Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients (NCT00221650) | Clinical Trial Compass
CompletedPhase 2
Treatment of Chronic Hepatitis C With PEG Interferon alfa2a and Ribavirin in HIV-infected Patients
France17 participantsStarted 2002-04
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined PEG Interferon alfa-2a and Ribavirin specifically for HIV-positive patients who had already tried and failed HCV treatment — since it's a Phase 2 study that has already completed, what do the results show about sustained virological response rates, and how do those results compare to what I might expect from current standard-of-care options for someone in my situation?
2Because this trial enrolled people who were both HIV-infected and had previously failed HCV treatment, how might my specific HIV status and history of prior HCV treatment affect whether the approach studied here would even be appropriate for my case?
3PEG Interferon and Ribavirin are known to have significant side effects, especially in people living with HIV — given that this was a Phase 2 trial focused on measuring effectiveness, what does my doctor know about the safety profile that emerged, and how would those side effects interact with my current HIV medications?
4Since this trial is completed, are there newer HCV treatments — such as direct-acting antivirals — that have since shown better results for HIV-coinfected patients who have experienced prior treatment failure, and would those be a more appropriate path to consider before looking at an approach like this one?
5The trial measured 'sustained virological response,' meaning undetectable HCV RNA after treatment ends — can my doctor explain what achieving or not achieving that outcome would mean for my long-term liver health, and how likely I am to reach it based on my individual lab values and health history?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with a sustained virological response, defined as an undetectable HCV RNA level
Timeframe: 24 weeks after the end of anti-HCV treatment