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NCT02411539 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
13
Study locations

NCT02411539 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 13 study locations across 13 states.

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The verdict

NCT02411539, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VRC01

Study Locations (13)

California

  • UCSD Antiviral Research Center CRS - San Diego

Colorado

  • University of Colorado Hospital CRS - Aurora

Illinois

  • Northwestern University CRS - Chicago

Maryland

  • Johns Hopkins University CRS - Baltimore

Massachusetts

  • Massachusetts General Hospital CRS (MGH CRS) - Boston

Missouri

  • Washington University Therapeutics (WT) CRS - St Louis

New York

  • University of Rochester Adult HIV Therapeutic Strategies Network CRS - Rochester

North Carolina

  • Chapel Hill CRS - Chapel Hill

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2015-08-25
Est. Completion 2016-09-29
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT02411539

The ClinicalTrials.gov registry entry for NCT02411539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02411539 reports 13 study locations spanning 13 distinct geographic areas - top geographies include California, Colorado, Illinois.

Frequently Asked Questions

What is clinical trial NCT02411539 about?

NCT02411539 is a clinical study titled "Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)". The purpose of this study was to evaluate the safety, tolerability, and effect of an experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected with HIV who were receiving antiretroviral therapy (ART).

What is the current status of trial NCT02411539?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2015-08-25. Estimated completion is 2016-09-29.

What conditions does trial NCT02411539 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT02411539?

The interventions under investigation include: Placebo (BIOLOGICAL), VRC01 (BIOLOGICAL).

Who is sponsoring clinical trial NCT02411539?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02411539 being conducted?

This trial has 13 study locations across California, Colorado, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.