Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients


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Thirty-five children with symptomatic human immunodeficiency virus infection were enrolled in a 12-week, three-center phase I study of intravenous and oral zidovudine therapy. At enrollment the children ranged in age from 5 months to 13 years, with a median age of 3 1/2 years. Twenty-one children (60%) had acquired immunodeficiency syndrome and 14 (40%) had the related complex; 20 children had <0.5 109 CD4+ lymphocytes per liter (<500 cells/mm3) at entry. Zidovudine was administered in one of three escalating dose regimens. One or two months of intravenous treatment with zidovudine every 6 hours was followed by orally administered drug on the same schedule; zidovudine was infused at 80, 120, or 160 mg/m2/dose, and the oral dose was one and one-half times the intravenous dosage. Adverse events were similar to those observed in adults. Neutropenia (absolute neutrophil count <0.75 109/L (750 cells/mm3)) occurred in nine patients. The median neutrophil count fell from 2.50 109/L at entry to 1.72 109/L at the end of the study. Anemia requiring transfusion occurred in seven patients; the median hemoglobin level among nontransfused patients decreased from an entry value of 108 to 105 gm/L (10.8 to 10.5 gm/dl). Dosage adjustments were made in 15 patients, in 12 because of anemia or neutropenia. © 1990 The C.V. Mosby Company.

Full Text

Duke Authors

Cited Authors

  • McKinney, RE; Pizzo, PA; Scott, GB; Parks, WP; Maha, MA; Lehrman, SN; Riggs, M; Eddy, J; Lane, BA; Eppes, SC; Wilfert, CM; Pediatric Zidovudine Phase I Study Group,

Published Date

  • January 1, 1990

Published In

Volume / Issue

  • 116 / 4

Start / End Page

  • 640 - 647

International Standard Serial Number (ISSN)

  • 0022-3476

Digital Object Identifier (DOI)

  • 10.1016/S0022-3476(05)81619-1

Citation Source

  • Scopus