Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1 (NCT06517693)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Site 5112, David Geffen School of Medicine at UCLA — Los Angeles, California
Age range: Not specified to 72 Hours
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Site 5112, David Geffen School of Medicine at UCLA — Los Angeles, California
- Site 5052, University of Colorado Denver — Aurora, Colorado
- Site 5051, University of Florida Jacksonville — Jacksonville, Florida
- Site 5127, Pediatric Perinatal HIV — Miami, Florida
- Site 5030, Emory University School of Medicine — Atlanta, Georgia
- Site 5083, Rush University Cook County Hospital Chicago — Chicago, Illinois
- Site 5092, Johns Hopkins University Baltimore — Baltimore, Maryland
- Site 5114, Bronx-Lebanon Hospital Center — The Bronx, New York
- Site 5013, Jacobi Medical Center Bronx — The Bronx, New York
- Site 6501, St. Jude Children's Research Hospital — Memphis, Tennessee
- Site 5128, Baylor College of Medicine/Texas Children's Hospital — Houston, Texas
- Site 5072, Hospital Federal dos Servidores do Estado — Rio de Janeiro, Brazil
- 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 32513, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research Network CRS — San Juan, Puerto Rico
- Site 8950, FAMCRU — Cape Town, Parrow Valley
- Site 31890, Harare Family Care — Harare,
📞 Contact the Study Coordinator
Phone: (919) 321-3806
Email: embrown@fhi360.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.