Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1

Recruiting now · Phase 1

Conditions studied: HIV-1

In brief

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.

Key facts

Study ID

NCT06517693

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Starts

2026-01-05

Expected to finish

2028-06-30

Last updated by the study team

2026-08-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 x10\^9 cells/L)
• Absolute neutrophil count (ANC), normal or grade 1
• ≤24 hours old (≥4,000 cells/mm3 or ≥4.000 x10\^9 cells/L)
• >24 hours old (≥1,250 cells/mm3 or ≥1.250 x10\^9 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 had acute HIV during this pregnancy; or
• Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies/mL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies/mL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or
• Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.
• Cohorts 1 and 2, BF only:
• Per birthing parent's report, intends to breastfeed

You may not qualify if…

• 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.

Where it is running

• Site 5114, Bronx-Lebanon Hospital Center — The Bronx, New York, United States (enrolling)
• Site 5051, University of Florida Jacksonville — Jacksonville, Florida, United States (enrolling)
• Site 5052, University of Colorado Denver — Aurora, Colorado, United States (enrolling)
• Site 5128, Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States (enrolling)
• Site 5092, Johns Hopkins University Baltimore — Baltimore, Maryland, United States (enrolling)
• Site 6501, St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Site 5072, Hospital Federal dos Servidores do Estado — Rio de Janeiro, Brazil
• Site 5097, Hospital Geral De Nova Iguacu Brazil — Rio de Janeiro, Brazil
• Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho — Kericho, Kenya
• Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS — San Juan, Puerto Rico
• Site 8950, FAMCRU — Cape Town, Parrow Valley, South Africa
• Site 5112, David Geffen School of Medicine at UCLA — Los Angeles, California, United States
• Site 31890, Harare Family Care — Harare, Zimbabwe
• Site 5127, Pediatric Perinatal HIV — Miami, Florida, United States
• Site 5030, Emory University School of Medicine — Atlanta, Georgia, United States
• Site 5083, Rush University Cook County Hospital Chicago — Chicago, Illinois, United States
• Site 5013, Jacobi Medical Center Bronx — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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