Pharmacokinetic and Safety of Antiretroviral and Related Drugs in Lactating Women and Breastmilk Fed Infants

Summary

Participation Requirements

Description

Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ?18 years of age receiving DOIs per SOC, as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ?180 days postpartum. To understand drug transfer into breastmilk and de...

Prospective, single-site, open label, PK and safety study. Co-enrollment of lactating women ?18 years of age receiving DOIs per SOC, as prescribed by their healthcare providers, and their infants who receive maternal breastmilk ?180 days postpartum. To understand drug transfer into breastmilk and determine subsequent infant exposure, biological samples will be collected from lactating women (blood and breastmilk) and infants (blood). The opportunistic design of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of antiretroviral drugs, and capitalization of procedures performed per SOC to maximize study efficiency and data collection and minimize potential risk to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in this vulnerable population in order to inform public health.

Tracking Information