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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

October 15, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

June 30, 2028

Conditions
HIV-1
Interventions
DRUG

PGT121.414.LS

Administered SC in the thigh

DRUG

VRC07-523LS

Administered SC in the thigh

Trial Locations (16)

7505

Site 8950, FAMCRU, Cape Town

10457

Site 5114, Bronx-Lebanon Hospital Center, The Bronx

10461

Site 5013, Jacobi Medical Center Bronx, The Bronx

20200

Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho, Kericho

21287

Site 5092, Johns Hopkins University Baltimore, Baltimore

30322

Site 5030, Emory University School of Medicine, Atlanta

32209

Site 5051, University of Florida Jacksonville, Jacksonville

33136

Site 5127, Pediatric Perinatal HIV, Miami

38105

Site 6501, St. Jude Children's Research Hospital, Memphis

60612

Site 5083, Rush University Cook County Hospital Chicago, Chicago

77030

Site 5128, Baylor College of Medicine/Texas Children's Hospital, Houston

80045

Site 5052, University of Colorado Denver, Aurora

90095

Site 5112, David Geffen School of Medicine at UCLA, Los Angeles

CEP 20221-903

Site 5072, Hospital Federal dos Servidores do Estado, Rio de Janeiro

CEP 26030-380

Site 5097, Hospital Geral De Nova Iguacu Brazil, Rio de Janeiro

00935

Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research, San Juan

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

collaborator

National Institute of Allergy and Infectious Diseases Vaccine Research Center (NIAID VRC)

UNKNOWN

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT06517693 - Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 | Biotech Hunter | Biotech Hunter