Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men

PHASE2CompletedINTERVENTIONAL
Enrollment

2,699

Participants

Timeline

Start Date

April 6, 2016

Primary Completion Date

December 1, 2020

Study Completion Date

December 1, 2020

Conditions
HIV Infections
Interventions
BIOLOGICAL

VRC01

Administered by IV infusion; total dose will vary based on participant's weight

BIOLOGICAL

Placebo for VRC01

Sodium Chloride for Injection USP, 0.9%; administered by IV infusion

Trial Locations (26)

1

ACSA CRS, Iquitos

32

San Miguel CRS, Lima

1011

Lausanne Vaccine and Immunotherapy Center CRS, Lausanne

10027

Harlem Prevention Center CRS, New York

10065

New York Blood Center CRS, New York

10451

Bronx Prevention Research Center CRS, The Bronx

14642

University of Rochester Vaccines to Prevent HIV Infection CRS, Rochester

15081

CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS, Bellavista

19104

Penn Prevention CRS, Philadelphia

20006

George Washington Univ. CRS, Washington D.C.

27599

Chapel Hill CRS, Chapel Hill

30030

The Hope Clinic of the Emory Vaccine Center CRS, Decatur

35294

Alabama CRS, Birmingham

44106

Case Clinical Research Site, Cleveland

90024

UCLA Vine Street Clinic CRS, Los Angeles

94143

Bridge HIV CRS, San Francisco

30308-2012

The Ponce de Leon Center CRS, Atlanta

02115-6110

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

02215-4302

Fenway Health (FH) CRS, Boston

07103

New Jersey Medical School Clinical Research Center CRS, Newark

10032-3732

Columbia P&S CRS, New York

37232-2582

Vanderbilt Vaccine (VV) CRS, Nashville

98109-1024

Seattle Vaccine and Prevention CRS, Seattle

21040-360

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS, Rio de Janeiro

04

Barranco CRS, Lima

Lima 01

Via Libre CRS, Lima

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02716675 - Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection Among Men and Transgender Persons Who Have Sex With Men | Biotech Hunter | Biotech Hunter