Neurologic, neurocognitive, and brain growth outcomes in human immunodeficiency virus-infected children receiving different nucleoside antiretroviral regimens. Pediatric AIDS Clinical Trials Group 152 Study Team

To compare the impact of three different nucleoside reverse transcriptase inhibitor regimens, zidovudine (ZDV) monotherapy, didanosine (ddI) monotherapy, and ZDV plus ddI combination therapy, on central nervous system (CNS) outcomes in symptomatic human immunodeficiency virus (HIV)-infected children...

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Veröffentlicht in:Pediatrics (Evanston) 1999-09, Vol.104 (3), p.e32-e32
Hauptverfasser: Raskino, C, Pearson, D A, Baker, C J, Lifschitz, M H, O'Donnell, K, Mintz, M, Nozyce, M, Brouwers, P, McKinney, R E, Jimenez, E, Englund, J A
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container_title Pediatrics (Evanston)
container_volume 104
creator Raskino, C
Pearson, D A
Baker, C J
Lifschitz, M H
O'Donnell, K
Mintz, M
Nozyce, M
Brouwers, P
McKinney, R E
Jimenez, E
Englund, J A
description To compare the impact of three different nucleoside reverse transcriptase inhibitor regimens, zidovudine (ZDV) monotherapy, didanosine (ddI) monotherapy, and ZDV plus ddI combination therapy, on central nervous system (CNS) outcomes in symptomatic human immunodeficiency virus (HIV)-infected children. Serial neurologic examinations, neurocognitive tests, and brain growth assessments (head circumference measurements and head computed tomography or magnetic resonance imaging studies) were performed in 831 infants and children who participated in a randomized double-blind clinical trial of nucleoside reverse transcriptase inhibitors. The Pediatric AIDS Clinical Trials Group study 152 conducted between 1991 and 1995 enrolled antiretroviral therapy-naive children. Subjects were stratified by age (3 to
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Pediatric AIDS Clinical Trials Group 152 Study Team</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><creator>Raskino, C ; Pearson, D A ; Baker, C J ; Lifschitz, M H ; O'Donnell, K ; Mintz, M ; Nozyce, M ; Brouwers, P ; McKinney, R E ; Jimenez, E ; Englund, J A</creator><creatorcontrib>Raskino, C ; Pearson, D A ; Baker, C J ; Lifschitz, M H ; O'Donnell, K ; Mintz, M ; Nozyce, M ; Brouwers, P ; McKinney, R E ; Jimenez, E ; Englund, J A</creatorcontrib><description>To compare the impact of three different nucleoside reverse transcriptase inhibitor regimens, zidovudine (ZDV) monotherapy, didanosine (ddI) monotherapy, and ZDV plus ddI combination therapy, on central nervous system (CNS) outcomes in symptomatic human immunodeficiency virus (HIV)-infected children. Serial neurologic examinations, neurocognitive tests, and brain growth assessments (head circumference measurements and head computed tomography or magnetic resonance imaging studies) were performed in 831 infants and children who participated in a randomized double-blind clinical trial of nucleoside reverse transcriptase inhibitors. The Pediatric AIDS Clinical Trials Group study 152 conducted between 1991 and 1995 enrolled antiretroviral therapy-naive children. Subjects were stratified by age (3 to &lt;30 months of age or 30 months to 18 years of age) and randomized in equal proportions to the three treatment groups. Combination ZDV and ddI therapy was superior to either ZDV or ddI monotherapy for most of the CNS outcomes evaluated. Treatment differences were observed within both age strata. ZDV monotherapy showed a modest statistically significant improvement in cognitive performance compared with ddI monotherapy during the initial 24 weeks, but for subsequent protection against CNS deterioration no clear difference was observed between the two monotherapy arms. Combination therapy with ZDV and ddI was more effective than either of the two monotherapies against CNS manifestations of human immunodeficiency virus disease. 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Pediatric AIDS Clinical Trials Group 152 Study Team</atitle><jtitle>Pediatrics (Evanston)</jtitle><addtitle>Pediatrics</addtitle><date>1999-09</date><risdate>1999</risdate><volume>104</volume><issue>3</issue><spage>e32</spage><epage>e32</epage><pages>e32-e32</pages><issn>0031-4005</issn><eissn>1098-4275</eissn><coden>PEDIAU</coden><abstract>To compare the impact of three different nucleoside reverse transcriptase inhibitor regimens, zidovudine (ZDV) monotherapy, didanosine (ddI) monotherapy, and ZDV plus ddI combination therapy, on central nervous system (CNS) outcomes in symptomatic human immunodeficiency virus (HIV)-infected children. Serial neurologic examinations, neurocognitive tests, and brain growth assessments (head circumference measurements and head computed tomography or magnetic resonance imaging studies) were performed in 831 infants and children who participated in a randomized double-blind clinical trial of nucleoside reverse transcriptase inhibitors. The Pediatric AIDS Clinical Trials Group study 152 conducted between 1991 and 1995 enrolled antiretroviral therapy-naive children. Subjects were stratified by age (3 to &lt;30 months of age or 30 months to 18 years of age) and randomized in equal proportions to the three treatment groups. Combination ZDV and ddI therapy was superior to either ZDV or ddI monotherapy for most of the CNS outcomes evaluated. Treatment differences were observed within both age strata. ZDV monotherapy showed a modest statistically significant improvement in cognitive performance compared with ddI monotherapy during the initial 24 weeks, but for subsequent protection against CNS deterioration no clear difference was observed between the two monotherapy arms. Combination therapy with ZDV and ddI was more effective than either of the two monotherapies against CNS manifestations of human immunodeficiency virus disease. The results of this study did not indicate a long-term beneficial effect for ZDV monotherapy compared with ddI monotherapy.</abstract><cop>United States</cop><pub>American Academy of Pediatrics</pub><pmid>10469815</pmid><doi>10.1542/peds.104.3.e32</doi></addata></record>
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source MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
subjects Adolescent
AIDS/HIV
Analysis of Variance
Anti-HIV Agents - therapeutic use
Brain - growth & development
Central Nervous System Diseases - etiology
Central Nervous System Diseases - prevention & control
Child
Child, Preschool
Cognition - drug effects
Didanosine - therapeutic use
Double-Blind Method
Drug Therapy, Combination
Female
HIV Infections - complications
HIV Infections - drug therapy
Humans
Infant
Intelligence Tests
Male
Motor Skills - drug effects
Pediatrics
Reverse Transcriptase Inhibitors - therapeutic use
Zidovudine - therapeutic use
title Neurologic, neurocognitive, and brain growth outcomes in human immunodeficiency virus-infected children receiving different nucleoside antiretroviral regimens. Pediatric AIDS Clinical Trials Group 152 Study Team
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