Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected… (NCT00078403) | Clinical Trial Compass
CompletedPhase 2
Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)
United States, Puerto Rico333 participantsStarted 2004-07
Plain-language summary
Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.
Who can participate
Age range
18 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 for Step 1:
* HIV infected
* Stable antiretroviral therapy for at least 8 weeks prior to study entry OR have not received any antiretroviral therapy for at least 4 weeks prior to entry
* HIV viral load less than 50,000 copies/ml within 6 weeks prior to study entry
* CD4 count greater than 200 cells/mm\^3 within 6 weeks prior to study entry
* Hepatitis C virus (HCV) infected
* Either HCV treatment naive OR previously treated with interferon (IFN), PEG-IFN, IFN and ribavirin, or PEG-IFN and ribavirin for at least 12 weeks and HCV RNA positive following their last course of HCV treatment
* Chronic liver disease consistent with chronic viral hepatitis
* At least stage I fibrosis on a liver biopsy obtained within 104 weeks of study entry
* If at stage VI fibrosis, Child-Pugh-Turcotte (CPT) score of 5 or less and no more than Child-Pugh Class A
* Liver enzyme (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and alkaline phosphatase) levels 10 times or less than upper limit of normal
* Agree to use acceptable methods of contraception
Inclusion Criteria for Step 2:
* Currently enrolled in Step 1 or received 12 weeks of PEG-IFN plus ribavirin outside this study
* Detectable HCV viral load and \<2 log10 decrease from baseline in plasma/serum HCV viral load at Week 12.
* On Step 1 study treatment for no longer than 18 weeks
Inclusion Criteria for Step 3:
* Currently enrolled in Step 1
* Undetectable HCV RNA or a 2-log or greater decrease in …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)
Timeframe: Baseline and at week 72 or premature discontinuation
Trial details
NCT IDNCT00078403
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)