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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety