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

Ross E. McKinney, Philip A. Pizzo, Gwendolyn B. Scott, Wade P. Parks, Mary A. Maha, Sandra Nusinoff Lehrman, Mike Riggs, Jane Eddy, Barbara A. Lane, Stephen C. Eppes, Catherine M. Wilfert, Zidovudine Phase I Study Group Pediatric Zidovudine Phase I Study Group

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)640-647
Number of pages8
JournalThe Journal of Pediatrics
Volume116
Issue number4
DOIs
StatePublished - Apr 1990

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ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

McKinney, R. E., Pizzo, P. A., Scott, G. B., Parks, W. P., Maha, M. A., Lehrman, S. N., Riggs, M., Eddy, J., Lane, B. A., Eppes, S. C., Wilfert, C. M., & Pediatric Zidovudine Phase I Study Group, Z. P. I. S. G. (1990). Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. The Journal of Pediatrics, 116(4), 640-647. https://doi.org/10.1016/S0022-3476(05)81619-1