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NCT06517693 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
A Phase 1 study of HIV-1, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 17
- Study locations
NCT06517693: Recruiting Phase 1 study of HIV-1, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT06517693 is a Phase 1 study of HIV-1 that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants, below the 131-participant average among 9 other HIV-1 trials with a reported enrollment target (63% lower). The trial reports 17 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06517693, a Phase 1 study of HIV-1, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 17
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG PGT121.414.LS
- DRUG VRC07-523LS
Study Locations (17)
Other
- Site 5072, Hospital Federal dos Servidores do Estado - Rio de Janeiro
- Site 5097, Hospital Geral De Nova Iguacu Brazil - Rio de Janeiro
- Site 5121, Kenya Medical Research Institute/Walter Reed Project Clinical Research Center, Kericho - Kericho
- Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research - San Juan
- Site 31890, Harare Family Care - Harare
Florida
- Site 5051, University of Florida Jacksonville - Jacksonville
- Site 5127, Pediatric Perinatal HIV - Miami
New York
- Site 5114, Bronx-Lebanon Hospital Center - The Bronx
- Site 5013, Jacobi Medical Center Bronx - The Bronx
California
- Site 5112, David Geffen School of Medicine at UCLA - Los Angeles
Colorado
- Site 5052, University of Colorado Denver - Aurora
Georgia
- Site 5030, Emory University School of Medicine - Atlanta
Illinois
- Site 5083, Rush University Cook County Hospital Chicago - Chicago
Maryland
- Site 5092, Johns Hopkins University Baltimore - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-01-05 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
What NCT06517693 shows while recruiting
NCT06517693 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 131-participant average among 9 other HIV-1 trials with a reported enrollment target (63% lower).
The record links to 1 condition, with HIV-1 appearing as the primary indexed condition, and to 2 interventions - of which PGT121.414.LS is the first listed.
NCT06517693 lists 17 locations in 11 states (Other, Florida, New York).
Frequently Asked Questions
What is clinical trial NCT06517693 about?
NCT06517693 is a clinical study titled "Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1". 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.
What is the current status of trial NCT06517693?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-01-05. Estimated completion is 2028-06-30.
What conditions does trial NCT06517693 study?
This clinical trial studies the following conditions: HIV-1.
What interventions are being tested in trial NCT06517693?
The interventions under investigation include: PGT121.414.LS (DRUG), VRC07-523LS (DRUG).
Who is sponsoring clinical trial NCT06517693?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06517693 being conducted?
This trial has 17 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06517693's enrollment target sits among peer trials
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