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A Phase I Study of the Safety, Tolerability, and Pharmacokinetics of Dolutegravir in Neonates Exposed to HIV-1

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IMPAACT 2023 is a phase I, multi-centered study of infants born to mothers living with HIV-1. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) given to infants during the first 4-6 weeks of life, with two sequential dosing cohorts stratified by maternal use of DTG. The purpose of the study is to propose an appropriate dose of DTG for neonates and infants born to mothers living with HIV-1.

Site selection was completed in March 2021. IMPAACT sites located in a country based on pharmaceutical partner plans for licensure of study product were invited to participate. Planned sites are located in Brazil, South Africa, Thailand, and the United States. 

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