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Randomized Controlled Trial
. 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

Charity Chavula  1 , Dustin Long, Enalla Mzembe, Dumbani Kayira, Charles Chasela, Michael G Hudgens, Mina Hosseinipour, Caroline C King, Sascha Ellington, Margret Chigwenembe, Denise J Jamieson, Charles van der Horst
Affiliations
Randomized Controlled Trial

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

Charity Chavula et al. Contemp Clin Trials. 2012 Jan.

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.

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Figure 1
Figure 1
Implications of halting enrollment to the control antiretroviral arm of the BAN Study.
See this image and copyright information in PMC

References

    1. Geneva: Joint United Nations Programme on HIV/AIDS; 2009. AIDS Epidemic Update.
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    1. Chasela CS, Hudgens MG, Jamieson DJ, et al. Maternal or infant antiretroviral drugs to reduce HIV-1 transmission. N. Engl. J. Med. 2010;362:2271–2281. - PMC - PubMed

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