HVTN 143/HPTN 109

A phase 1- clinical trial to evaluate the safety, tolerability, pharmacokinetics and tolerability of combinations of monoclonal antibodies VRC01.23LS, PGT121.414.LS, and PGDM1400LS administered via intravenous infusion in adults without HIV

Study Summary

Study Documents

HVTN 143/HPTN 109 Version 1.0

Study Details

Protocol Status: Withdrawn
Study Purpose:

A phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of monoclonal antibodies VRC01.23LS, PGT121.414.LS and PGDM1400LS administered via intravenous infusion in adults without HIV

Study Design:

Multicenter, randomized, open-label study

Study Population:

About 77 adult volunteers without HIV aged 18 through 50 years in the Republic of South Africa

Study Size:

77 participants

Study Duration:

6 months per participant in Part A and 12 months per participant in Part B of scheduled clinic visits. 22 months (includes enrollment, planned safety holds, and follow-up)

Treatment Regimen:

Part A
Group 1, VRC01.23LS, 5 mg/kg
Group 2, VRC01.23LS, 20 mg/kg
Group 3, VRC01.23LS, 40 mg/kg IV

Part B
Group 4, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 5 + 5 + 5 mg/kg IV
Group 5, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 20 + 5 + 5 mg/kg IV
Group 6, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 20 + 20 + 20 mg/kg IV
Group 7, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 40 + 5 + 5 mg/kg IV
Group 8, VRC01.23LS + PGT121.414.LS + PGDM1400LS, 40 + 40 + 40 mg/kg IV*

Primary Objectives:

• To evaluate the safety and tolerability of VRC01.23LS when administered alone via intravenous (IV) route (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, when administered consecutively via IV route (Part B)

• To evaluate the serum concentrations and pharmacokinetics (PK) of VRC01.23LS when administered alone via IV (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, after consecutive administration via IV route (Part B)

• To evaluate the individual mAb-specific serum neutralizing activity of VRC01.23LS when administered alone via IV (Part A) and of VRC01.23LS + PGT121.414.LS + PGDM1400LS, after consecutive administration via IV route (Part B)

Key Study Personnel

Personnel list available upon request.