Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

August 25, 2015

Primary Completion Date

April 15, 2016

Study Completion Date

September 29, 2016

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC01

40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

BIOLOGICAL

Placebo

Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump

Trial Locations (13)

14642

University of Rochester Adult HIV Therapeutic Strategies Network CRS, Rochester

15213

University of Pittsburgh CRS, Pittsburgh

21205

Johns Hopkins University CRS, Baltimore

27599

Chapel Hill CRS, Chapel Hill

37204

Vanderbilt Therapeutics (VT) CRS, Nashville

43210

Ohio State University CRS, Columbus

60611

Northwestern University CRS, Chicago

77030

Houston AIDS Research Team CRS, Houston

80045

University of Colorado Hospital CRS, Aurora

92103

UCSD Antiviral Research Center CRS, San Diego

02114

Massachusetts General Hospital CRS (MGH CRS), Boston

63110-1010

Washington University Therapeutics (WT) CRS, St Louis

98104-9929

University of Washington AIDS CRS, Seattle

All Listed Sponsors
collaborator

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02411539 - Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART) | Biotech Hunter | Biotech Hunter