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

Phase 2

Completed

• Conditions: HIV Infections

• Registration Number: NCT00001066
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 1999-11-02
• Primary Completion: 2001-01
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-01
• Last Update Posted: 2011-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 740

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (91)

Univ of Alabama at Birmingham Schl of Med / Pediatrics; 🇺🇸 Birmingham, Alabama, United States

Arkansas Children's Hosp; 🇺🇸 Little Rock, Arkansas, United States

UCSD Med Ctr / Pediatrics / Clinical Sciences; 🇺🇸 La Jolla, California, United States

Long Beach Memorial (Pediatric); 🇺🇸 Long Beach, California, United States

Children's Hosp of Los Angeles/UCLA Med Ctr; 🇺🇸 Los Angeles, California, United States

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States

UCLA Med Ctr / Pediatric; 🇺🇸 Los Angeles, California, United States

Harbor - UCLA Med Ctr / UCLA School of Medicine; 🇺🇸 Los Angeles, California, United States

Children's Hosp of Oakland; 🇺🇸 Oakland, California, United States

Univ of California / Davis; 🇺🇸 Sacramento, California, United States

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