A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Inclusion Criteria Concurrent Medication: Recommended: PCP prophylaxis. Allowed: Immunoglobulin. Erythropoietin, G-CSF, and GM-CSF. Corticosteroids. Ethionamide or isoniazid for TB if no alternative is available. Pyridoxine (up to 50 mg/day) as vitamin supplement. Patients must have: Symptomatic HIV infection. No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG). Consent of parent or guardian. NOTE: Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted. Prior Medication: Allowed: Maternal immunomodulator or antiretroviral therapy (including during pregnancy). Antiretroviral therapy prior to 2 months. Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Current grade 3 or worse neuropathy / lower motor neuropathy. Other grade 3 or worse clinical or laboratory toxicities. Known intolerance to either AZT or d4T. Concurrent Medication: Excluded: Chemotherapy for active malignancy. Patients with the following prior conditions are excluded: History of grade 3 or worse neuropathy/lower motor neuropathy. Prior Medication: Excluded: More than 6 weeks of prior antiretroviral or immunomodulator therapy. Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.