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Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group.

Publication ,  Journal Article
McKinney, RE; Pizzo, PA; Scott, GB; Parks, WP; Maha, MA; Lehrman, SN; Riggs, M; Eddy, J; Lane, BA; Eppes, SC
Published in: J Pediatr
April 1990

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 less than 0.5 10(9) CD4+ lymphocytes per liter (less than 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 less than 0.75 10(9)/L (750 cells/mm3] occurred in nine patients. The median neutrophil count fell from 2.50 10(9)/L at entry to 1.72 10(9)/L at the end of the study. Anemia requiring transfusion occurred in seven 10(9)/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. No patients required permanent discontinuation of zidovudine because of toxic effects. Positive effects included a faster-than-anticipated rate of weight gain, decreased hepatosplenomegaly, and lowering of the total IgG and IgM concentrations toward more normal values. Zidovudine appears to be safe and to have manageable toxic effects in children.

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Published In

J Pediatr

DOI

ISSN

0022-3476

Publication Date

April 1990

Volume

116

Issue

4

Start / End Page

640 / 647

Location

United States

Related Subject Headings

  • Zidovudine
  • Safety
  • Pediatrics
  • Multicenter Studies as Topic
  • Infusions, Intravenous
  • Infant
  • Humans
  • HIV Infections
  • Follow-Up Studies
  • Drug Tolerance
 

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McKinney, R. E., Pizzo, P. A., Scott, G. B., Parks, W. P., Maha, M. A., Lehrman, S. N., … Eppes, S. C. (1990). Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. J Pediatr, 116(4), 640–647. https://doi.org/10.1016/s0022-3476(05)81619-1
McKinney, R. E., P. A. Pizzo, G. B. Scott, W. P. Parks, M. A. Maha, S. N. Lehrman, M. Riggs, J. Eddy, B. A. Lane, and S. C. Eppes. “Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group.J Pediatr 116, no. 4 (April 1990): 640–47. https://doi.org/10.1016/s0022-3476(05)81619-1.
McKinney, R. E., et al. “Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group.J Pediatr, vol. 116, no. 4, Apr. 1990, pp. 640–47. Pubmed, doi:10.1016/s0022-3476(05)81619-1.
McKinney RE, Pizzo PA, Scott GB, Parks WP, Maha MA, Lehrman SN, Riggs M, Eddy J, Lane BA, Eppes SC. Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. J Pediatr. 1990 Apr;116(4):640–647.
Journal cover image

Published In

J Pediatr

DOI

ISSN

0022-3476

Publication Date

April 1990

Volume

116

Issue

4

Start / End Page

640 / 647

Location

United States

Related Subject Headings

  • Zidovudine
  • Safety
  • Pediatrics
  • Multicenter Studies as Topic
  • Infusions, Intravenous
  • Infant
  • Humans
  • HIV Infections
  • Follow-Up Studies
  • Drug Tolerance