NCT03205917

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

A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGDM1400 and PGT121 and VRC07-523LS Monoclonal Antibodies in HIV-uninfected and HIV-infected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGDM1400, PGT121 and VRC07-523LS mAbs for HIV prevention and therapy. PGDM1400, PGT121 and VRC07-523LS mAbs are recombinant human IgG1 monoclonal antibodies that target V1V2 (PGDM1400), a V3 glycan-dependent epitope (PGT121) and the CD4 binding site (VRC07-523LS) epitope region of the HIV envelope protein. PGT121, PGDM1400 and VRC07-523LS mAb were chosen for this study because of their potency, their ability to neutralize a wide array of cross-clade HIV viruses in a complementary pattern and their proven antiviral activity in animal studies e.g., their capacity to robustly prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	PGDM1400/Placebo (3mg/kg IV)	3/1 (6/2 if DLT)
BIOLOGICAL	PGDM1400/Placebo (10mg/kg IV)	3/1 (6/2 if DLT)
BIOLOGICAL	PGDM1400/Placebo (30mg/kg IV)	3/1 (6/2 if DLT)
BIOLOGICAL	PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV)	3/1 (6/2 if DLT)
BIOLOGICAL	PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)	3/1 (6/2 if DLT);
BIOLOGICAL	PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV)	3/1 (6/2 if DLT)
BIOLOGICAL	PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV)	3 (max 9)
BIOLOGICAL	PGDM1400 + PGT121 (MTD IV)	3 (max 9)

Timeline

• Start date: 2017-10-23
• Primary completion: 2020-04-20
• Completion: 2020-04-20
• First posted: 2017-07-02
• Last updated: 2020-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study