This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase II trial is designed to study whether PEG-IFN administration reduces the rate of liver fibrosis progression in subjects with HCV/HIV coinfection who have failed to achieve HCV RNA reductions >2 logs below baseline after 12 weeks of treatment. The primary objective of the study is to compare the reduction in the rate of histologic fibrosis progression from Step 2 entry to study termination between subjects treated with PEG-IFN and untreated controls in subjects with HIV-1 and hepatitis C virus (HCV) coinfection. Secondary objectives include evaluations of quality of life, impact of long-term PEG-IFN use on HCV, HIV, and metabolic parameters. The study will also investigate the role of noninvasive markers of fibrosis in predicting histologic response, including ALT, AST, bilirubin, albumin, and protein.
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