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.