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Clinical trialNCT02716675CompletedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment2,699HIV Infections
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This study will evaluate the safety and efficacy of the human monoclonal antibody (mAb) VRC-HIVMAB060-00-AB (VRC01) in preventing HIV-1 infection among men and transgender (TG) persons who have sex with men, in North America, South America, and Switzerland.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Brazil
  • Instituto de Pesquisa Clinica Evandro Chagas (ipec) Crs

    Rio de Janeiro, Brazil

Peru
  • Acsa Crs

    Iquitos, Maynas, Peru

  • Citbm - Unidec, Centro de Investigaciones Tecnológicas, Biomédicas Y Medioambientales Crs

    Bellavista, Provincia Constitucional del Callao, Peru

  • Barranco Crs

    Lima, Peru

  • San Miguel Crs

    Lima, Peru

  • Via Libre Crs

    Lima, Peru

Switzerland
  • Lausanne Vaccine and Immunotherapy Center Crs

    Lausanne, Canton of Vaud, Switzerland

United States
  • Alabama Crs

    Birmingham, Alabama, United States

  • Ucla Vine Street Clinic Crs

    Los Angeles, California, United States

  • Bridge Hiv Crs

    San Francisco, California, United States

  • George Washington Univ. Crs

    Washington D.C., District of Columbia, United States

  • the Ponce de Leon Center Crs

    Atlanta, Georgia, United States

  • the Hope Clinic of the Emory Vaccine Center Crs

    Decatur, Georgia, United States

  • Brigham and Women'S Hospital Vaccine Crs (bwh Vcrs)

    Boston, Massachusetts, United States

  • Fenway Health (fh) Crs

    Boston, Massachusetts, United States

  • New Jersey Medical School Clinical Research Center Crs

    Newark, New Jersey, United States

  • Columbia P&s Crs

    New York, New York, United States

  • Harlem Prevention Center Crs

    New York, New York, United States

  • New York Blood Center Crs

    New York, New York, United States

  • University of Rochester Vaccines To Prevent Hiv Infection Crs

    Rochester, New York, United States

  • Bronx Prevention Research Center Crs

    The Bronx, New York, United States

  • Chapel Hill Crs

    Chapel Hill, North Carolina, United States

  • Case Clinical Research Site

    Cleveland, Ohio, United States

  • Penn Prevention Crs

    Philadelphia, Pennsylvania, United States

  • Vanderbilt Vaccine (vv) Crs

    Nashville, Tennessee, United States

  • Seattle Vaccine and Prevention Crs

    Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Placebo for VRC01VRC01
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Apr 2016
Primary completion
1 Dec 2020
Completion
1 Dec 2020
Last update posted
23 Feb 2022
Registered enrollment
2,699
Registry id
NCT02716675
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.