Pharmacokinetics and tolerance of zidovudine in preterm infants

Edmund V. Capparelli, Mark Mirochnick, Wayne M. Dankner, Suzette Blanchard, Lynne Mofenson, George D. McSherry, Hannah Gay, Gregory Ciupak, Betsy Smith, James D. Connor, Elmer David, Richard Stephens, Tzong Jer Wei, Mary Jo Hoyt, Beth Barlow, Sondra Sadler, Stacee Naylor, Ann Petru, Ross McKinney, Lori FergusonMegan Valentine, Jean Hurwitz, Janet Squires, George Johnson, Moya Clarken, Andrea Kovacs, Steven Pelton, Ann Melvin, Lisa Frenkel, Kathleen Mohan, Mary Jo O'Hara, Nancy Wade, Martha Lepow, Patricia Hughes, Michael Horgan, Louis Levy, F. Moncrief Dobson, Laura Clarke-Steffen, Janice Piatt, Coleen Cunningham, Kathie Contello, Emily Barr, Maureen Famiglietti, John Sleasman, Mobeen Rathmore, Abeer Khayat, Michelle Eagle, Saniyyah Mahmoudi, Eleanor Jimenez, Janet Englund, Pamela Lofton, Christine Elsen, Ronda Oram

Research output: Contribution to journalArticlepeer-review

70 Scopus citations


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 οM. 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' CA). Postnatal age, CA, 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' CA) or at 4 weeks (<30 weeks' GA).

Original languageEnglish (US)
Pages (from-to)47-52
Number of pages6
JournalJournal of Pediatrics
Issue number1
StatePublished - Jan 1 2003

All Science Journal Classification (ASJC) codes

  • Pediatrics, Perinatology, and Child Health


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