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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001066

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

740

Last updated by the study team

2011-03-02

Who can join

Age: 0 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Stanford Univ School of Medicine — Stanford, California, United States
• Children's Hosp of Denver — Denver, Colorado, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Yale Univ Med School — New Haven, Connecticut, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Howard Univ Hosp — Washington D.C., District of Columbia, United States
• Children's Diagnostic and Treatment Ctr of South Florida — Fort Lauderdale, Florida, United States
• Univ of Florida — Gainesville, Florida, United States
• Univ of Florida Health Science Ctr / Pediatrics — Jacksonville, Florida, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Arnold Palmer Hosp for Children & Women — Orlando, Florida, United States
• All Children's Hosp — St. Petersburg, Florida, United States
• Univ of South Florida — Tampa, Florida, United States
• Saint Joseph's Hosp — Tampa, Florida, United States
• Univ of Alabama at Birmingham Schl of Med / Pediatrics — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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