Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Public ClinicalTrials.gov record NCT06517693. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06517693
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 48 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 72 Hours
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2026
- Primary completion
- Dec 30, 2027
- Completion
- Jun 29, 2028
- Last update posted
- Aug 24, 2026
2026 – 2028
United States locations
- U.S. sites
- 11
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 5112, David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | Not yet recruiting |
| Site 5052, University of Colorado Denver | Aurora | Colorado | 80045 | Recruiting |
| Site 5051, University of Florida Jacksonville | Jacksonville | Florida | 32209 | Recruiting |
| Site 5127, Pediatric Perinatal HIV | Miami | Florida | 33136 | Withdrawn |
| Site 5030, Emory University School of Medicine | Atlanta | Georgia | 30322 | Not yet recruiting |
| Site 5083, Rush University Cook County Hospital Chicago | Chicago | Illinois | 60612 | Withdrawn |
| Site 5092, Johns Hopkins University Baltimore | Baltimore | Maryland | 21287 | Recruiting |
| Site 5114, Bronx-Lebanon Hospital Center | The Bronx | New York | 10457 | Recruiting |
| Site 5013, Jacobi Medical Center Bronx | The Bronx | New York | 10461 | Not yet recruiting |
| Site 6501, St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | Not yet recruiting |
| Site 5128, Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77030 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06517693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 24, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06517693 live on ClinicalTrials.gov.