A Study to Investigate Cabotegravir for Neonates Exposed to HIV-1

Exclusion Criteria24

• Medical conditions
• Severe congenital malformation or other medical condition not compatible with life or that would interfere with study participation or interpretation, as judged by examining clinician.
• Known maternal-fetal blood group incompatibility which can result in hemolytic disease of the newborn.
• Known family history of G6PD deficiency.
• Prior/Concomitant therapy
• Mother who has previously received, is receiving, or will be receiving CAB post-partum.
• Neonate or breastfeeding mother is receiving any disallowed medication.
• Prior/Concurrent clinical study participation
• Neonate has exposure to other investigational drugs that might interfere with study intervention metabolism.
• Diagnostic assessments
• Mother has known Integrase strand transfer inhibitor (InSTI) resistance.
• At Entry, neonate with a confirmed, documented positive HIV Nucleic acid amplification test (NAAT) test result.
• At Screening, neonate has any of the following laboratory test results:
• Alanine transaminase or Aspartate aminotransferase of more than 2.5 x Upper limit of normal (ULN).
• Total bilirubin in range for phototherapy at Entry.
• Hemoglobin <13.0 g/dL.
• Decreased white blood cells Grade 3 or above.
• Platelets <50 000 cells/mm3
• Creatinine value more than 1.3 the ULN for postnatal age as defined in Division of AIDS (DAIDS)
• Albumin Grade 3 or higher.
• Direct bilirubin Grade 3 and above.
• Any other Grade ≥3 event on DAIDS toxicity table
• Mother or neonate has a condition that, in the site Investigator or designee's opinion, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• At screening, QT interval corrected using Fridericia's formula >450 msec.