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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Breastfeeding plus infant zidovudine prophylaxis for 6 months vs formula feeding plus infant zidovudine for 1 month to reduce mother-to-child HIV transmission in Botswana - A randomized trial: The Mashi study
JAMA, Volume 296, No. 7, Year 2006
Notification
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Description
Context: Postnatal transmission of human immunodeficiency virus-1 (HIV) via breastfeeding reverses gains achieved by perinatal antiretroviral interventions. Objective: To compare the efficacy and safety of 2 infant feeding strategies for the prevention of postnatal mother-to-child HIV transmission. Design, Setting, and Patients: A 2 X 2 factorial randomized clinical trial with peripartum (single-dose nevirapine vs placebo) and postpartum infant feeding (formula vs breastfeeding with infant zidovudine prophylaxis) interventions. In Botswana between March 27, 2001, and October 29, 2003, 1200 HIV-positive pregnant women were randomized from 4 district hospitals. Infants were evaluated at birth, monthly until age 7 months, at age 9 months, then every third month through age 18 months. Intervention: All of the mothers received zidovudine 300 mg orally twice daily from 34 weeks' gestation and during labor. Mothers and infants were randomized to receive single-dose nevirapine or placebo. Infants were randomized to 6 months of breastfeeding plus prophylactic infant zidovudine (breastfed plus zidovudine), or formula feeding plus 1 month of infant zidovudine (formula fed). Main Outcome Measures: Primary efficacy (HIV infection by age 7 months and HIV-free survival by age 18 months) and safety (occurrence of infant adverse events by 7 months of age) end points were evaluated in 1179 infants. Results: The 7-month HIV infection rates were 5.6% (32 infants in the formula-fed group) vs 9.0% (51 infants in the breastfed plus zidovudine group) (P=.04; 95% confidence interval for difference, -6.4% to -0.4%). Cumulative mortality or HIV infection rates at 18 months were 80 infants (13.9%, formula fed) vs 86 infants (15.1% breastfed plus zidovudine) (P=.60; 95% confidence interval for difference, -5.3% to 2.9%). Cumulative infant mortality at 7 months was significantly higher for the formulafed group than for the breastfed plus zidovudine group (9.3% vs 4.9%; P=.003), but this difference diminished beyond month 7 such that the time-to-mortality distributions through age 18 months were not significantly different (P=.21). Conclusions: Breastfeeding with zidovudine prophylaxis was not as effective as formula feeding in preventing postnatal HIV transmission, but was associated with a lower mortality rate at 7 months. Both strategies had comparable HIV-free survival at 18 months. These results demonstrate the risk of formula feeding to infants in sub-Saharan Africa, and the need for studies of alternative strategies. Trial Registration: clinicaltrials.gov Identifier: NCT00197587 ©2006 American Medical Association. All rights reserved.
Authors & Co-Authors
Thior, Ibou
Unknown Affiliation
Lockman, Shahin
Unknown Affiliation
Smeaton, Laura M.
Unknown Affiliation
Shapiro, Roger L.
Unknown Affiliation
Wester, Carolyn William
Unknown Affiliation
Heymann, Jody S.
Unknown Affiliation
Gilbert, Peter B.
Unknown Affiliation
Stevens, Lisa
Unknown Affiliation
Peter, Trevor F.
Unknown Affiliation
Kim, Soyeon
Unknown Affiliation
van Widenfelt, Erik
Unknown Affiliation
Moffat, Claire
Unknown Affiliation
Ndase, Patrick
Unknown Affiliation
Arimi, Peter
Unknown Affiliation
Kebaabetswe, Poloko M.
Unknown Affiliation
Mazonde, Patson
Unknown Affiliation
Makhema, Joseph M.
Unknown Affiliation
McIntosh, Kenneth
Unknown Affiliation
Novitsky, Vladimir A.
Unknown Affiliation
Lee, Tunhou
Unknown Affiliation
Marlink, Richard G.
Unknown Affiliation
Lagakos, Stephen W.
Unknown Affiliation
Essex, Max E.
Unknown Affiliation
Statistics
Citations: 470
Authors: 23
Affiliations: 8
Identifiers
Doi:
10.1001/jama.296.7.794
ISSN:
00987484
e-ISSN:
15383598
Research Areas
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Botswana
Participants Gender
Female