Status:
COMPLETED
A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Glaxo Wellcome
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
Brief Summary
PRIMARY: To compare the relative safety and tolerance of oral zidovudine (AZT) versus oral stavudine (d4T) in symptomatic HIV-infected children. SECONDARY: To compare the clinical, virologic, and imm...
Detailed Description
At present, AZT is considered the drug of choice for initial treatment of most children with HIV infection, although disease progression or drug intolerance is associated with its long-term use. In pr...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
Recommended:
- PCP prophylaxis.
Allowed:
- Immunoglobulin.
- Erythropoietin, G-CSF, and GM-CSF.
- Corticosteroids.
- Ethionamide or isoniazid for TB if no alternative is available.
- Pyridoxine (up to 50 mg/day) as vitamin supplement.
Patients must have:
- Symptomatic HIV infection.
- No more than 6 weeks of prior antiretroviral or immunomodulator therapy (other than steroids and IVIG).
- Consent of parent or guardian.
NOTE:
- Coenrollment on another ACTG protocol not involving antiretroviral therapy is permitted.
Prior Medication:
Allowed:
- Maternal immunomodulator or antiretroviral therapy (including during pregnancy).
- Antiretroviral therapy prior to 2 months.
- Up to 6 weeks of prior antiretroviral therapy or specific immunomodulator therapy (other than corticosteroids and IVIG).
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Current grade 3 or worse neuropathy / lower motor neuropathy.
- Other grade 3 or worse clinical or laboratory toxicities.
- Known intolerance to either AZT or d4T.
Concurrent Medication:
Excluded:
- Chemotherapy for active malignancy.
Patients with the following prior conditions are excluded:
- History of grade 3 or worse neuropathy/lower motor neuropathy.
Prior Medication:
Excluded:
- More than 6 weeks of prior antiretroviral or immunomodulator therapy.
- Antiretroviral or immunomodulator therapy within 7 days prior to study entry. Ongoing drug or alcohol abuse.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1998
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00000789
End Date
July 1 1998
Last Update
November 4 2021
Active Locations (54)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609