Stopping the Control Arm in Response to the DSMB: Mother’s Choice of HIV Prophylaxis during Breastfeeding in the BAN Study

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.; van der Horst, Charles

doi:10.1016/j.cct.2011.10.006

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Stopping the Control Arm in Response to the DSMB: Mother’s Choice of HIV Prophylaxis during Breastfeeding in the BAN Study

Published Date:

Oct 25 2011

Publisher's site:

http://dx.doi.org/10.1016/j.cct.2011.10.006 New Site Icon

Source:

Contemp Clin Trials. 33(1):55-59.

[PDF - 297.45 KB]

Details:

Personal Authors:

Chavula, Charity ; Long, Dustin ; Mzembe, Enalla ; Kayira, Dumbani ; Chasela, Charles ; ... More ▼

Corporate Authors:

for the BAN Study Team

Keywords:

[+]

Pubmed ID:

22041453

Pubmed Central ID:

PMC3253884

Description:

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.

Document Type:

Journal Article

Collection(s):

CDC Public Access

Funding:

2-D43 TW01039-06/TW/FIC NIH HHS/United States
P30 AI050410/AI/NIAID NIH HHS/United States
P30 AI050410-15/AI/NIAID NIH HHS/United States
P30-AI50410/AI/NIAID NIH HHS/United States
R24 TW00798/TW/FIC NIH HHS/United States
SIP 13-01 U48-CCU409660-09/PHS HHS/United States
SIP 22-09 U48-DP001944-01/DP/NCCDPHP CDC HHS/United States
SIP 26-04 U48-DP000059-01/DP/NCCDPHP CDC HHS/United States

Supporting Files:

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nihms334336f1.gif	image/gif
nihms334336f1.jpg	image/jpeg

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