The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.
Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.
Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.
Infant was singleton or twin.
Infant's gestational age at birth was at least 36 weeks.
Birthing parent has received any investigational product during this pregnancy.
Infant has received any active or passive HIV immunotherapy or any investigational product.
At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.
Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator