A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children

Inclusion Criteria

Concurrent Medication:

Allowed:

• IVIG.
• Prophylaxis for opportunistic infection.
• EPO.
• G-CSF or GM-CSF.

Patients must have:

• Symptomatic HIV infection.
• Less than 56 days of prior antiretroviral therapy.
• Consent of parent or guardian.

NOTE:

• Co-enrollment on ACTG 219, ACTG 220, and certain ACTG opportunistic infection protocols is permitted.

Prior Medication:

Allowed:

• Up to 56 days of prior antiretroviral therapy.
• Prior immunomodulator therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Malignancy.
• Hypersensitivity to a nucleoside analog.
• Current grade 2 or higher amylase/lipase toxicity or grade 3 or 4 other toxicity.

PER AMENDMENT 4/29/96:

• Active opportunistic infection and/or serious bacterial infection at the time of entry.

Concurrent Medication:

Excluded:

• Any other anti-HIV therapy.
• Megestrol acetate ( Megace ).
• Probenecid.
• IV pentamidine.
• Human growth hormone ( hGH ).
• Systemic corticosteroids for more than 2 weeks.

Prior Medication:

Excluded:

• Investigational drug therapy within 14 days prior to study entry.