| Stopping the control arm in response to the DSMB: mother's choice of HIV prophylaxis during breastfeeding in the BAN Study. | |
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MedLine Citation:
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PMID: 22041453 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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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:
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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:
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Title: Contemporary clinical trials Volume: 33 ISSN: 1559-2030 ISO Abbreviation: Contemp Clin Trials Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2012-01-09 Completed Date: 2012-05-29 Revised Date: 2013-02-20 |
Medline Journal Info:
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Nlm Unique ID: 101242342 Medline TA: Contemp Clin Trials Country: United States |
Other Details:
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Languages: eng Pagination: 55-9 Citation Subset: IM |
Copyright Information:
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Published by Elsevier Inc. |
Affiliation:
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UNC Project, Lilongwe, Malawi. cchavula@unclilongwe.org |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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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:
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0/Anti-HIV Agents |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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