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COMPLETED Phase 2

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

NCT01218113 · View on ClinicalTrials.gov ↗

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

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

558 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 191 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01218113 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New Jersey, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01218113?

The interventions under investigation include: Placebo (DRUG), GSK Biologicals HIV Vaccine 732462 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01218113?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial