PHARMACOKINETIC AND SAFETY OF ANTIRETROVIRAL AND RELATED DRUGS LACTATING WOMEN AND BREASTFED INFANTS STUDY

NIH RePORTER · NIH · N01 · $385,623 · view on reporter.nih.gov ↗

Abstract

Scope: The purpose of this study is to characterize the pharmacokinetics (PK) of understudied drugs administered to lactating women receiving antiretroviral and other related drugs per standard of care as prescribed by their treating caregiver. In order 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 study design (“Opportunistic design”) of this study will allow for a minimal risk study, an expanded enrollment net, evaluation of off-patent drugs, and capitalization on procedures performed per standard of care to maximize study efficiency and data collection and minimize potential harm to participants. The data collected through this initiative will provide valuable PK, dosing, and safety information for drugs in vulnerable population.

Key facts

NIH application ID
10275630
Project number
275201800003I-0-759402000002-1
Recipient
DUKE UNIVERSITY
Principal Investigator
DANIEL BENJAMIN
Activity code
N01
Funding institute
NIH
Fiscal year
2020
Award amount
$385,623
Award type
Project period
2020-09-28 → 2022-09-27