A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

Phase 1/2 Completed 19 enrolled International AIDS Vaccine Initiative Beth Israel Deaconess Medical Center · collab Houston AIDS Research Team · collab National Institute of Allergy and Infectious Diseases (NIAID) · collab Orlando Immunology Center · collab

Non-randomizedParallel-groupOpen-labelOther

Summary

This is a Phase 1/2a open label study to evaluate the safety, tolerability, pharmacokinetics and anti-viral activity of PGT121, VRC07-523LS and PGDM1400 for HIV prevention and therapy.

Timeline

Start: 2018-12-03
Primary completion: 2021-10-25
Completion: 2022-05-02

Publications

Julg B, Walker-Sperling VEK, Wagh K, Aid M, Stephenson KE, Zash R, Liu J, Nkolola JP, Hoyt A, Castro M, Serebryannyy L, Yanosick K, Speidel T, Borducchi EN, Murzda T, Maxfield L, Arduino R, McDermott AB, Gama L, Giorgi EE, Koup RA, Seaman MS, Rolle CP, DeJesus E, Li W, Korber B, Barouch DH. Safety and antiviral effect of a triple combination of HIV-1 broadly neutralizing antibodies: a phase 1/2a trial. Nat Med. 2024 Dec;30(12):3534-3543. doi: 10.1038/s41591-024-03247-5. Epub 2024 Sep 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PGDM1400	Monoclonal antibody	20 mg/kg	Intravenous
Comparator	PGT121	Monoclonal antibody	20 mg/kg	Intravenous
Comparator	PGT121	Monoclonal antibody	30 mg/kg	Intravenous
Comparator	VRC07-523LS	Monoclonal antibody	20 mg/kg	Intravenous
Comparator	VRC07-523LS	Monoclonal antibody	30 mg/kg	Intravenous

A Phase 1/2a Study of PGT121, VRC07-523LS and PGDM1400 Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

Summary

Timeline

Publications

Drugs

Indications