Study Details
To evaluate immunologic, virologic and genetic correlates of HIV-1 transmission through breast milk to further understand the mechanisms of transmission and antiviral immunity that can prevent vertical transmission and to inform design of future investigations and a larger scale study, if indicated.
This will be a pilot observational cohort study of HIV-1 infected pregnant women and their breastfeeding infants. The planned suite of immunological and virological assays will be performed on all mother-infant pairs in who transmit by breast-feeding (~10) plus 60 randomly selected enrolled mothers and their infants, and these measurements will be compared between them as a case-cohort study.
Two-hundred and fifty HIV-1 infected women and their breastfeeding infants in Blantyre, Malawi.
250
Approximately 30-36 months total, with accrual over a period of approximately 12 months and follow-up of each mother-infant pair for up to 18 months, followed by final data cleaning, analysis and reporting over the next six months.
To describe the frequency and magnitude of HIV-specific T-cell and B-cell immune responses in the breast milk and blood of transmitting and non-transmitting women.
To compare the HIV-specific antibody responses in the breast milk,
maternal sera and infant blood.
To compare viral subpopulations in the breast milk, maternal blood, placenta and infant blood.
To examine associations between maternal/fetal genotypes and transmission.