Clinical trialNCT06517693RecruitingPhase 1Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment48HIV-1

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Coleen Cunningham
University of California, Irvine
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

17 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil

Site 5072, Hospital Federal Dos Servidores Do Estado
Rio de Janeiro, Brazil
Not, yet, recruiting
Site 5097, Hospital Geral de Nova Iguacu Brazil
Rio de Janeiro, Brazil
Not, yet, recruiting

Kenya

Site 5121, Kenya Medical Research Institute/walter Reed Project Clinical Research Center, Kericho
Kericho, Kenya
Not, yet, recruiting

Puerto Rico

Site 32513, Impaact/gamma Project/upr Pediatric Hiv/aids Research Network Crs
San Juan, Puerto Rico
Not, yet, recruiting

South Africa

Site 8950, Famcru
Cape Town, Parrow Valley, South Africa
Not, yet, recruiting

United States

Site 5112, David Geffen School of Medicine at Ucla
Los Angeles, California, United States
Not, yet, recruiting
Site 5052, University of Colorado Denver
Aurora, Colorado, United States
Recruiting
Site 5051, University of Florida Jacksonville
Jacksonville, Florida, United States
Recruiting
Site 5127, Pediatric Perinatal Hiv
Miami, Florida, United States
Withdrawn
Site 5030, Emory University School of Medicine
Atlanta, Georgia, United States
Not, yet, recruiting
Site 5083, Rush University Cook County Hospital Chicago
Chicago, Illinois, United States
Withdrawn
Site 5092, Johns Hopkins University Baltimore
Baltimore, Maryland, United States
Recruiting
Site 5013, Jacobi Medical Center Bronx
The Bronx, New York, United States
Not, yet, recruiting
Site 5114, Bronx-Lebanon Hospital Center
The Bronx, New York, United States
Recruiting
Site 6501, St. Jude Children'S Research Hospital
Memphis, Tennessee, United States
Not, yet, recruiting
Site 5128, Baylor College of Medicine/texas Children'S Hospital
Houston, Texas, United States
Recruiting

Zimbabwe

Site 31890, Harare Family Care
Harare, Zimbabwe
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PGT121.414.LSVRC07-523LS

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 5 Jan 2026
Primary completion: 31 Dec 2027
Completion: 30 Jun 2028
Last update posted: 4 Aug 2026
Registered enrollment: 48
Registry id: NCT06517693

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.