A Phase 1/2 Study of the Safety, Tolerability, and Pharmacokinetics of Cabotegravir in Neonates Exposed to HIV-1
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of cabotegravir in neonates exposed to human immunodeficiency virus (HIV)-1.
• At least 37 weeks gestation at delivery.
• \<=10 days of life.
• Birth weight at least 2 kg.
• At Entry, neonate has initiated standard of care Antiretroviral drug (ARV) prophylaxis.
• At Entry, neonate is generally healthy as determined by the site Investigator based on review of all available medical history information and physical examination findings.
• Mother is on a Dolutegravir (DTG) based regimen for a minimum of 4 weeks prior to delivery, regardless of maternal viral load.
• Mother is currently breastfeeding or plans to breastfeed infant.
• Mother is of legal age or circumstance to provide independent informed consent and is willing and able to provide documented informed consent for her and her infant's participation in this study.
• Mother has confirmed HIV-1 infection based on positive test results from 2 samples collected from 2 separate blood samples. Test results may be obtained from medical records or from testing performed during the study Screening period.