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IMPAACT 2041

Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir Initiated in Pregnancy in People with Hepatitis C with and without HIV

Study Status

In Development

DAIDS Number

39052

IND Number

TBD

Clinical Trials Link

TBD

Summary

IMPAACT 2041 is a Phase I/II Study of the Pharmacokinetics and Safety of Glecaprevir/Pibrentasvir in People with Hepatitis C During Pregnancy. The study is designed to evaluate the pharmacokinetics and safety of GLE/PIB during pregnancy and postpartum, and will follow pregnant people and their infants through three months postpartum. Site selection was completed in July 2023 and was opened to IMPAACT sites located in the United States only. Only US sites were invited to participate due to the expected availability of GLE/PIB.

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