Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

June 7, 2011 updated by: GlaxoSmithKline

Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients

This study is a cross-sectional observational study to evaluate the prevalence of HLA-B*5701 in the European area and in major European ethnotypes.

Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by local and central laboratories.

In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B*5701 status.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • Ireland
      • Dublin, Ireland, 8
        • GSK Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Arnhem, Netherlands, 6815 AD
        • GSK Investigational Site
      • Den Haag, Netherlands, 2545 CH
        • GSK Investigational Site
      • Den Haag, Netherlands, 2512 VA
        • GSK Investigational Site
      • Enschede, Netherlands, 7511JX
        • GSK Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 GD
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3078 HT
        • GSK Investigational Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • GSK Investigational Site
      • Lisboa, Portugal, 1150
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, 3010
        • GSK Investigational Site
      • La Chaux-de-Fonds, Switzerland, CH 2301
        • GSK Investigational Site
      • Lausanne, Switzerland, 1011
        • GSK Investigational Site
      • Lugano, Switzerland, 6900
        • GSK Investigational Site
      • Zuerich, Switzerland, 8091
        • GSK Investigational Site
      • Zürich, Switzerland, 8030
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HIV-1 infected adults, out patients department

Description

Inclusion criteria:

  • HIV-1 infected patients over the age of 18 years
  • Patient is willing and able to understand and provide written informed consent

Exclusion criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HIV-1 infected adults
Procedure: Blood sample
Blood sample
Procedure: Cheek cells sample
Cheek cells sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Prevalence of HLA-B*5701 in European HIV-1 population

Secondary Outcome Measures

Outcome Measure
Prevalence of HLA-B*5701 in major European ethnotypes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNA110329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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