A Phase I Evaluation of the Safety and Toxicity of Zidovudine and Didanosine in Combination in HIV-Infected or Exposed Infants and a Phase II Study of the Effect of Didanosine vs. Combination Therapy With Zidovudine and Didanosine on HIV-1 RNA in Infants With HIV Infection

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: Acetaminophen if not on a continual basis. NOTE: Drugs that are metabolized by hepatic glucuronidation or that are associated with occurrence of pancreatitis are allowed but should be used with caution. Patients must have at least one of the following: Documented HIV infection. Been born to an HIV-infected woman and receiving AZT. PER AMENDMENT 4/8/97: Number 2 above no longer required with closure of Part A of study. Patients must have signed, informed consent of parent or legal guardian. PER 6/20/95 AMENDMENT, patients in Part A must be less than 28 days of age and those in Part B must be less than 90 days of age. PER 7/7/94 AMENDMENT, patients in Part A were less than 120 days of age and those in Part B were less than 180 days of age. NOTE: All patients must have been more than 34 weeks gestation at birth. Prior Medication: Allowed: Prior vaccine therapy. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Pancreatitis. Clinically unstable condition. Current participation on a vaccine trial or, for Part A, a perinatal trial if of indeterminate infection status. Concurrent Medication: Excluded: Vaccine therapy. Patients with the following prior condition are excluded: Pancreatitis at any time since birth. Prior Medication: Excluded in Part B patients only: More than 90 days of prior antiretroviral or immunomodulator therapy, exclusive of therapy received in utero.