MedTrace Logo

Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women

NCT02568215 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1924

Last updated 2022-02-23

Study results available
· View outcomes & findings →

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 in high-risk, HIV-uninfected women.

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
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2021-03-03
Completion
2021-03-03

Countries

  • Botswana
  • Kenya
  • Malawi
  • Mozambique
  • South Africa
  • Tanzania
  • Zimbabwe

Study Locations

More Related Trials

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 NCT02568215 on ClinicalTrials.gov