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 States333 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 range18 Years
SexALL
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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 …
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)