A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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 immunologic responses between the two treatment groups, and to obtain pharmacokinetic data for both drugs. 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.

Key facts

Study ID

NCT00000789

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

230

Expected to finish

1998-07-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Usc La Nichd Crs — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• UCSF Pediatric AIDS CRS — San Francisco, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Univ. of Connecticut Health Ctr., Dept. of Ped. — Farmington, Connecticut, United States
• Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease — New Haven, Connecticut, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Univ. of Illinois College of Medicine at Chicago, Dept. of Peds. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology — Baltimore, Maryland, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States

Full record on ClinicalTrials.gov

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