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.