Actively Recruiting
Open-Label Phase I Study of Safety and Pharmacokinetics of PGT121.414.LS Alone and With VRC07-523LS in Infants Exposed to HIV-1
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-05-28
48
Participants Needed
17
Research Sites
26 weeks
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and pharmacokinetics of powerful anti-HIV monoclonal antibodies PGT121.414.LS alone and combined with VRC07-523LS in infants exposed to HIV-1. This open-label, phase I study focuses on newborns at risk of HIV infection, aiming to understand how these antibodies behave and their safety profile when given soon after birth. The study involves several groups receiving different dosing schedules of the antibodies. Some infants get a single subcutaneous dose of PGT121.414.LS at birth, while others receive two doses if still breastfeeding at Week 12. Another group receives both PGT121.414.LS and VRC07-523LS at birth, with some also receiving a second dose of both antibodies at Week 12 if breastfeeding continues. Dosing at birth is weight-based, but doses at Week 12 are fixed. Participants will be monitored through Week 96 with various safety assessments, including tracking adverse events and measuring antibody levels over time. Blood tests and clinical evaluations will measure how the antibodies are processed in the body and any reactions. The study team will review data on safety events, antibody concentrations, and any confirmed HIV infections during this period, helping to evaluate these treatments' profiles in newborns exposed to HIV.
CONDITIONS
Brief Title
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Birthing parent is legally able to provide informed consent and consents for infant participation.
- Birthing parent has confirmed HIV-1 infection with positive tests from two separate samples.
- Infant is a singleton or twin.
- Infant was born at least 36 weeks gestation.
- Infant weighs at least 2 kg at birth.
- Infant is less than 72 hours old at entry and expected to receive study product within 72 hours after birth.
- Infant has normal or grade 1 hemoglobin, platelets, absolute neutrophil count, and normal alanine transaminase at screening.
- Infant is generally healthy based on medical review and exam.
- Breastfeeding infants or those whose birthing parent intends to breastfeed (for breastfeeding cohorts).
- Formula-fed infants or those whose birthing parent does not intend to breastfeed (for formula-fed cohorts).
- Infant is at increased risk of HIV acquisition.
You will not qualify if you...
- Birthing parent received any investigational product during this pregnancy.
- Infant received any active or passive HIV immunotherapy or investigational product.
- Infant has documented positive HIV Nucleic Acid Test.
- Birthing parent or infant has any condition making participation unsafe or complicating study results, as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive one or two subcutaneous doses of PGT121.414.LS alone or in combination with VRC07-523LS starting soon after birth, with dosing based on weight at birth and possible second doses at Week 12 depending on breastfeeding status.
1 to 2 dosing visits plus follow-up visits through Week 24
Duration - Up to 72 weeks after treatment
Participants are monitored for safety and pharmacokinetics after treatment through Week 96.
Regular visits for assessments up to Week 96
Trial Site Locations
Total: 17 locations
1
Site 5112, David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Site 5052, University of Colorado Denver
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Site 5051, University of Florida Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
Site 5127, Pediatric Perinatal HIV
Miami, Florida, United States, 33136
Withdrawn
5
Site 5030, Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
6
Site 5083, Rush University Cook County Hospital Chicago
Chicago, Illinois, United States, 60612
Not Yet Recruiting
7
Site 5092, Johns Hopkins University Baltimore
Baltimore, Maryland, United States, 21287
Actively Recruiting
8
Site 5114, Bronx-Lebanon Hospital Center
The Bronx, New York, United States, 10457
Actively Recruiting
9
Site 5013, Jacobi Medical Center Bronx
The Bronx, New York, United States, 10461
Not Yet Recruiting
10
Site 6501, St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Not Yet Recruiting
11
Site 5128, Baylor College of Medicine/Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
12
Site 5072, Hospital Federal dos Servidores do Estado
Rio de Janeiro, Brazil, CEP 20221-903
Not Yet Recruiting
13
Site 5097, Hospital Geral De Nova Iguacu Brazil
Rio de Janeiro, Brazil, CEP 26030-380
Not Yet Recruiting
14
Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho
Kericho, Kenya, 20200
Not Yet Recruiting
15
Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS
San Juan, Puerto Rico, 00935
Not Yet Recruiting
16
Site 8950, FAMCRU
Cape Town, Parrow Valley, South Africa, 7505
Not Yet Recruiting
17
Site 31890, Harare Family Care
Harare, Zimbabwe
Not Yet Recruiting
Research Team
E
Emily Brown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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