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.