A Phase I Study of Combination Therapy With Didanosine (ddI) and Ribavirin in HIV-Infected Children.

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: Acetaminophen for no more than 72 hours. Immunoglobulin. Corticosteroids. Erythropoietin. G-CSF and GM-CSF. Ethionamide or isoniazid for TB if no alternative available. Immunizations according to current recommendations. Patients must have: HIV infection. Immunologic abnormality or clinical symptoms as detailed in the Disease Status field. No active AIDS-defining opportunistic infection or malignancy, no progressive encephalopathy attributable to HIV and no chronic persistent diarrhea. Consent of parent or guardian. PER AMENDMENT 7/2/96: At least 2 of the 5 children in the older half of each cohort must have an ICD p24 antigen concentration >= 70 pg/ml at screening. Prior Medication: Allowed: Up to 6 weeks of prior immunomodulator therapy. Maternal immunomodulator or antiretroviral therapy, including during pregnancy. Prior corticosteroids or intravenous immunoglobulin. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current grade 3 or worse neuropathy/lower motor neuropathy. Clinical or laboratory grade 3 or worse toxicities. Active serious bacterial infection. Concurrent Medication: Excluded: Chemotherapy for active malignancy. Antiretrovirals other than study drugs. Immunomodulators unless specifically allowed. Patients with the following prior condition are excluded: History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: Prior ddI or oral ribavirin. Aerosolized ribavirin within 6 weeks prior to study entry. Antiretroviral or immunomodulator therapy (other than corticosteroids or IVIG) within 1 week prior to blood draws for study entry. Ongoing drug or alcohol abuse.