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Clinical Trial Summary

The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women, receiving antiretroviral drugs per SOC as prescribed by their healthcare provider, and their co-enrolled infants ≤180 days of age who receive maternal breastmilk.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04862975
Study type Observational
Source Duke University
Contact Jalila Guy, MPH
Phone 919-309-6515
Email [email protected]
Status Not yet recruiting
Phase
Start date October 28, 2021
Completion date May 25, 2023

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