Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients

Inclusion Criteria

• •Age greater than or equal to 18 years.
• •Documentation of HIV-1 infection by any licensed ELISA test and confirmed by a Western Blot.
• •Documentation of Hepatitis C infection by demonstration of a positive test for hepatitis C antibody.
• •HCV RNA level greater than 2000 IU/ml by bDNA.
• •Infected with HCV genotype 1.
• •Histopathologic features consistent with chronic hepatitis C on liver biopsy at the time of enrollment.
• •Patients with CD4 greater than 300 cells/mm(3).
• •Ability to sign informed consent and willingness to comply with the study requirements and clinic policies.
• •Serum creatinine less than 1.5 mg/dL.
• •Serum phosphorus greater than or equal to 2.2 mg/dL (normal range NIH 2.3-4.3 mg/dL).
• •Neutrophil count greater than or equal to 1000 cells/mm(3).
• •Platelets greater than or equal to 75,000/mm(3).
• •Hemoglobin greater than or equal to 8.0 mg/dL.
• •ALT less than 7 times the NIH upper limit of normal.
• •Serum lipase less than 1.5 times the NIH upper limit of normal.
• •Not pregnant or breast-feeding. Pregnancy test must be negative within two weeks prior to dosing with study medications.
• •If capable of pregnancy: use of effective contraception during study: effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap or sponge, or use of hormonal contraception with an anti-HIV regimen that will not alter metabolism of hormonal contraception. This is advised on the basis of using ribavirin, which may have a potential teratogenic effect in pregnant women.
• •Need to have a primary doctor outside OP8 who will be taking care of the patients for their HIV infection and liver disease.
• •Willing to designate a person for durable power of attorney on the NIH form for medical research and medical care purposes at the NIH Clinical Center.
• •Ability to learn how to safely inject medication subcutaneously.