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Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701

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ClinicalTrials.gov Identifier: NCT00453440
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This is a study to determine the prevalence of a genetic marker, HLA-B5701, in the UK population. HLA-B*5701 has been strongly associated with the risk of an allergic reaction to a HIV medicine, Abacavir. The allergic reaction is known as a hypersensitivity reaction.

The study is a prospective study inviting HIV-1 positive patients over the age of 18 years to participate. Each participant will complete one study visit. They will be asked for details of their background including their age, sex, ethnicity, country of origin and parental country of origin.

They will be asked to give two samples to test for the presence of the genetic marker HLA-B*5701. The two samples are:

  • A cheek swab
  • A blood sample

In selected centres patients may be asked to provide up to two additional blood samples. These samples will be used to help develop and validate new methods of determining HLA-B*5701 testing.


Condition or disease Intervention/treatment
Infection, Human Immunodeficiency Virus Procedure: Cheek swab & blood test

Study Design

Study Type : Observational
Actual Enrollment : 1502 participants
Official Title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
Actual Study Start Date : March 20, 2007
Primary Completion Date : August 10, 2007
Study Completion Date : August 10, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: Cheek swab & blood test
    Cheek swab & blood test

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of HLA-B*5701 in the UK population via central labs [ Time Frame: 2 Hours ]
    The widespread of HLA-B*5701 applied in the selected area in each participant of the UK population was tested via central labs. The result is summarized here.


Secondary Outcome Measures :
  1. Prevalence of HLA-B*5701 in major UK ethnotypes in the study population. [ Time Frame: 2 Hours ]
  2. Description of HLA-B*5701 in the UK population via local labs. [ Time Frame: 2 Hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00453440


Locations
United Kingdom
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH
GSK Investigational Site
Birmingham, Warwickshire, United Kingdom, B4 6DH
GSK Investigational Site
Birmingham, United Kingdom, WS2 9PS
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, E9 6SR
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
London, United Kingdom, W2 1NY
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00453440     History of Changes
Other Study ID Numbers: CNA109479
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by ViiV Healthcare:
HIV
HLA-B*5701
Abacavir hypersensitivity reaction
HIV Infection

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