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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481390
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : June 8, 2011
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Brief Summary:

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.

Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus I HIV Infection HIV-1 Infection Procedure: Cheek cells sample Procedure: Blood sample

Study Type : Observational
Actual Enrollment : 1110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients
Study Start Date : June 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Procedure: Blood sample
Blood sample

Primary Outcome Measures :
  1. Prevalence of HLA-B*5701 in European HIV-1 population

Secondary Outcome Measures :
  1. Prevalence of HLA-B*5701 in major European ethnotypes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-1 infected adults, out patients department

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481390

GSK Investigational Site
Helsinki, Finland, 00029
GSK Investigational Site
Dublin, Ireland, 8
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
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
Amadora, Portugal, 2720-276
GSK Investigational Site
Lisboa, Portugal, 1150
GSK Investigational Site
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
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00481390     History of Changes
Other Study ID Numbers: CNA110329
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: June 2011

Keywords provided by GlaxoSmithKline:
Treatment Experienced
Treatment Naive

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases