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche, Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Didier Neau, MD-PhD, Principal investigator, Hôpital Pellegrin, 33076 Bordeaux Cedex, FranceGenevieve Chene, Pr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221650
- Sponsor's protocol ID
- 9232-01
- Other IDs
- 2000-023
- Acronym
- ROCO2
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38. doi: 10.1186/1471-2288-6-38.
PubMed 16879756Seydi M, Morlat P, Bonnet F, Rambeloarisoa J, Bernard N, Lacoste D, Bonarek M, Trimoulet P, Ramanampamonjy R, Lafon ME, Drame M, Beylot J. [Efficacy and safety of pegylated-interferon plus ribavirin in HIV-infected patients co-infected with hepatitis C virus in clinical practice: a 32 cases observational follow-up]. Rev Med Interne. 2005 Apr;26(4):280-7. doi: 10.1016/j.revmed.2004.11.022. French.
PubMed 15820563
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Peginterferon alfa2a and Ribavirin for the Second Line Treatment of Chronic Hepatitis C in HIV Infected Patients Previously Non Responders to a First Anti-HCV Treatment
- ClinicalTrials.gov ID
- NCT00221650
- Acronym / sponsor ID
- ROCO2 / 9232-01
- Conditions
- HIV Infections, Hepatitis C, Chronic, Treatment Failure
- Keywords
- Hepatitis C, Chronic, HCV infection, HIV infection, Treatment Failure, PEG interferon, Interferons/therapeutic use, Interferon Alfa-2a/adverse effects, Ribavirin/therapeutic use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche, Ministry of Health, France
- Study start
- Apr 2002
- Study completion
- Jun 2004 (actual)
- First posted
- 22 Sep 2005 (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.
Combination of PEG interferon and ribavirin is the standard treatment of chronic hepatitis C. Efficacy of this treatment has never been evaluated in HCV-HIV infected patients, who have previously been treated with a first line anti-HCV treatment. The purpose of the study is to evaluate the combination PEG interferon alfa2a-ribavirin in HIV-infected patients with chronic hepatitis C pretreated with interferon alone or interferon combined with ribavirin. The patients receive a dose of 180 µg of PEGASYS once a week and 800 to 1200 mg/day of ribavirin (according to weight) for 48 weeks. Primary outcome of the study is a sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti-HCV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic hepatitis C : Detectable HCV RNA, Previously treated with interferon or interferon combined with ribavirin, Elevated ALT level
- HIV infection (CD4>250/µL, HIV RNA<10 000 copies/ml) treated or not with antiretroviral therapy
- Signed informed consent
Key exclusion criteria (5 listed)
- Chronic hepatitis B
- Alcohol consumption>40g/day
- Evidence of decompensated liver disease
- Hepatocellular carcinoma
- Other relevant disorders: organ transplantation, psychiatric or cardiovascular disease, poorly controlled diabetes, seizure disorders, hemoglobinopathy, autoimmune disease
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 |
|---|---|---|
| Peginterferon alfa2a | Drug | – |
| Ribavirin | Drug | – |
Primary outcome
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
Time frame: 24 weeks after the end of anti-HCV treatment
4 secondary outcomes
Proportion of patients with a virological response
Time frame: at weeks 24 and 48
Safety of treatment
Influence of anti-HCV treatment on CD4 count and HIV RNA
Proportion of patients with histological response 24 weeks after the end of anti-HCV treatment
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 15 May 2026.
- Background: PubMed 16879756Thiebaut R, Guedj J, Jacqmin-Gadda H, Chene G, Trimoulet P, Neau D, Commenges D. Estimation of dynamical model parameters taking into account undetectable marker values. BMC Med Res Methodol. 2006 Aug 1;6:38. doi: 10.1186/1471-2288-6-38.
- Results publication: PubMed 15820563Seydi M, Morlat P, Bonnet F, Rambeloarisoa J, Bernard N, Lacoste D, Bonarek M, Trimoulet P, Ramanampamonjy R, Lafon ME, Drame M, Beylot J. [Efficacy and safety of pegylated-interferon plus ribavirin in HIV-infected patients co-infected with hepatitis C virus in clinical practice: a 32 cases observational follow-up]. Rev Med Interne. 2005 Apr;26(4):280-7. doi: 10.1016/j.revmed.2004.11.022. French.
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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.
Didier Neau, MD-PhD principal investigator
Hôpital Pellegrin, 33076 Bordeaux Cedex, France
Genevieve Chene, Pr study chair
University Hospital, Bordeaux
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 Peginterferon alfa2a and Ribavirin in people with HIV Infections and Hepatitis C, Chronic, run by University Hospital, Bordeaux 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 3 inclusion and 5 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 15 May 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?
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level (time frame: 24 weeks after the end of anti-HCV 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 NCT00221650, which also lists 2 linked publications.
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 15 May 2026.