HVTN 703 / HPTN 081 (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 in high-risk, HIV-uninfected women.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 Delivery
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 Delivery
ARMsExperimental
Official Code:
NCT02568215
Trial Sponsors:
NIAID
Start Date
End Date
May 1, 2016
March 3, 2021
Enrollment:1,924
Age range:
18 Years ↔
50 Years
Population:Cisgender Women