It is well established that infants breast fed by their HIV-infected mothers are at risk of acquiring HIV infection through breast milk. However, in low resource settings where the HIV epidemic now predominates, breast feeding cannot simply be replace by breast milk substitutes since alternatives to breast milk are unavailable, unaffordable and unsafe. With this application we aim to test the safety and efficacy of short duration exclusive breast feeding to minimize risks of HIV transmission without increasing risks of non-HIV infant mortality. We propose a 5-year study of HIV-positive mothers and their children to be conducted in two urban primary health care clinics in Lusaka, Zambia. All HIV-positive women and their infants will be offered the two-dose nevirapine intervention and will be counseled about the risks and benefits of infants feeding options. Women who indicate their decision to breast feed will be eligible for enrollment into the study. A culturally appropriate, affordable and sustainable breast feeding education and support program to encourage exclusive breast feeding will be developed, and all women who elect to breast feed will be encouraged to exclusively breast feed to 4 months. Half of the women will be randomized to a counseling program which will encourage abrupt weaning to full replacement feeding at 4 months, and half will be randomized to a program to encourage continued breast feeding after 4 months with the usual introduction of weaning foods. Children will be followed for two years with regular medical histories, physical exams and clinical sampling. The primary objective of the study, based on the random assignment, is to compare HIV transmission rates and under-2 year mortality rates in children who abruptly wean at four months of age versus children who are weaned according to local practice. The second primary objective, based on observational comparisons, is to compare HIV transmission among infants whose mothers adhere to recommendations to exclusively breast feed with those who do not. Secondary objectives are to describe acute and chronic effects of abrupt weaning on child morbidity. The study proposes to test an inexpensive and potentially sustainable public health intervention to reduce HIV transmission through breast feeding while preserving benefits of breast feeding for other aspects of child health in a very low resource settings.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD039611-04
Application #
6536222
Study Section
Special Emphasis Panel (ZRG1-AARR-6 (01))
Program Officer
Nugent, Robert
Project Start
2000-08-15
Project End
2005-05-31
Budget Start
2002-06-01
Budget End
2003-05-31
Support Year
4
Fiscal Year
2002
Total Cost
$1,277,983
Indirect Cost
Name
Boston University
Department
Miscellaneous
Type
Schools of Public Health
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118
Zupin, Luisa; Polesello, Vania; Segat, Ludovica et al. (2018) DEFB1 polymorphisms and HIV-1 mother-to-child transmission in Zambian population. J Matern Fetal Neonatal Med :1-7
Nakamura, Kyle J; Heath, Laura; Sobrera, Edwin R et al. (2017) Breast milk and in utero transmission of HIV-1 select for envelope variants with unique molecular signatures. Retrovirology 14:6
Lombardi, Francesca; Nakamura, Kyle J; Chen, Thomas et al. (2015) A Conserved Glycan in the C2 Domain of HIV-1 Envelope Acts as a Molecular Switch to Control X4 Utilization by Clonal Variants with Identical V3 Loops. PLoS One 10:e0128116
Kuhn, Louise; Kim, Hae-Young; Hsiao, Lauren et al. (2015) Oligosaccharide composition of breast milk influences survival of uninfected children born to HIV-infected mothers in Lusaka, Zambia. J Nutr 145:66-72
Segat, L; Zupin, L; Kim, H-Y et al. (2014) HLA-G 14?bp deletion/insertion polymorphism and mother-to-child transmission of HIV. Tissue Antigens 83:161-7
Tobin, Nicole H; Aldrovandi, Grace M (2014) Are infants unique in their ability to be ""functionally cured"" of HIV-1? Curr HIV/AIDS Rep 11:1-10
Nakamura, Kyle J; Cerini, Chiara; Sobrera, Edwin R et al. (2013) Coverage of primary mother-to-child HIV transmission isolates by second-generation broadly neutralizing antibodies. AIDS 27:337-46
Chan, Christina S; Kim, Hae-Young; Autran, Chloe et al. (2013) Human milk galectin-3 binding protein and breast-feeding-associated HIV transmission. Pediatr Infect Dis J 32:e473-5
Semrau, Katherine; Kuhn, Louise; Brooks, Daniel R et al. (2013) Dynamics of breast milk HIV-1 RNA with unilateral mastitis or abscess. J Acquir Immune Defic Syndr 62:348-55
Mild, Mattias; Gray, Rebecca R; Kvist, Anders et al. (2013) High intrapatient HIV-1 evolutionary rate is associated with CCR5-to-CXCR4 coreceptor switch. Infect Genet Evol 19:369-77

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