Document Detail


Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study.
MedLine Citation:
PMID:  22041453     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Charity Chavula; 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
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.; Research Support, U.S. Gov't, P.H.S.     Date:  2011-10-25
Journal Detail:
Title:  Contemporary clinical trials     Volume:  33     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2012-01-09     Completed Date:  2012-05-29     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  55-9     Citation Subset:  IM    
Copyright Information:
Published by Elsevier Inc.
Affiliation:
UNC Project, Lilongwe, Malawi. cchavula@unclilongwe.org
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / therapeutic use*
Breast Feeding*
Female
Follow-Up Studies
HIV Infections / prevention & control*,  transmission
HIV-1*
Humans
Infant
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Milk, Human / virology*
Prognosis
Retrospective Studies
Young Adult
Grant Support
ID/Acronym/Agency:
2-D43 TW01039-06/TW/FIC NIH HHS; P30 AI050410-15/AI/NIAID NIH HHS; P30-AI50410/AI/NIAID NIH HHS; R24 TW00798/TW/FIC NIH HHS; SIP 13-01 U48-CCU409660-09//PHS HHS; SIP 22-09 U48-DP001944-01/DP/NCCDPHP CDC HHS; SIP 26-04 U48-DP000059-01/DP/NCCDPHP CDC HHS
Chemical
Reg. No./Substance:
0/Anti-HIV Agents
Comments/Corrections

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