HVTN 116
Status:Completed
Phase:I
Principal Investigator(s):
Objective:This study will evaluate the safety, pharmacokinetics, and antiviral activity of VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of healthy, HIV-uninfected adults. Last updated January 21, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive 10 mg/kg of VRC01 at Months 0, 2, 4, and 6.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive 30 mg/kg of VRC01 at Months 0, 2, 4, and 6.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive 30 mg/kg of VRC01LS at Months 0, 3, and 6.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive 30 mg/kg of VRC01 at Month 0.
Mode of DeliverySubcutaneous
ARMsExperimental
DescriptionParticipants will receive 30 mg/kg of VRC01LS at Month 0.
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT02797171
Trial Sponsors:
DAIDS, HVTN, VRC
Start Date
End Date
March 1, 2017
June 5, 2019
Enrollment:80
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women