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IMPAACT 2037

Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414LS alone and in combination with VRC07-523LS in Infants Exposed to HIV-1

Study Status

In Development

DAIDS Number

38962

IND Number

TBD

Clinical Trials Link

TBD

Summary

IMPAACT 2037 is a Phase I, open-label, multi-site, non-comparative study of the potent anti-HIV neutralizing monoclonal antibodies PGT121.414LS and VRC07-523LS. The study is designed to determine the safety and pharmacokinetic parameters of PGT121.414LS alone and in combination with VRC07-523LS when administered subcutaneously soon after birth in infants at high risk for peripartum or breastfeeding HIV transmission.

The site selection process is ongoing and open to all IMPAACT sites.

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