A Randomized Comparative Study of Combined Zidovudine-Lamivudine (3TC) vs. the Better of ddI Monotherapy vs. Zidovudine Plus Ddl in Symptomatic HIV-1 Infected Children
Lamivudine
+ Zidovudine
+ Didanosine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.740 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 Months to 15 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 91 locations
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, United StatesOpen Univ of Alabama at Birmingham Schl of Med / Pediatrics in Google MapsArkansas Children's Hosp
Little Rock, United StatesUCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesLong Beach Memorial (Pediatric)
Long Beach, United States