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Trial NCT00000789

Resource URI: http://static.linkedct.org/resource/trials/NCT00000789
PropertyValue
linkedct:brief_title A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
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linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/932>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 6 Years
linkedct:eligibility_minimum_age 3 Months
linkedct:enrollment 230 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000789
rdfs:label Trial NCT00000789
linkedct:lastchanged_date August 25, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00000789
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linkedct:official_title A Randomized, Comparative Trial of Zidovudine (AZT) Versus 2',3'-Didehydro-3'-Deoxythymidine (Stavudine; d4T) in Children With HIV Infection
linkedct:org_study_id ACTG 240
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/33432>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/59934>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000789>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/2390>
linkedct:reference <http://static.linkedct.org/resource/reference/49989>
linkedct:reference <http://static.linkedct.org/resource/reference/53696>
linkedct:reference <http://static.linkedct.org/resource/reference/9170>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date March 1995