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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

NCT02716675 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2699

Last updated 2022-02-23

Study results available
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Summary

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.

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lawrence Corey · HVTN; FHCRC

  • Myron Cohen · HPTN; University of North Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-06
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • United States
  • Brazil
  • Peru
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716675 on ClinicalTrials.gov