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1 January 2007

Volume 44, Number 1
Clinical Infectious Diseases 2007;44:111–119
© 2006 by the Infectious Diseases Society of America. All rights reserved.
1058-4838/2007/4401-0020$15.00
DOI: 10.1086/508869
HIV/AIDS MAJOR ARTICLE

A Randomized, Double‐Blind, Placebo‐Controlled Trial of Combined Nevirapine and Zidovudine Compared with Nevirapine Alone in the Prevention of Perinatal Transmission of HIV in Zimbabwe

Paul Thistle,1,4

Rachel F. Spitzer,4

Richard H. Glazier,5,6,9,10

Richard Pilon,12

Gordon Arbess,5,11

Andrew Simor,7

Eleanor Boyle,11

Inam Chitsike,2

Tsungai Chipato,3

Maureen Gottesman,5,11 and

Michael Silverman8

1The Salvation Army Howard Hospital, Glendale, and Departments of 2Paediatrics and 3Obstetrics and Gynaecology, University of Zimbabwe, Harare, Zimbabwe; and Departments of 4Obstetrics and Gynaecology, 5Family and Community Medicine, 6Public Health Sciences, and 7Laboratory Medicine and Pathobiology and 8Lakeridge Heath Center, Division of Infectious Diseases, University of Toronto, 9Institute for Clinical Evaluative Sciences, 10Centre for Research on Inner City Health, and 11Department of Family and Community Medicine, St. Michael’s Hospital, Toronto, and 12National HIV and Retrovirology Laboratories, Public Health Agency of Canada, Ottawa, Canada

Background.A single dose of nevirapine (sdNVP) administered to both mother and infant can decrease mother‐to‐child transmission of human immunodeficiency virus (HIV) by 47%, compared with ultra‐short course zidovudine therapy (usZDV). There is limited data about the benefit of usZDV added to sdNVP to prevent mother‐to‐child transmission.

Methods.We performed a double‐blind, randomized, placebo‐controlled trial to determine whether usZDV combined with sdNVP improved neonatal outcome, compared with sdNVP alone. Mothers were randomized to 1 of 2 treatment groups. Mothers in the usZDV/sdNVP group received a loading dose of zidovudine (600 mg administered orally) and continued to receive 300‐mg doses of zidovudine orally every 3 h while in labor, and their infants received zidovudine at a dosage of 2 mg per kg of body weight 4 times per day orally for 72 h. Mothers and infants in the sdNVP group received zidovudine placebo dosed in the same manner. All mothers also received nevirapine at a dosage of 200 mg orally while in labor, and all infants received nevirapine 2 mg per kg of body weight orally within 72 h of delivery.

Results.The study was stopped on the basis of futility, because interim data showed that, at present trends, superiority would not be demonstrated. Results at 6 weeks of age were available for 609 infants. The primary end point of HIV RNA positivity or death occurred in 21.8% of infants in the usZDV/sdNVP arm and 23.6% of the infants in the sdNVP arm.

Conclusion.usZDV, when added to a standard 2‐dose regimen of sdNVP, did not demonstrate a clinically important decrease in the combined end point of mother‐to‐child transmission or infant death. High rates of adverse maternal and infant outcome in both study arms suggest that improved approaches are necessary.

Received 30 March 2006; accepted 31 July 2006; electronically published 22 November 2006.

Reprints or correspondence: Dr. M. Silverman, Lakeridge Health Corporation, 1 Hospital Court, Oshawa, Ontario, Canada ().

Cited by

Andrea L Ciaranello, George R Seage, Kenneth A Freedberg, Milton C Weinstein, Shahin Lockman, Rochelle P Walensky. (2008) Antiretroviral drugs for preventing mother-to-child transmission of HIV in sub-Saharan Africa: balancing efficacy and infant toxicity. AIDS 22:17, 2359-2369
Online publication date: 1-Dec-2008.
CrossRef
Katherine A. Belden, Kathleen E. Squires. (2008) HIV infection in women: Do sex and gender matter?. Current Infectious Disease Reports 10:5, 423-431
Online publication date: 1-Oct-2008.
CrossRef
Liesbeth JM Bollen, Sara J Whitehead, Philip A Mock, Wanna Leelawiwat, Suvanna Asavapiriyanont, Amphan Chalermchockchareonkit, Nirun Vanprapar, Tawee Chotpitayasunondh, Janet M McNicholl, Jordan W Tappero, Nathan Shaffer, Rutt Chuachoowong. (2008) Maternal herpes simplex virus type 2 coinfection increases the risk of perinatal HIV transmission: possibility to further decrease transmission?. AIDS 22:10, 1169-1176
Online publication date: 1-Jul-2008.
CrossRef
Pride Chigwedere, George R. Seage, Tun-Hou Lee, M. Essex. (2008) Efficacy of Antiretroviral Drugs in Reducing Mother-to-Child Transmission of HIV in Africa: A Meta-Analysis of Published Clinical Trials. AIDS Research and Human Retroviruses 24:6, 827-837
Online publication date: 1-Jul-2008.
CrossRef
Michael H Chung, James N Kiarie, Barbra A Richardson, Dara A Lehman, Julie Overbaugh, Francis Njiri, Grace C John-Stewart. (2008) Independent Effects of Nevirapine Prophylaxis and HIV-1 RNA Suppression in Breast Milk on Early Perinatal HIV-1 Transmission. JAIDS Journal of Acquired Immune Deficiency Syndromes 46:4, 472-478
Online publication date: 1-Jan-2008.
CrossRef

  • Presented in part: Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, 16 December 2005 (abstract 1187).

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