Suppressive Long-Term Antiviral Management of Hepatitis C Virus (HCV) and HIV-1 Coinfected Subjects (SLAM-C)

Fecha de inicio: 1 de julio de 2004

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 plasma/serum HCV viral load. * On Step 1 study treatment for no longer than 18 weeks Exclusion Criteria for Steps 1 and 3: * Have received HCV treatment within 4 weeks of study entry. Participants currently receiving treatment for HCV, if non-EVRs, were considered for direct entry into Step 2, without the run-in period in Step 1. * Could not tolerate treatment with PEG-IFN, defined as missing 3 or more consecutive PEG-IFN doses during the first 12 weeks or a total of 5 doses prior to Step 3 entry. Participants who have missed doses of ribavirin will not be excluded from Step 3 entry. * Use of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days prior to study entry * Alpha feto protein level 400 ng/ml or greater within 24 weeks prior to study entry, or alpha feto protein level greater than 50 ng/ml and less than 400 ng/ml (unless computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] shows no evidence of hepatic tumor) within 24 weeks prior to study entry * Decompensated liver disease, including presence or history of ascites, variceal bleeding, and brain or nervous system damage as a result of liver damage * Other causes of significant liver disease, including hepatitis A or B, excess iron deposits in the liver (hemochromatosis), or homozygote alpha-1 antitrypsin deficiency * Use of systemic corticosteroids, interferon gamma, TNF-alpha inhibitors, rifampin, rifabutin, pyrazinamide, isoniazid, ganciclovir, or hydroxyurea within 2 weeks prior to study entry * Known allergy/sensitivity to PEG-IFN alfa-2a or ribavirin or their formulations * History of uncontrolled seizure disorders * Clinically active thyroid disease. Thyroid hormone replacement therapy is permitted, but thyroid-stimulating hormone (TSH) and free thyroxine index (FTI) must be in normal range. * History of autoimmune processes, including Crohn's disease, ulcerative colitis, severe psoriasis, and rheumatoid arthritis, that may be made worse by interferon use * Any systemic antineoplastic or immunomodulatory treatment or radiation within 24 weeks prior to study entry * Malignancy * Active coronary artery disease within 24 weeks prior to study entry * Acute or active AIDS-defining opportunistic infections within 12 weeks of study entry * Hemoglobin abnormalities (e.g., thalassemia) or any other cause of or tendency to break down red blood cells (hemolysis) * History of major organ transplantation with an existing functional graft * Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with study adherence * Uncontrolled or active depression or other psychiatric disorder, such as untreated Grade 3 psychiatric disorder, medically untreatable Grade 3 disorder, or any hospitalization within 52 weeks of study entry that, in the opinion of the investigator, may interfere with study requirements * Other serious illness or chronic medical condition that, in the opinion of the investigator, may have prevented participant's completion of the study * Pregnant or breastfeeding