Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

Inclusion Criteria:

• Previously untreated chronic hepatitis C with HCV-RNA positive in plasma.
• Must have finished the detoxification phase of a drug rehabilitation program and abstained for at least 6 weeks from using abused substance (alcohol, I.V. drugs and inhaled drugs) before starting therapy.
• Liver transaminases (alanine aminotransferase [ALT]) 1.5-fold above the upper limit of normal.
• Controlled HIV infection with a viral load <10,000 copies/mL and a CD4 cell (T-cell) count >200 x 10^6 cells/L, in response to a stable antiretroviral treatment (ART) or without ART if it is not required.
• Compensated liver disease with protocol-specified minimum hematologic, biochemical, and serologic criteria at the Entry visit.
• Alpha-fetoprotein value within normal limits obtained within one year prior to entry. Results above the upper limit of normal but <=50 ng/mL require both of the following: Alpha-fetoprotein value <=50 ng/mL obtained within 3 months prior to entry in the study and Ultrasound obtained within 3 months prior to entry in the study or that is negative for evidence of hepatocellular carcinoma.
• Liver biopsy (optional) within 12 months prior to study entry with a pathology report confirming that the histologic diagnosis is consistent with chronic hepatitis.
• Women of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.
• Reconfirmation that sexually active males must be practicing acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
• Subjects must be free of any clinically significant diseases other than hepatitis or HIV infection that would interfere with study evaluations.

Exclusion Criteria:

• Suspected hypersensitivity to interferon, PEG-interferon, or ribavirin.
• HIV therapy using didanosine (ddI) and stavudine (d4T) in their HIV medications, due to the potentiality of the resulting lactic acidosis.
• Participation in any other clinical trial within 30 days of entry to this protocol.
• Treatment with any investigational drug within 30 days of entry to this protocol.
• Subjects with organ transplants other than cornea and hair transplant.
• Any cause for the liver disease based on subject history and biopsy (where applicable) other than chronic hepatitis C, including but not limited to coinfection with hepatitis B virus (HBV); hemochromatosis (iron deposition >2+ in liver parenchyma); alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; obesity-induced liver disease.
• Hemophilia or any other condition that would prevent the subject from having a liver biopsy, including anticoagulant therapy.
• Hemoglobinopathies (eg, Thalassemia)
• Evidence of advanced liver disease such as history or presence of ascites, bleeding varices, and encephalopathy.
• Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol such as preexisting psychiatric condition, especially severe depression, or a history of severe psychiatric disorder.
• Significant cardiovascular dysfunction within the past 6 months (eg, angina, congestive heart failure, recent myocardial infarction, severe hypertension, or significant arrhythmia). Subjects with electrocardiogram (ECG) showing clinically significant abnormalities.
• Poorly controlled diabetes mellitus.
• Chronic pulmonary disease (eg, chronic obstructive pulmonary disease).
• Immunologically mediated disease.
• Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
• Clinical gout.
• Clinically significant retinal abnormalities.
• Alcohol consumption of >20 gr/day.
• Women who are pregnant or nursing.
• Subjects who have not observed the designated washout periods for any of the prohibited medications.