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

Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.

Patients are randomized to receive oral 3TC/AZT, ddI/AZT, or ddI alone for at least 24 months. PER AMENDMENT 4/29/96: NOTE: Randomization to ZDV+ddI arm was terminated in Spring of 1996 based upon the results of ACTG 152. Patients on that arm will continue on blinded study drug and will be followed until the end of the study.

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.