TY - JOUR
T1 - 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: The Kesho Bora Multicentre Collaborative Study rationale, design, and implementation challenges
AU - Farley, Timothy M.M.
AU - Meda, Nicolas
AU - Fao, Paulin
AU - Kyzerbo, Odette
AU - Gouem, Clarisse
AU - Somda, Paulin
AU - Hien, Hervé
AU - Ouedraogo, Patrice Elysée
AU - Kania, Dramane
AU - Sanou, Armande
AU - Kossiwavi, Ida Ayassou
AU - Sanogo, Bintou
AU - Ouedraogo, Moussa
AU - Siribie, Issa
AU - Valéa, Diane
AU - Ouedraogo, Sayouba
AU - Somé, Roseline
AU - Rouet, François
AU - Rollins, Nigel
AU - McFetridge, Lynne
AU - Naidu, Kevi
AU - Luchters, Stanley
AU - Reyners, Marcel
AU - Irungu, Eunice
AU - Katingima, Christine
AU - Mwaura, Mary
AU - Ouattara, Gina
AU - Mandaliya, Kishor
AU - Thiongo, Mary
AU - Wambua, Sammy
AU - Nduati, Ruth
AU - Kose, Judith
AU - Njagi, Ephantus
AU - Mwaura, Peter
AU - Newell, Marie Louise
AU - Mepham, Stephen
AU - Viljoen, Johannes
AU - Bland, Ruth
AU - Bazin, Brigitte
AU - Rekacewicz, Claire
AU - Taylor, Allan
AU - Flowers, Nicole
AU - Thigpen, Michael
AU - Fowler, Mary Glenn
AU - Jamieson, Denise
AU - Read, Jennifer S.
AU - Bork, Kirsten
AU - Cames, Cécile
AU - Cournil, Amandine
AU - Claeys, Patricia
PY - 2011/1/1
Y1 - 2011/1/1
N2 - 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).
AB - 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).
KW - Cohort study
KW - Design
KW - HIV/AIDS
KW - Mother-to-child transmission
KW - Randomized controlled trial
U2 - 10.1016/j.cct.2010.09.008
DO - 10.1016/j.cct.2010.09.008
M3 - Article
SN - 1551-7144
VL - 32
SP - 74
EP - 85
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 1
ER -
