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IMPAACT 2023

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

Study Status

In Development

DAIDS Number

38637

IND Number

110847

Summary

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.

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