HIV Infections
Conditions
Keywords
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Stavudine
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 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.
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 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.
Interventions
DRUGStavudine
DRUGZidovudine
Sponsors
Glaxo Wellcome
Bristol-Myers Squibb
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
3 Months to 6 Years
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed