@article{93e6d1b907b445ddb6fcff4f4b03fc13,
title = "Randomized study of the tolerance and efficacy of high- versus low-dose zidovudine in human immunodeficiency virus-infected children with mild to moderate symptoms (AIDS Clinical Trials group 128)",
abstract = "The current dosage of zidovudine for children is 180 mg/m2 every 6 h. To investigate whether a lower dosage was equally effective, human immunodeficiency virus (HIV)-infected children (3 months to 12 years) with mild to moderate symptoms were randomly assigned to receive either high-dose (180 mg/m2/dose) or low-dose (90 mg/m2/dose) zidovudine (double-blind). Treatments were compared with respect to neuropsychologic function, survival, clinical and laboratory evidence of disease progression, and safety and tolerance. Four hundred twenty-six HIV-infected children were enrolled; median time for receipt of study drug was 35 months. Zidovudine in either dose was well tolerated, with no difference in efficacy or tolerance by treatment group using any clinical or laboratory parameter. In children with mild to moderate disease, a reduction of zidovudine to 90 mg/m2/dose will result in substantial cost savings and should be the recommended dose.",
author = "Brady, {Michael T.} and Nuala McGrath and Pim Brouwers and Richard Gelber and Fowler, {Mary Glenn} and Ram Yogev and Nancy Hutton and Bryson, {Yvonne J.} and Mitchell, {Charles D.} and Senih Fikrig and William Borkowsky and Eleanor Jimenez and George McSherry and Arye Rubinstein and Wilfert, {Catherine M.} and Kenneth McIntosh and Elkins, {Mary Maha} and Weintrub, {Peggy S.}",
note = "Funding Information: Received 5 September 1995; revised 16 January 1996. Presented in part: X International Conference on AIDS Yokohama, Japan, August 1994 (abstract 268B). Informed consent was obtained from parents or guardians. Human experimentation guidelines of the US Department of Health and Human Services and those of the investigators' institutions were followed in the conduct of this clinical research. Financial support: Pediatric AIDS Clinical Trials Group (ACTG), National Institutes of Health (AI-25924). Reprints or correspondence: Dr. Michael T. Brady, Section of Infectious Diseases, 700 Children's Dr. ED 582, Columbus, OH 43205. * Other Pediatric ACTG participants are listed after the text. Funding Information: Department ofPediatrics and Preventive Medicine, College ofMedicine, Ohio State University, and HIV Program, Children's Hospital, Columbus, Ohio; Statistical and Data Analysis Center, Pediatric AIDS Clinical Trials Group, and Department ofPediatrics (Biostatistics), Harvard Medical School, Harvard School ofPublic Health, DanaFarber Cancer Institute, and Division ofInfectious Diseases, Children's Hospital, Boston, Massachusetts; Neuropsychology Group, Pediatric Branch, Clinical Oncology Program, National Cancer Institute, and Pediatric Medicine Branch, Division ofAIDS, National Institute of Allergy and Infectious Diseases, Bethesda, and Department of Pediatrics, Johns Hopkins University School ofMedicine, Baltimore, Maryland; Section ofPediatric and Maternal HIV Infection, Children's Memorial Hospital, Chicago, Illinois; Department ofPediatrics, UCLA School ofMedicine, Los Angeles, and Department ofPediatrics, University ofCalifornia, San Francisco; Department ofPediatrics, University ofMiami, Florida; Department ofPediatrics, State University ofNew York Health Science Center at Brooklyn, Department of Pediatrics, New York University Medical Center, New York, Departments ofPediatrics and ofMicrobiology and Immunology, Albert Einstein College ofMedicine, Bronx, New York; Department ofClinical Pediatrics, University ofMedicine and Dentistry ofNew Jersey-New Jersey Medical School, Children's Hospital ofNew Jersey, Newark; Department ofPediatrics, Duke University Medical Center, Durham, and Burroughs Wellcome Co., Research Triangle Park, North Carolina; Department ofPediatrics, San Juan City Hospital, Guaynabo, Puerto Rico",
year = "1996",
doi = "10.1093/infdis/173.5.1097",
language = "English (US)",
volume = "173",
pages = "1097--1106",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "5",
}
