A Phase I Safety and Pharmacokinetic Study of 1592U89 Alone and In Combination With Other Antiretroviral Agents in Infants and Children With HIV Infection

Inclusion Criteria Concurrent Medication: Allowed: IVIG. Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor (for management of hematologic toxicity). Patients must have: Documented HIV-1 infection. Laboratory evidence of immunosuppression or symptomatic HIV disease. Parent or legal guardian able and willing to provide signed informed consent. Prior Medication: Required: HIV infected infants and children will be eligible for the trial if they have received greater than 56 days of previous antiretroviral therapy. NOTE: Those children who participated in the single dose phase I study of 1592U89 and satisfy all other criteria for inclusion may have received <= 56 days of previous antiretroviral therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Grade 3 or greater abnormalities in any toxicity monitoring laboratory tests at baseline. Presence of an acute opportunistic infection requiring therapy at the time of enrollment. Intractable or chronic diarrhea or vomiting. Concurrent Medication: Excluded: Chemotherapy for active malignancy. Concurrent use of antiretroviral agents other than those provided by the study, biologic response modifiers, human growth hormone, systemic corticosteroids (>= 14 days duration), probenecid, I.V. pentamidine, immunomodulators (other than intravenous immunoglobulin), or other investigational drugs. Patients with any of the following prior conditions or symptoms are excluded: - History of intolerance to any of the study drugs.