Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS 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.
• At birth, infant's weight was at least 2 kg.
• At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.
• At screening, infant has the following laboratory test results:
  • Hemoglobin, normal or grade 1 (≥13 g/dL or ≥8.05 mmol/L)
  • Platelets, normal or grade 1 (≥100,000 cells/mm3 or ≥100.000 x109 cells/L)
  • Absolute neutrophil count (ANC), normal or grade 1
    1. ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x109 cells/L)
    2. >24 hours old (≥1,250 cells/mm3 or ≥1.250 x109 cells/L)
  • Alanine transaminase (ALT), normal (<1.25 x ULN)
• At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.
• Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.
• Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.
• At entry, infant is at increased risk of HIV acquisition.

Cohorts 1 and 2, Strata FF only:

• Birthing parent diagnosed with HIV during this pregnancy; or
• Birthing parent received no ART during this pregnancy or birthing parent began or reinitiated ART (after an interruption of greater than 14 days) after 14 weeks of this pregnancy; or
• Birthing parent with any detectable viral replication (HIV RNA above the limit of detection) after 14 weeks of pregnancy; or
• Prolonged rupture of membranes (greater than 12 hours); or
• Birthing parent diagnosed with syphilis during this pregnancy; or
• Birthing parent with documented* resistance to any ARV *Birthing parents who have a documented history of virologic failure while on lamivudine or NVP but who had no resistance testing at the time of viral failure will be considered to have documented resistance to these drugs.

Cohorts 1 and 2, BF only:

• Per birthing parent's report, intends to breastfeed

• 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.