Pharmacokinetics and tolerance of zidovudine in preterm infants.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

OBJECTIVE: To determine zidovudine pharmacokinetics and tolerance in premature human human immunodeficiency virus-exposed infants. STUDY DESIGN: Pediatric AIDS Clinical Trials Group Study 331 was a multicentered prospective, open-label study of the use of zidovudine in premature infants. Thirty-eight infants <35 weeks' gestational age (GA) were studied while receiving zidovudine 1.5 mg/kg every 12 hours until 2 weeks of age, then 2.0 mg/kg every 8 hours until 6 weeks of age. Population pharmacokinetics were evaluated at 1, 2, and 4 weeks' postnatal age; zidovudine doses were adjusted to maintain troughs <3 microM. RESULTS: Zidovudine clearance was lower than reported in term infants at similar postnatal ages. Nine premature infants required dose reduction because of high levels (7/19 <30 weeks' and 2/19 >/=30 weeks' GA). Postnatal age, GA, serum creatinine, and furosemide use independently predicted zidovudine clearance. Zidovudine was generally well tolerated in this high-risk population. CONCLUSIONS: Zidovudine clearance is greatly reduced in premature infants. We recommend the following zidovudine dosing schedule in this population: 1.5 mg/kg (intravenous) or 2.0 mg/kg (oral) every 12 hours increased to every 8 hours at 2 weeks of age (>/=30 weeks' GA) or at 4 weeks (<30 weeks' GA).

Full Text

Duke Authors

Cited Authors

  • Capparelli, EV; Mirochnick, M; Dankner, WM; Blanchard, S; Mofenson, L; McSherry, GD; Gay, H; Ciupak, G; Smith, B; Connor, JD; Pediatric AIDS Clinical Trials Group 331 Investigators,

Published Date

  • January 2003

Published In

Volume / Issue

  • 142 / 1

Start / End Page

  • 47 - 52

PubMed ID

  • 12520254

International Standard Serial Number (ISSN)

  • 0022-3476

Digital Object Identifier (DOI)

  • 10.1067/mpd.2003.mpd0335


  • eng

Conference Location

  • United States