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

Westat, Inc., Rockville MD

Investigators

Abstract

The IMPAACT Network is a cooperative group of institutions, investigators, and other collaborators mainly focused on evaluating potential therapies for HIV infection and its related symptoms and co-infections in infants, children, adolescents, and pregnant women. This includes clinical trials of HIV/AIDS interventions for the prevention of mother to child transmission. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that will advance the prevention and treatment of HIV and other infectious diseases and its complications for infants, children, adolescents, and pregnant/ postpartum women globally. The IMPAACT research agenda in this task order includes four scientific specific aims, which reflect the key areas of work. Those areas are HIV Treatment, HIV Prevention, HIV Cure, and HIV Complications. The Contractor shall coordinate, maintain and manage NICHD participating sites for 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. 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.