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NCT01218113 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons

A Phase 2 study of AIDS, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
191
Enrollment target
20
Study locations

NCT01218113 is a Phase 2 study of AIDS that has completed, run by GlaxoSmithKline. The registered enrollment target is 191 participants, below the 1,567-participant average among 13 other AIDS trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT01218113, a Phase 2 study of AIDS, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
191 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Conditions Studied

AIDS

Interventions

  • DRUG Placebo
  • BIOLOGICAL GSK Biologicals HIV Vaccine 732462

Study Locations (20)

Florida

  • GSK Investigational Site - Fort Lauderdale
  • GSK Investigational Site - Jacksonville
  • GSK Investigational Site - Orlando

New Jersey

  • GSK Investigational Site - Camden
  • GSK Investigational Site - Newark
  • GSK Investigational Site - Somers Point

Other

  • GSK Investigational Site - Bobigny
  • GSK Investigational Site - Créteil
  • GSK Investigational Site - Nantes

California

  • GSK Investigational Site - Bakersfield
  • GSK Investigational Site - Long Beach

Pennsylvania

  • GSK Investigational Site - Philadelphia
  • GSK Investigational Site - Philadelphia

District of Columbia

  • GSK Investigational Site - Washington D.C.

Nebraska

  • GSK Investigational Site - Omaha

Ohio

  • GSK Investigational Site - Columbus

Trial Details

FieldValue
Enrollment Target 191 participants
Start Date 2010-11-08
Est. Completion 2012-11-05
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01218113

The ClinicalTrials.gov registry entry for NCT01218113 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,567-participant average among 13 other AIDS trials with a reported enrollment target (88% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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

NCT01218113 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New Jersey, Other.

Frequently Asked Questions

What is clinical trial NCT01218113 about?

NCT01218113 is a clinical study titled "Efficacy and Safety of GSK Biologicals HIV Vaccine in Antiretroviral Therapy (ART)-naïve HIV-1 Infected Persons". This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (AR...

What is the current status of trial NCT01218113?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2010-11-08. Estimated completion is 2012-11-05.

What conditions does trial NCT01218113 study?

This clinical trial studies the following conditions: AIDS.

What interventions are being tested in trial NCT01218113?

The interventions under investigation include: Placebo (DRUG), GSK Biologicals HIV Vaccine 732462 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01218113?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01218113 being conducted?

This trial has 20 study locations across California, District of Columbia, Florida, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.