Abstract
A total of 1900 pregnant women in the 1st trimester (633 women living with HIV (WLHIV) initiating Dolutegravir (DTG)-based antiretroviral therapy (ART) in pregnancy, 633 WLHIV continuing DTG use from pre-pregnancy, and 634 women without HIV) and their children will be enrolled and followed for two years. As part of this, mother-infant pairs will be required to attend up to 10 study visits separate from routine clinic visits, these visits include 3 antenatal visits (less than or equal to 14, 24-28 and 32-36 weeks) and 7 postnatal visits (<2 and 6 weeks, 3, 6, 12, 18 and 24 months). measurements in mothers will include demographics and health status, hiv disease and art use, intercurrent medical history including concomitant medication use, hiv viral load testing, art adherence, hiv antibody testing in women without hiv; body composition, caloric intake, dysglycemia and insulin resistance (ir), lipid profiles, anthropometry, resting energy expenditure, hepatic steatosis, specimen collection (whole blood, plasma, serum, placenta and breastmilk), systemic and adipose inflammation, as well as metabolites, lipid subspecies and eicosanoids. measurements in infants will include uterine gestational age and fetal growth, as well as metabolites, lipid subspecies and eicosanoids, body composition, dysglycemia and ir, lipid profiles, anthropometry, feeding, specimen collection (cord blood, whole blood, plasma and serum) and intercurrent medical history including concomitant medication use. additional data on maternal health in pregnancy and birth outcomes will be abstracted from medical records.>
