HVTN 127/HPTN 087
Status:Completed
Phase:I
Principal Investigator(s):Stephen Walsh; Cynthia Gay
Objective:The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses, routes, and dosing schedules to healthy, HIV-uninfected adults.
Last updated August 9, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants in Group 1 will receive 2.5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants in Group 2 will receive 5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 24, 48, and 72.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants in Group 3 will receive 20 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 24, 48, and 72.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants in Group 4 will receive 2.5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48 and 64.
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT03387150
Trial Sponsors:
NIAID (DAIDS-ES: 38458)
Start Date
End Date
February 8, 2018
December 7, 2020
Enrollment:124
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women