Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT06517693 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 48 participants
Start Date 2026-01-05
Est. Completion 2028-06-30
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06517693

The ClinicalTrials.gov registry entry for NCT06517693 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06517693 reports 17 study locations spanning 11 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06517693?

The interventions under investigation include: PGT121.414.LS (DRUG), VRC07-523LS (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06517693?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial