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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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