National Institute of Allergy and Infectious Diseases (NIAID)
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.
This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.
Inclusion Criteria: * 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. * At birth, infant's weight was at least 2 kg. * At entry, infant is less than 72 hours of age and is anticipate…
Administered SC in the thigh
Administered SC in the thigh