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Antimicrobial Agents and Chemotherapy, December 2001, p. 3585-3590, Vol. 45, No. 12
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.12.3585-3590.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Pharmacokinetics of Stavudine and Didanosine Coadministered with Nelfinavir in Human Immunodeficiency Virus-Exposed Neonates

Chokechai Rongkavilit,1,* Pimolrat Thaithumyanon,2 Theshinee Chuenyam,1 Bharat D. Damle,3 Sompop Limpongsanurak,4 Chantana Boonrod,5 Aeumporn Srigritsanapol,6 Elly A. M. Hassink,1,7 Richard M. W. Hoetelmans,8,dagger David A. Cooper,1,9 Joep M. A. Lange,1,8 Kiat Ruxrungtham,1 and Praphan Phanuphak1

HIV Netherlands-Australia-Thailand Research Collaboration, Thai Red Cross AIDS Research Centre,1 Department of Pediatrics2 and Department of Obstetrics & Gynecology,4 Faculty of Medicine, Chulalongkorn University, Division of Pharmacy, King Chulalongkorn Memorial Hospital,5 and Roche Thailand,6 Bangkok, Thailand; Bristol-Myers Squibb, Princeton, New Jersey3; International Antiviral Therapy Evaluation Center, University of Amsterdam,7 and Department of Pharmacy and Pharmacology, Slotervaart Hospital,8 Amsterdam, The Netherlands; and National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia9

Received 12 April 2001/Returned for modification 20 June 2001/Accepted 27 August 2001

We evaluated the pharmacokinetics of stavudine (d4T) and didanosine (ddI) in neonates. Eight neonates born to human immunodeficiency virus-infected mothers were enrolled to receive 1 mg of d4T per kg of body weight twice daily and 100 mg of ddI per m2 once daily in combination with nelfinavir for 4 weeks after birth. Pharmacokinetic evaluations were performed at 14 and 28 days of age. For d4T, on days 14 and 28, the median areas under the concentration-time curves from 0 to 12 h (AUC0-12s) were 1,866 and 1,603, ng · h/ml, respectively, and the median peak concentrations (Cmaxs) were 463 and 507 ng/ml, respectively. For ddI, on days 14 and 28, the median AUC0-10s were 1,573 and 1,562 h · ng/ml, respectively, and the median Cmaxs were 627 and 687 ng/ml, respectively. Systemic levels of exposure to d4T were comparable to those seen in children, suggesting that the pediatric dose of 1 mg/kg twice daily is appropriate for neonates at 2 to 4 weeks of age. Levels of exposure to ddI were modestly higher than those seen in children. Whether this observation warrants a reduction of the ddI dose in neonates is unclear.

* Corresponding author. Present address: Division of Infectious Diseases, Children's Hospital of Michigan, 3901 Beaubien Blvd., Detroit, MI 48201. Phone: (313) 745-5863. Fax: (313) 993-8846. E-mail: crongkav{at}dmc.org.

dagger Present address: Virco Belgium NV, Mechelen, Belgium.

Antimicrobial Agents and Chemotherapy, December 2001, p. 3585-3590, Vol. 45, No. 12
0066-4804/01/$04.00+0   DOI: 10.1128/AAC.45.12.3585-3590.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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