A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine
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.
Sites / Locations
- Long Beach Memorial Med. Ctr., Miller Children's Hosp.
- Usc La Nichd Crs
- UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
- Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
- UCSD Maternal, Child, and Adolescent HIV CRS
- UCSF Pediatric AIDS CRS
- Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
- Univ. of Colorado Denver NICHD CRS
- Univ. of Connecticut Health Ctr., Dept. of Ped.
- Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease
- Children's National Med. Ctr., ACTU
- Howard Univ. Washington DC NICHD CRS
- Univ. of Florida Jacksonville NICHD CRS
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
- Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
- Cook County Hosp.
- Univ. of Illinois College of Medicine at Chicago, Dept. of Peds.
- Chicago Children's CRS
- Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
- Tulane/LSU Maternal/Child CRS
- Univ. of Maryland Med. Ctr., Div. of Ped. Immunology & Rheumatology
- HMS - Children's Hosp. Boston, Div. of Infectious Diseases
- BMC, Div. of Ped Infectious Diseases
- Baystate Health, Baystate Med. Ctr.
- WNE Maternal Pediatric Adolescent AIDS CRS
- Children's Hospital of Michigan NICHD CRS
- Cooper Univ. Hosp.
- UMDNJ - Robert Wood Johnson
- St. Joseph's Hosp. & Med. Ctr. of New Jersey
- Children's Hospital at Albany Medical Center, Dept. of Peds.
- Bronx-Lebanon Hosp. IMPAACT CRS
- SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
- North Shore-Long Island Jewish Health System, Dept. of Peds.
- Schneider Children's Hosp., Div. of Infectious Diseases
- NYU Med. Ctr., Dept. of Medicine
- Metropolitan Hosp. NICHD CRS
- Columbia IMPAACT CRS
- Incarnation Children's Ctr.
- Harlem Hosp. Ctr. NY NICHD CRS
- Univ. of Rochester ACTG CRS
- SUNY Stony Brook NICHD CRS
- SUNY Upstate Med. Univ., Dept. of Peds.
- UNC at Chapel Hill School of Medicine - Dept. of Peds., Div. of Immunology & Infectious Diseases
- DUMC Ped. CRS
- The Children's Hosp. of Philadelphia IMPAACT CRS
- St. Christopher's Hosp. for Children
- Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
- St. Jude/UTHSC CRS
- Children's Med. Ctr. Dallas
- Texas Children's Hosp. CRS
- UW School of Medicine - CHRMC
- Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds.
- San Juan City Hosp. PR NICHD CRS
- Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS