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IMPAACT 2023

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

Study Status

In Development

Locality

US & Non-US

DAIDS Number

38637

Summary

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

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