OPEN-LABEL PHASE I STUDY OF THE SAFETY AND PHARMACOKINETICS OF NEUTRALIZING MONOCLONAL ANTIBODIES IN INFANTS EXPOSED TO HIV-I

NIH RePORTER · NIH · N01 · $2,505,456 · view on reporter.nih.gov ↗

Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) provides clinical trial sites to the International Maternal Pediatric Adolescent AIDS Clinical Trials Group (IMPAACT). 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. The IMPAACT Network goal is to conduct high quality clinical trials and/or protocols that will advance the prevention and treatment of HIV 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 the IMPAACT 2037 study which is a Phase I, Open-Label Safety and Pharmacokinetics multi-site non-comparative study of the potent anti-HIV neutralizing monoclonal antibodies in infants.

Key facts

NIH application ID
11181769
Project number
75N94023D00001-0-759402400001-1
Recipient
WESTAT, INC.
Principal Investigator
BARBARA DRIVER
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$2,505,456
Award type
Project period
2024-03-01 → 2029-02-28