PEDIATRICS Vol. 104 No. 3 September 1999, p. e32

ELECTRONIC ARTICLE:
Neurologic, Neurocognitive, and Brain Growth Outcomes in Human Immunodeficiency Virus-Infected Children Receiving Different Nucleoside Antiretroviral Regimens

Received Jan 13, 1999; accepted Mar 30, 1999.

Claire Raskino^*, Deborah A. Pearson, Carol J. Baker^§, , Marta H. Lifschitz^§, , Karen O'Donnell^¶, Mark Mintz^#, Molly Nozyce^**, Pim Brouwers^§, Ross E. McKinney^¶, Eleanor Jimenez, Janet A. Englund^§, , and for the Pediatric AIDS Clinical Trials Group 152 Study Team

From the ^* Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts; the  Department of Psychiatry and Behavioral Sciences, University of Texas Medical School, Houston, Texas; Baylor College of Medicine, Departments of ^§ Pediatrics and  Microbiology and Immunology, Houston, Texas; ^¶ Department of Pediatrics, Duke University Medical Center, Durham, North Carolina; ^# Division of Neurology, the Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; the ^** Department of Pediatrics, Bronx Lebanon Hospital Center, Bronx, New York; and the  Department of Pediatrics, San Juan City Hospital, Guaynabo, Puerto Rico.

Objectives.  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.

Methods.  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 <30 months of age or 30 months to 18 years of age) and randomized in equal proportions to the three treatment groups.

Results.  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.

Conclusions.  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.  Key words:  zidovudine, didanosine, central nervous system, human immunodeficiency virus, children, head circumference, computed tomography, magnetic resonance imaging, cognitive, motor function.

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