Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Glaxo Wellcome

Conditions:

HIV Infections

Eligibility:

All Genders

3-15 years

Phase:

PHASE2

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 rec...

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...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

740 Patients enrolled

Trial Details

Trial ID

NCT00001066

Last Update

March 2 2011

Active Locations (91)

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Page 1 of 23 (91 locations)

1

Univ of Alabama at Birmingham Schl of Med / Pediatrics

Birmingham, Alabama, United States, 35294

2

Arkansas Children's Hosp

Little Rock, Arkansas, United States, 72202

3

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States, 920930672

4

Long Beach Memorial (Pediatric)

Long Beach, California, United States, 90801

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