HVTN 104
Status:Completed
Phase:I
Principal Investigator(s):Kenneth Mayer, The Fenway Institute
Objective:The purpose of this study is to evaluate the safety, tolerability, and drug levels of five different schedules for the intravenous (IV) and subcutaneous (SC) administration of a human monoclonal antibody (VRC-HIVMAB060-00-AB [VRC01]) against HIV in healthy, HIV-uninfected adults. Last updated January 30, 2022
Prevention Option(s):Antibody Related Research
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionVRC01 (6 IV infusions):
Participants will receive an IV infusion of 40 mg/kg of VRC01 administered in 100 mL of normal saline over 1 hour at Day 0, followed by IV infusions of 20 mg/kg of VRC01 administered in 100 mL of normal saline over 1 hour at Days 28, 56, 84, 112, and 140.
Mode of DeliverySubcutaneous
ARMsExperimental
Description(3 IV infusions):
Participants will receive an IV infusion of 40 mg/kg of VRC01 administered in 100 mL of normal saline over 1 hour at Days 0, 56, and 112.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionVRC01 (1 IV infusion plus multiple SC injections):
Participants will receive an IV infusion of 40 mg/kg of VRC01 administered in 100 mL of normal saline at Week 0, followed by SC injection of 5 mg/kg of VRC01 administered every 2 weeks for 20 weeks.
Mode of DeliverySubcutaneous
ARMsExperimental
Description10 mg/kg of VRC01 (3 IV infusions):
Participants will receive an IV infusion of 10 mg/kg of VRC01 administered in 100 mL of normal saline at Months 0, 2, and 4.
Mode of DeliverySubcutaneous
ARMsExperimental
Description30 mg/kg of VRC01 (3 IV infusions):
Participants will receive an IV infusion of 30 mg/kg of VRC01 administered in 100 mL of normal saline at Months 0, 2, and 4.
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT02165267
Trial Sponsors:
NIAID
Start Date
End Date
August 31, 2014
February 2, 2016
Enrollment:88
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women