HVTN 704/HPTN 085 (The AMP Study)
Status:Completed
Phase:IIb
Principal Investigator(s):Lawrence Corey, Myron Cohen
Objective:This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North and South America.The study also looks at the safety of these antibody infusions and it looks over time at how much antibody is in the blood of study participants receiving different amounts or doses of the antibody.Read more in Understanding Results of the AMP Trials.
Last updated August 9, 2022
Prevention Option(s):Antibody Related Research
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive an intravenous (IV) infusion of 10 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Mode of DeliveryIV Infusions
ARMsExperimental
DescriptionParticipants will receive an IV infusion of 30 mg/kg of VRC01 over about 30 to 60 minutes at Weeks 0, 8, 16, 24, 32, 40, 48, 56, 64, and 72.
Mode of DeliveryIV Infusions
ARMsExperimental
Official Code:
NCT02716675
Trial Sponsors:
NIAID
Start Date
End Date
April 6, 2016
December 1, 2020
Enrollment:2,699
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Gay and Bisexual Men Who Have Sex with Men, Transgender Men, Transgender Women