Journal article
Safety and effectiveness of antiretroviral drugs during pregnancy, delivery and breastfeeding for prevention of mother-to-child transmission of HIV-1: The Kesho Bora Multicentre Collaborative Study rationale, design, and implementation challenges
Contemporary clinical trials, Vol.32(1), pp.74-85
01/01/2011
DOI: 10.1016/j.cct.2010.09.008
PMID: 20854932
Abstract
To evaluate strategies to reduce HIV-1 transmission through breastfeeding, a multicentre study including a nested randomized controlled trial was implemented in five research sites in West. East and South Africa (The Kesho Bora Study). The aim was to optimize the use of antiretroviral (ARV) drugs during pregnancy, delivery and breastfeeding to prevent mother-to-child transmission of HIV-1 (PMTCT) and to preserve the health of the HIV-1-infected mother. The study included long-term ARV treatment for women with advanced disease, and short-course ARV prophylaxis stopped at delivery for women with early disease. Women with intermediate disease participated in a randomized controlled trial to compare safety and efficacy of triple-ARV prophylaxis prolonged during breastfeeding with short-course ARV prophylaxis stopped at delivery. Between January 2005 and August 2008 a total of 1140 women were enrolled. This paper describes the study design, interventions and protocol amendments introduced to adapt to evolving scientific knowledge, international guidelines and availability of ARV treatment. The paper highlights the successes and challenges during the conduct of the trial. The Kesho Bora Study included one of the few randomized controlled trials to assess safety and efficacy of ARV prophylaxis continued during breastfeeding and the only randomized trial to assess maternal prophylaxis started during pregnancy. The findings have been important for informing international and national guidelines on MTCT prevention in developing countries where, due to poverty, lack of reliable and affordable supply of replacement feed and stigma associated with HIV/AIDS, HIV-infected women have little or no option other than to breastfeed their infants. (ISRCTN71468401). (C) 2010 Elsevier Inc. All rights reserved.
Details
- Title: Subtitle
- Safety and effectiveness of antiretroviral drugs during pregnancy, delivery and breastfeeding for prevention of mother-to-child transmission of HIV-1: The Kesho Bora Multicentre Collaborative Study rationale, design, and implementation challenges
- Creators
- Bobo DioulassoBurkina FasoNicolas MedaPaulin FaoOdette KyzerboClarisse GouemPaulin SomdaHerve HienPatrice Elysee OuedraogoDramane KaniaArmande SanouIda Ayassou KossiwaviBintou SanogoMoussa OuedraogoIssa SiribieDiane ValeaSayouba OuedraogoRoseline SomeKesho Bora Study Group
- Contributors
- Denise Jamieson (Contributor) - University of Iowa, Obstetrics and Gynecology
- Resource Type
- Journal article
- Publication Details
- Contemporary clinical trials, Vol.32(1), pp.74-85
- Publisher
- Elsevier
- DOI
- 10.1016/j.cct.2010.09.008
- PMID
- 20854932
- ISSN
- 1551-7144
- eISSN
- 1559-2030
- Number of pages
- 12
- Grant note
- Centers for Disease Control and Prevention; United States Department of Health & Human Services; Centers for Disease Control & Prevention - USA Development and Research Training in Human Reproduction Department for International Development (DFID) Eunice Kennedy Shriver National Institute of Child Health and Human Development; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD) UNDP/UNFPA/World Bank/WHO Special Programme of Research Belgian Directorate General for International Cooperation Agence Nationale de Recherches sur le SIDA (ANRS); ANRS; Agence Nationale de la Recherche (ANR) Thrasher Research Fund GlaxoSmithKline Foundation; GlaxoSmithKline European and Developing Countries Clinical Trials Partnership (EDCTP)
- Language
- English
- Date published
- 01/01/2011
- Academic Unit
- Obstetrics and Gynecology; VPMA - Administration
- Record Identifier
- 9984446282802771
Metrics
2 Record Views