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

Details

• Alternative Title:
  Contemp Clin Trials
• Personal Author:
  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
• Corporate Authors:
  for the BAN Study Team
• 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.
• Keywords:
  Adult Anti-HIV Agents Antiretorival Prophylaxis Breastfeeding Breast Feeding Female Follow-Up Studies HIV-1 HIV Infections Humans Infant Infant, Newborn Infectious Disease Transmission, Vertical Milk, Human Postnatal HIV Transmission Prognosis Retrospective Studies Young Adult

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• Source:
  Contemp Clin Trials. 33(1):55-59
• Pubmed ID:
  22041453
• Pubmed Central ID:
  PMC3253884
• Document Type:
  Journal Article
• Funding:
  SIP 22-09 U48-DP001944-01/DP/NCCDPHP CDC HHSUnited States/ ; U48DP001944/ACL/ACL HHSUnited States/ ; SIP 26-04 U48-DP000059-01/DP/NCCDPHP CDC HHSUnited States/ ; P30 AI050410-15/AI/NIAID NIH HHSUnited States/ ; P30-AI50410/AI/NIAID NIH HHSUnited States/ ; U48 DP000059/DP/NCCDPHP CDC HHSUnited States/ ; R24 TW00798/TW/FIC NIH HHSUnited States/ ; SIP 13-01 U48-CCU409660-09/PHS HHSUnited States/ ; 2-D43 TW01039-06/TW/FIC NIH HHSUnited States/ ; P30 AI050410/AI/NIAID NIH HHSUnited States/
• Volume:
  33
• Issue:
  1
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:2c553399b8b3cc0d41c18763ea04adcc840b94e94ed411054e4cb03d29df3a46
• Download URL:
  https://stacks.cdc.gov/view/cdc/33292/cdc_33292_DS1.pdf
• File Type:
  [PDF - 297.45 KB ]