drugset
drugset / Trial / NCT03205917

A Clinical Trial of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-infected and HIV-uninfected Adults

NCT03205917 ↗

Phase 1 Completed 29 enrolled International AIDS Vaccine Initiative Beth Israel Deaconess Medical Center · collabOrlando Immunology Clinic · collabRagon Institute of MGH, MIT and Harvard · collabUniversity of Texas Health, Houston AIDS Research Team (HART) · collab
RandomizedParallel-groupDouble-blindPrevention

Summary

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400 and PGT121 and VRC07-523LS mAbs for HIV prevention and therapy.

Timeline

Start
2017-10-23
Primary completion
2020-04-20
Completion
2020-04-20

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject PGDM1400 Monoclonal antibody 3 mg/kg Intravenous
Subject PGDM1400 Monoclonal antibody 10 mg/kg Intravenous
Subject PGDM1400 Monoclonal antibody 20 mg/kg Intravenous
Subject PGDM1400 Monoclonal antibody 30 mg/kg Intravenous
Subject PGT121 Monoclonal antibody 3 mg/kg Intravenous
Subject PGT121 Monoclonal antibody 10 mg/kg Intravenous
Subject PGT121 Monoclonal antibody 20 mg/kg Intravenous
Subject PGT121 Monoclonal antibody 30 mg/kg Intravenous
Subject VRC07-523LS Monoclonal antibody 20 mg/kg Intravenous

Indications

HIV infectious disease