A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074
Status:Completed
Phase:I
Principal Investigator(s):Marina Caskey, MD
Objective:This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals. Last updated January 26, 2021
Prevention Option(s):Antibody Related Research
Study Design:Non-randomized, Open label
Arms and Assigned Interventions
DescriptionHIV-infected individuals Off ART, HIV-1 viral load < 100,000 copies/ml or On ART, HIV-1 viral load < 500 copies/ml
3 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-infected individuals Off ART, HIV-1 viral load < 100,000 copies/ml or On ART, HIV-1 viral load < 500 copies/ml
10 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-infected individuals Off ART, HIV-1 viral load < 100,000 copies/ml or On ART, HIV-1 viral load < 500 copies/ml
30 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-infected individuals Off ART, HIV-1 viral load < 100,000 copies/ml
30 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-uninfected individuals
3 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMs
DescriptionHIV-uninfected individuals
10 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-uninfected individuals
30 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
DescriptionHIV-uninfected individuals
30 mg/kg, single dose IV administration of 10-1074
Mode of Delivery
ARMsExperimental
Official Code:
NCT02511990
Trial Sponsors:
Rockefeller University
Start Date
End Date
July 23, 2015
December 6, 2017
Enrollment:33
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women, People Living with HIV