3BNC117 and 10-1074 in HIV Uninfected Adults
Status:Completed
Phase:I
Principal Investigator(s):Yehuda Cohen, MD
Objective:This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074, when given in combination, in human immunodeficiency virus (HIV)-uninfected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use as prophylaxis against HIV infection in healthy HIV-uninfected individuals at risk for HIV infection.Last updated January 21, 2022
Prevention Option(s):Antibody Related Research
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will be randomized in a 3:1 ratio to receive one intravenous infusion of 3BNC117 and one intravenous infusion of 10-1074, each dosed at 10 mg/kg OR placebo (sterile saline), on day 0.
Mode of Delivery
ARMsExperimental
DescriptionParticipants will be randomized in a 3:1 ratio to receive three intravenous infusions of 3BNC117 and three intravenous infusions of 10-1074, each dosed at 3 mg/kg OR placebo (sterile saline), on day 0, week 8, and week 16.
Mode of Delivery
ARMsExperimental
DescriptionParticipants will be randomized in a 3:1 ratio to receive three intravenous infusions of 3BNC117 and three intravenous infusions of 10-1074, each dosed at 10 mg/kg OR placebo (sterile saline), on day 0, week 8, and week 16.
Mode of Delivery
ARMsExperimental
Official Code:
NCT02824536
Trial Sponsors:
Rockefeller University
Start Date
End Date
June 23, 2016
January 9, 2018
Enrollment:24
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women