Phase I Study Evaluating Safety and Drug Levels of PGT121.414.LS Alone or With VRC07-523LS in Newborns Exposed to HIV-1

What this Trial Is About

Researchers are evaluating the safety and how the body processes two potent, broadly neutralizing anti-HIV monoclonal antibodies, PGT121.414.LS and VRC07-523LS, in newborn infants exposed to HIV-1. This open-label, phase I study focuses on newborns at increased risk of HIV infection and aims to understand the safety and drug levels of these antibodies when given alone or together soon after birth. Participants receive one or two subcutaneous injections of PGT121.414.LS alone or combined with VRC07-523LS. Doses are given at birth based on the infants weight, with a possible second dose at Week 12 if the infant is still breastfeeding. The study includes different groups based on feeding method and antibody combinations, with drug levels and safety assessed through Week 24. During the study, infants undergo medical evaluations including laboratory tests for blood counts and liver enzymes, physical exams, and monitoring for adverse events. Researchers measure drug concentrations and antibody levels up to Week 48 or Week 60, checking for any side effects or signs of HIV infection. Participation lasts up to about two years, allowing thorough safety and pharmacokinetic monitoring.

Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1