1. Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study
- Author
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Chavula, Charity, Long, Dustin, Mzembe, Enalla, Kayira, Dumbani, Chasela, Charles, Hudgens, Michael G., Hosseinipour, Mina, King, Caroline C., Ellington, Sascha, Chigwenembe, Margret, Jamieson, Denise J., and van der Horst, Charles
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PREVENTIVE medicine , *ANTIRETROVIRAL agents , *HIV infection transmission , *CLINICAL trials , *MEDICAL research ,BREASTFEEDING complications - Abstract
Abstract: The Data and Safety Monitoring Board (DSMB) for the Breastfeeding, Antiretrovirals, and Nutrition study, a clinical trial aimed to prevent postnatal HIV transmission, recommended halting randomization to the enhanced standard-of-care (control) arm. The 67 mother–infant pairs on the control arm and less than 21weeks postpartum at the time of the DSMB recommendation were read a script informing them of the DSMB decision and offering them the maternal or infant antiretroviral interventions for the remainder of the 28-week breastfeeding period. This paper describes the BAN study response to the DSMB decision and what the women on the control arm chose, when given a choice to start the maternal or infant antiretroviral interventions. [Copyright &y& Elsevier]
- Published
- 2012
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