Completed

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

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What is being tested

Lamivudine

+ Zidovudine

+ Didanosine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Urogenital Diseases

+ Genital Diseases

From 3 Months to 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 2, 2011
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: March 2, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

740 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexHIV Infections

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 Maps

Arkansas Children's Hosp

Little Rock, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, United States

Long Beach Memorial (Pediatric)

Long Beach, United States
Completed91 Study Centers