The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients With Hepatitis C Plus Advanced HIV Infections
HIV Infections, Hepatitis C
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring AIDS-Related Opportunistic Infections, Interferon Alfa-2b, Zalcitabine, Didanosine, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Zidovudine, Hepatitis C
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Treatment or suppression of opportunistic infections with standard drugs. Pneumovax, HIB, tetanus, influenza, and hepatitis B vaccines. Clinically indicated antibiotics. Short courses of steroids (< 21 days) for acute problems not related to hepatitis C. Other regularly prescribed medications such as analgesics, nonsteroidal anti-inflammatory agents, antipyretics, allergy medications, and oral contraceptives. Patients must have: HIV positivity. Documented hepatitis C virus. CD4 count <= 200 cells/mm3. No severe liver disease (Grade C Childs-Pugh classification) or chronic liver disease not caused by hepatitis C. Willingness to be followed for the duration of treatment and follow-up period. Prior Medication: Allowed: Prior AZT, ddI, and ddC. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Hepatitis B (HBsAg positive). Autoimmune hepatitis (FANA titer >= 1:160 and anti-smooth muscle antibody titer >= 1:160). Wilson's disease. alpha-1 antitrypsin deficiency. Hemochromatosis. Malignancy requiring systemic chemotherapy. Concurrent Medication: Excluded: Nonnucleoside analog therapy for HIV. Biologic response modifiers. Systemic cytotoxic chemotherapy. Chronic systemic steroid use. Concurrent Treatment: Excluded: Radiation therapy other than local irradiation to the skin. Prior Medication: Excluded: Prednisone within 12 weeks prior to study entry (if patient has received prior daily doses for 1 month or longer duration). Acute therapy for an infection within 2 weeks prior to study entry.
Sites / Locations
- USC CRS
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
- NY Univ. HIV/AIDS CRS