Evaluating the Safety and Pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants

Maternal Inclusion Criteria:

• HIV infection
• Greater than or equal to 18 years of age
• Able and willing to provide signed informed consent for herself and her infant

Maternal Exclusion Criteria:

• Prior participation in any HIV-1 vaccine trial
• Receipt of any other active or passive HIV immunotherapy or investigational product during this pregnancy. (Note that administration of Food and Drug Administration [FDA]-approved antiretroviral (ARV) drugs when used to treat disease or prevent mother-to-child transmission were not considered investigational.)
• Documented or suspected serious medical illness or immediate life-threatening condition (other than HIV infection) in the mother that may have interfered with the ability to complete study requirements, as judged by the examining clinician

Infant Inclusion Criteria:

• Born to an HIV-1-infected woman who met all maternal inclusion/exclusion criteria listed above
• Gestational age, by best obstetrical, ultrasound, or infant exam, greater than or equal to 36 weeks
• Birth weight greater than or equal to 2.0 kg
• Allowable infant age at the time of enrollment was dependent on the Dose Group and Cohort:
• Dose Groups 1, 2, 4 and 5 (Cohort 1): Less than 72 hours of age, and anticipated availability to receive VRC immunization at less than 72 hours after birth.
• Dose Groups 3, 4 and 5 (Cohort 2): Less than or equal to 5 days of age, and anticipated availability to receive VRC immunization no more than 5 days after birth.
• At increased risk of HIV acquisition defined as documentation of one or more of the following risk factors:
• Dose Groups 1, 2, 4 and 5 (Cohort 1), only:
• Mother received no antiretroviral therapy (ART) during pregnancy or mother began or reinitiated ART (after an interruption of greater than 14 days), during the third trimester of pregnancy; or
• Mother with any detectable viral replication (HIV RNA above the limit of detection) at last measurement prior to delivery determined within 30 days of delivery; or
• Prolonged rupture of membranes (greater than 12 hours); or
• Mother with documented 2-class resistant HIV infection, which may have included historical documentation of lack of response
• Women who had a documented history of virologic failure while on non-nucleoside reverse transcriptase inhibitors (NNRTIs) but who had no resistance testing at the time of viral failure were considered to have NNRTI-documented resistance.
• Dose Groups 3, 4 and 5 (Cohort 2), only (African sites):
• Mother intended to breastfeed

Infant Exclusion Criteria:

• Receipt of any other active or passive HIV immunotherapy or investigational product other than the study vaccine (Note: Infant prophylaxis with any licensed ARV drugs clinically prescribed to prevent mother-to-child HIV transmission were not considered investigational.)
• Receipt of or anticipated need for blood products, immunoglobulin, or immunosuppressive therapy. This included infants who required hepatitis B immunoglobulin (HBIG) but did not require exclusion of infants who received hepatitis B vaccine in the newborn period.
• Documented or suspected serious medical illness, serious congenital anomaly, or immediate life-threatening condition in the infant that may have interfered with the ability to complete study requirements, as judged by the examining clinician
• Any requirement for supplemental oxygen beyond 24 hours of life or requiring supplemental oxygen at the time of the VRC01, VRC01LS, or VRC07-523LS dose
• Baseline laboratory results:
• Hemoglobin less than 12.0 g/dL
• Platelet count less than 100,000 cells/mm^3
• Absolute neutrophil count: for infants less than or equal to 24 hours old, less than 4,000 cells/mm^3; for infants greater than 24 hours old, less than 1,250 cells/mm^3
• Serum glutamic pyruvic transaminase (SGPT) greater than or equal to 1.25 times upper limit of age adjusted normal
• Dose Groups 1, 2, 4 and 5 (Cohort 1), only: Infant was breastfeeding at time of enrollment or moth