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Contemp Clin Trials. 2012 Jan;33(1):55-9. doi: 10.1016/j.cct.2011.10.006. Epub 2011 Oct 25.

Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.

Author information

  • 1UNC Project, Lilongwe, Malawi. cchavula@unclilongwe.org

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 21 weeks 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.

Published by Elsevier Inc.

PMID:
22041453
[PubMed - indexed for MEDLINE]
PMCID:
PMC3253884
Free PMC Article
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