Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Start Date
1/5/2026
Completion Date
6/30/2028
Summary
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.
Detailed Description
This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
PGT121.414.LS
VRC07-523LS
Conditions
Locations
Site 5112, David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United States
Site 5052, University of Colorado Denver
Aurora, Colorado 80045
United States
Site 5051, University of Florida Jacksonville
Jacksonville, Florida 32209
United States
Site 5127, Pediatric Perinatal HIV
Miami, Florida 33136
United States
Site 5030, Emory University School of Medicine
Atlanta, Georgia 30322
United States
Site 5083, Rush University Cook County Hospital Chicago
Chicago, Illinois 60612
United States
Site 5092, Johns Hopkins University Baltimore
Baltimore, Maryland 21287
United States
Site 5114, Bronx-Lebanon Hospital Center
The Bronx, New York 10457
United States
Site 5013, Jacobi Medical Center Bronx
The Bronx, New York 10461
United States
Site 6501, St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
Site 5128, Baylor College of Medicine/Texas Children's Hospital
Houston, Texas 77030
United States
Site 5072, Hospital Federal dos Servidores do Estado
Rio de Janeiro, CEP 20221-903
Brazil
Site 5097, Hospital Geral De Nova Iguacu Brazil
Rio de Janeiro, CEP 26030-380
Brazil
Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho
Kericho, 20200
Kenya
Site 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS
San Juan, 00935
Puerto Rico
Site 8950, FAMCRU
Cape Town, Parrow Valley 7505
South Africa
Site 31890, Harare Family Care
Harare,
Zimbabwe