Maternal toxicity and pregnancy complications in human immunodeficiency viruseinfected women receiving antiretroviral therapy: PACTG 316 D. Heather Watts, MD, a, * Rajalakshmi Balasubramanian, DSc, b Robert T. Maupin Jr, MD, c Isaac Delke, MD, d Alejandro Dorenbaum, MD, e Simone Fiore, MD, f Marie-Louise Newell, f Jean-Francois Delfraissy, MD, g Richard D. Gelber, PhD, b Lynne M. Mofenson, MD, a Mary Culnane, MS, CRNP, h Coleen K. Cunningham, MD, i for the PACTG 316 Study Team National Institute of Child Health and Human Development, Bethesda, Md, a the Statistical and Data Analysis Center, Harvard School of Public Health, Boston, Mass, b Louisiana State University, New Orleans, La, c the University of Florida, Jacksonville, Fla, d BioMarin Pharmaceutical, Inc, Novato, Calif, e the Institute of Child Health, London, United Kingdom, f Agence Nationale de Rescherches sur le SIDA, APHP, Biatze Hospital, g Centers for Disease Control, h Bangkok, Thailand, and the State University of New York, Upstate Medical University, Syracuse, NY i Received for publication May 20, 2003; revised July 24, 2003; accepted July 29, 2003 – Objective: The purpose of this study was to evaluate rates of maternal toxicity, pregnancy com- plications, and peripartum morbidity by type and duration of antiretroviral therapy (ART) dur- ing pregnancy. Study design: The Pediatric AIDS Clinical Trials Group (PACTG) Protocol 316 (PACTG 316) study evaluated the addition of intrapartum/neonatal nevirapine to background ART to reduce perinatal transmission of human immunodeficiency virus-1 (HIV-1). For this secondary analysis, women were categorized into one of six groups on the basis of ART during pregnancy (monother- apy [monoRx], combination without protease inhibitor [PI], combination with PI), and start time (early: before or during first trimester; late: second or third trimester). Results: One thousand four hundred seven women were included: 288 monoRx late, 34 monoRx early, 327 combo, no PI late, 175 combo, no PI early, 320 combo, PI late, and 263 combo, PI KEY WORDS Human immunodeficiency virus infection Pregnancy Antiretroviral therapy Supported by the Pediatric AIDS Clinical Trials Group of the National Institute of Allergy and Infectious Diseases and the Pediatric/ Perinatal HIV Clinical Trials Network of the National Institute of Child Health and Human Development, National Institutes of Health, the Agence Nationale de Recherches sur le SIDA (ANRS 083) and Boehringer Ingelheim (France); and the European Commission (PL 962005 and QLRT-1999-30002) and the Medical Research Council (UK). This analysis was supported by the Statistical and Data Analysis Center of the AIDS Clinical Trials Group, under the National Institute of Allergy and Infectious Diseases cooperative agreement No. U01 AI41110. Study sites in the United States and other countries with the corresponding investigators are listed in the Appendix. Presented in part as a poster session at the Tenth Conference on Retroviruses and Opportunistic Infections, Boston, Mass, February 2003. *Reprint requests: D. Heather Watts, MD, Pediatric, Adolescent and Maternal AIDS Branch, CRMC/NICHD/NIH, 6100 Executive Blvd, Room 4B11, MSC 7510, Bethesda, MD 20892-7510. E-mail: hw59I@nih.gov www.elsevier.com/locate/ajog American Journal of Obstetrics and Gynecology (2004) 190, 506e16 0002-9378/$ - see front matter Ó 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.ajog.2003.07.018