@article{fdi:010069955, title = {{S}afety and effectiveness of antiretroviral drugs during pregnancy, delivery and breastfeeding for prevention of mother-to-child transmission of {HIV}-1 : the {K}esho {B}ora {M}ulticentre {C}ollaborative {S}tudy rationale, design, and implementation challenges}, author = {{K}esho {B}ora {S}tudy {G}roup and {B}ecquart, {P}ierre}, editor = {}, language = {{ENG}}, abstract = {o 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 {W}est. {E}ast and {S}outh {A}frica ({T}he {K}esho {B}ora {S}tudy). {T}he 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. {T}he study included long-term {ARV} treatment for women with advanced disease, and short-course {ARV} prophylaxis stopped at delivery for women with early disease. {W}omen 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. {B}etween {J}anuary 2005 and {A}ugust 2008 a total of 1140 women were enrolled. {T}his paper describes the study design, interventions and protocol amendments introduced to adapt to evolving scientific knowledge, international guidelines and availability of {ARV} treatment. {T}he paper highlights the successes and challenges during the conduct of the trial. {T}he {K}esho {B}ora {S}tudy 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. {T}he 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.}, keywords = {{SIDA} ; {TRANSMISSION} ; {PREVENTION} {SANITAIRE} ; {MILIEU} {URBAIN} ; {PROTECTION} {MATERNELLE} {ET} {INFANTILE} ; {BURKINA} {FASO} ; {KENYA} ; {AFRIQUE} {DU} {SUD} ; {BOBO} {DIOULASSO} ; {NAIROBI} ; {DURBAN}}, booktitle = {}, journal = {{C}ontemporary {C}linical {T}rials}, volume = {32}, numero = {1}, pages = {74--85}, ISSN = {1551-7144}, year = {2011}, DOI = {10.1016/j.cct.2010.09.008}, URL = {https://www.documentation.ird.fr/hor/fdi:010069955}, }