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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 2

Conditions: HIV Infections

Treatments: Drug: Zidovudine; Drug: Didanosine; Drug: Lamivudine

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00001066

ACTG 300

Details and patient eligibility

About

To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens.

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.

Full description

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.

Sex: All

Ages: 3 months to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.