A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of June 21, 2025
Completed
Keywords
ClinConnect Summary
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 preliminary studies in children, d4T, another HIV inhibitor, has been well tolerated, although an optimum dose has not been determined.
Patients are randomized to receive either oral AZT or oral d4T. Treatment continues until the last patient enrolled has received 52 weeks of therapy, or until the study is terminated.
Gender
ALL
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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oakland, California, United States
San Diego, California, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
New York, New York, United States
Rochester, New York, United States
Los Angeles, California, United States
San Francisco, California, United States
Washington, District Of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Worcester, Massachusetts, United States
New Brunswick, New Jersey, United States
Bronx, New York, United States
Brooklyn, New York, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Bayamon, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Long Beach, California, United States
Los Angeles, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Washington, District Of Columbia, United States
Jacksonville, Florida, United States
Chicago, Illinois, United States
Detroit, Michigan, United States
Paterson, New Jersey, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Memphis, Tennessee, United States
Seattle, Washington, United States
Farmington, Connecticut, United States
New Haven, Connecticut, United States
Camden, New Jersey, United States
Albany, New York, United States
Dallas, Texas, United States
Patients applied
Trial Officials
Kline M
Study Chair
Van Dyke R
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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