HVTN 130/HPTN 089

A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants

Study Summary

Video created by the HIV Vaccine Trials Network (HVTN)

Study Details

Protocol Status: Closed to Follow Up
Study Purpose:

A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of combinations of monoclonal antibodies PGT121, PGDM1400, 10-1074, and VRC07-523LS administered via intravenous infusion in healthy, HIV-uninfected adult participants

Study Design:

Multicenter design; randomized by group in Groups 1-3; open label product administration in all groups

Study Population:

Healthy, HIV-1–uninfected volunteers aged 18 to 50 years, in the United States.

Study Size:

27 healthy, HIV-1–uninfected volunteers aged 18 to 50 years in the United States

Study Duration:

12 months per participant in Groups 1-3; 16 months per participant in Group 4
19 months total study duration (includes enrollment, planned safety holds, and follow-up)

Treatment Regimen:

PGT121 or PGDM1400 or 10-1074 administered in sequence via intravenous infusion (IV) with VRC07-523LS (2-mAb combinations); PGDM1400, PGT121, and VRC07-523LS administered in sequence via IV (3-mAb combination)

Primary Objectives:

Primary objective 1
To evaluate the safety and tolerability of PGT121 or PGDM1400 or 10-1074 when administered in sequence via intravenous infusion (IV) with VRC07-523LS (2-mAb combinations), and of PGDM1400, PGT121, and VRC07-523LS administered in sequence via IV (3-mAb combination)
Primary objective 2
To evaluate the serum concentrations and pharmacokinetics (PK) of PGT121, PGDM1400, 10-1074, and VRC07-523LS after a single 2-mAb administration and after each PGDM1400, PGT121, VRC07-523LS 3-mAb administration
Primary objective 3
To evaluate the individual mAb-specific serum neutralizing activity of PGT121, PGDM1400, 10-1074, and VRC07-523LS after a single 2-mAb administration and after each PGDM1400, PGT121, VRC07-523LS 3-mAb administration