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Antimicrobial Agents and Chemotherapy, February 2007, p. 783-786, Vol. 51, No. 2
0066-4804/07/$08.00+0     doi:10.1128/AAC.00420-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics and Safety of Indinavir in Human Immunodeficiency Virus-Infected Pregnant Women{triangledown} ,{dagger}

Jashvant D. Unadkat,1* Diane W. Wara,2 Michael D. Hughes,3 Anita A. Mathias,1 Diane T. Holland,4 Mary E. Paul,5 James Connor,4 Sharon Huang,3 Bach-Yen Nguyen,6 D. Heather Watts,7 Lynne M. Mofenson,7 Elizabeth Smith,8 Paul Deutsch,6 Kathleen A. Kaiser,9 and Ruth E. Tuomala10

Department of Pharmaceutics, University of Washington, Seattle, Washington,1 Department of Pediatrics, University of California San Francisco, San Francisco, California,2 Center for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts,3 Division of Clinical Pharmacology and Developmental Therapeutics, University of California, San Diego, California,4 Baylor College of Medicine, Houston, Texas,5 Merck Research Laboratories, West Point, Pennsylvania,6 Pediatric Adolescent and Maternal AIDS Branch, National Institute of Child Health and Human Development, Bethesda, Maryland,7 Pediatric Medical Branch, Therapeutics Research Plan, Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland,8 Frontier Science and Technology Research Foundation,9 Department of Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts,10

Received 4 April 2006/ Returned for modification 19 May 2006/ Accepted 28 November 2006

Human immunodeficiency virus-infected women (n = 16) received indinavir (800 mg three times a day) plus zidovudine plus lamivudine from 14 to 28 weeks of gestation to 12 weeks postpartum. Two women and eight infants experienced grade 3 or 4 toxicities that were possibly treatment related. Indinavir area under the plasma concentration-time curve was 68% lower antepartum versus postpartum, suggesting increased intestinal and/or hepatic CYP3A activity during pregnancy.

* Corresponding author. Mailing address: Department of Pharmaceutics, University of Washington, Box 357610, Seattle, WA 98195. Phone: (206) 543-9434. Fax: (206) 543-3204. E-mail: jash{at}u.washington.edu.

{triangledown} Published ahead of print on 11 December 2006.

{dagger} This is a PACTG 358 study.

Antimicrobial Agents and Chemotherapy, February 2007, p. 783-786, Vol. 51, No. 2
0066-4804/07/$08.00+0     doi:10.1128/AAC.00420-06
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



This article has been cited by other articles:

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