Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults

PHASE1CompletedINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

February 29, 2016

Study Completion Date

February 29, 2016

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC01

Administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP) or administered SC by needle and syringe injection.

BIOLOGICAL

SC placebo for VRC01

Sterile, buffered aqueous solution of 25 mM Sodium Citrate, 50 mM Sodium Chloride, 150 mM L-Arginine Hydrochloride, 10% Dextran 40, and 0.005% Polysorbate 80 at pH 5.8 administered SC by needle and syringe injection

BIOLOGICAL

IV placebo for VRC01

Sodium Chloride for Injection 0.9%, USP administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP)

Trial Locations (6)

10065

New York Blood Center CRS, New York

19104

Penn Prevention CRS, Philadelphia

44106

Case Clinical Research Site, Cleveland

02115-6110

Brigham and Women's Hospital Vaccine CRS (BWH VCRS), Boston

02215-4302

Fenway Health (FH) CRS, Boston

10032-3732

Columbia P&S CRS, New York

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02165267 - Evaluating the Safety and Drug Levels of an Antibody Against HIV in Healthy, HIV-Uninfected Adults | Biotech Hunter | Biotech Hunter