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

Key Study Personnel

Wairimu Chege, DAIDS Medical Officer
Jontraye Davis, Protocol Team Member
Bonnie Dye, LOC Clinical Research Manager
Theresa Gamble, LOC Clinical Research Manager
Margarita Gomez, DAIDS Medical Officer
Abraham Johnson, Protocol Team Member
Sharon Mannheimer, Protocol Chair
David Montefiori, LC Representative
Carmen Paez, HVTN Clinical Trials Manager
Estelle Piwowar-Manning, LC Representative
Magdalena Sobieszczyk, Protocol Chair
India Tindale, HVTN Clinical Trials Manager