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
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Study Details
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
Multicenter design; randomized by group in Groups 1-3; open label product administration in all groups
Healthy, HIV-1–uninfected volunteers aged 18 to 50 years, in the United States.
27 healthy, HIV-1–uninfected volunteers aged 18 to 50 years in the United States
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)
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 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