The Safety and Effectiveness of 935U83 in HIV-Infected Patients

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis for patients whose CD4 counts fall below 200 cells/mm3 or who develop PCP during study participation. Allowed: Acute treatment and secondary prophylaxis for tuberculosis, Mycobacterium avium intracellulare, toxoplasmosis, histoplasmosis, cryptococcosis, disseminated candidiasis, or cytomegalovirus infection. Patients must have: HIV infection. CD4 count 200 - 500 cells/mm3. No history of or current AIDS-defining indicator disease by CDC criteria. No antiretroviral therapy within the past 6 months. Consent of parent or guardian if less than 18 years of age. Exclusion Criteria Co-existing Condition: Patient with the following symptoms or conditions are excluded: Current evidence of chronic hepatitis of any etiology. Seropositivity for HBsAg or hepatitis C virus by second generation ELISA. Concurrent Medication: Excluded: Cytotoxic chemotherapy. Other antiretroviral drugs. Immunomodulators. Foscarnet. GM-CSF or G-CSF. Erythropoietin. Concurrent Treatment: Excluded: Radiation therapy. Patients with the following prior conditions are excluded: History of chemical, viral, or alcohol-induced clinical hepatitis within the past 3 years. Prior Medication: Excluded within the past 6 months: Any antiretroviral therapy. HIV immunotherapeutic vaccine. Excluded within the past 4 weeks: Cytotoxic chemotherapy. Immunomodulating agents such as systemic corticosteroids, IL-2, alpha interferon, beta interferon, or gamma interferon. Prior Treatment: Excluded within the past 4 weeks: Radiation therapy. Current alcohol or illicit drug use that may interfere with study compliance.