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IMPAACT 2037
Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS alone and in combination with VRC07-523LS in Infants Exposed to HIV-1
Study Status
In Development
DAIDS Number
38962
Primary Protocol Team Members
Summary
IMPAACT 2037 is a Phase I, open-label, multi-site, non-comparative study of the potent anti-HIV neutralizing monoclonal antibodies PGT121.414.LS and VRC07-523LS. The study is designed to determine the safety and pharmacokinetic parameters of PGT121.414.LS alone and in combination with VRC07-523LS when administered subcutaneously soon after birth in infants at high risk for peripartum or breastfeeding HIV transmission.
Site selection was completed in October 2022 and was open to all IMPAACT sites. Planned sites are located in Brazil, Kenya, South Africa, and the United States.
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