NCT06517693

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Accepted

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.

Detailed description

This is an open-label, phase I study of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS administered soon after birth in infants exposed to HIV-1. The study is designed to assess the safety and pharmacokinetics (PK) profile of one and two subcutaneous (SC) doses of PGT121.414.LS alone or in combination with VRC07-523LS through Week 12 and Week 24, respectively.

Conditions

• HIV-1

Interventions

Type	Name	Description
DRUG	PGT121.414.LS	Administered SC in the thigh
DRUG	VRC07-523LS	Administered SC in the thigh

Timeline

• Start date: 2026-01-05
• Primary completion: 2027-12-31
• Completion: 2028-06-30
• First posted: 2024-07-24
• Last updated: 2026-03-17

Locations

17 sites across 6 countries: United States, Brazil, Kenya, Puerto Rico, South Africa, Zimbabwe

Regulatory

• FDA-regulated drug study