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Trial NCT00000750

Resource URI: http://static.linkedct.org/resource/trials/NCT00000750
PropertyValue
linkedct:brief_title A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3124>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Patients must have: - HIV infection. - CD4 count >= 2000 cells/mm3 AND >= 30 percent of total lymphocytes. - No signs or symptoms of HIV infection (other than lymphadenopathy, mild hepatomegaly, hypergammaglobulinemia, or splenomegaly, which is permitted). - Consent of parent or guardian. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Serious acute infection requiring parenteral therapy at time of entry. - One or more serious, proven bacterial infections including any of the following: - septicemia; pneumonia; meningitis; bone or joint infection; or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses) that are caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria. - Clinical neurologic/neuropsychologic deficits, or a head circumference less than the fifth percentile. Concurrent Medication: Excluded: - Any agent with known antiretroviral activity. - Acetaminophen, ibuprofen, or aspirin for more than 72 hours continuously. Prior Medication: Excluded: - More than 7 weeks of prior antiretroviral or immunomodulator therapy post-natally. Recommended: - PCP prophylaxis. - Immunizations according to current recommendations.
linkedct:description AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic. Patients are randomized to receive oral AZT (at age-adjusted doses) or placebo. Patients are evaluated at weeks 2 and 4 and every 4 weeks thereafter; those who reach a study endpoint will have their treatment unblinded to allow the clinician to determine which treatment regimen the patient should then receive. Patients who meet the criteria for changes to open-label AZT will be given the appropriate age-adjusted dose without unblinding the original randomization assignment. Patients who complete or discontinue treatment are followed every 6 months for up to 2 years.
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 9 Months
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 400 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000750
rdfs:label Trial NCT00000750
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
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linkedct:nct_id NCT00000750
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase III Study to Evaluate the Safety, Tolerance, and Efficacy of Early Treatment With Zidovudine (AZT) in Asymptomatic Infants With HIV Infection
linkedct:org_study_id ACTG 182
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15170>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/18809>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000750>
linkedct:phase Phase 3
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary Primary: To determine the efficacy of early treatment with zidovudine (AZT) in HIV-infected asymptomatic infants. To determine the safety and tolerance of AZT in this patient population. Secondary: To compare the virologic and immunologic parameters between the treatment groups. To determine the efficacy of AZT as an early treatment to prevent development of CD4+ cell depletion in HIV-infected asymptomatic infants. AZT is currently indicated for primary treatment in children with HIV-associated signs and symptoms and for those with significant immunodeficiency. This study will attempt to determine whether early treatment with AZT prevents the development of symptoms in HIV-infected infants who are asymptomatic.
rdf:type linkedct:trials
linkedct:verification_date October 1996