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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00453440
First received: March 28, 2007
Last updated: August 31, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
HIV Infection
Infection, Human Immunodeficiency Virus
 Procedure: Cheek swab & blood test
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Prevalence of HLA-B*5701 in the UK population via central labs [ Time Frame: 2 Hours ]

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

Enrollment: 1569
Study Start Date: March 2007
Intervention Details:
    Procedure: Cheek swab & blood test
    Other Name: Cheek swab & blood test
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453440

Locations
United Kingdom
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH
GSK Investigational Site
Birmingham, United Kingdom, WS2 9PS
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
London, United Kingdom, W2 1NY
GSK Investigational Site
London, United Kingdom, SE1 7EH
GSK Investigational Site
London, United Kingdom, EC1A 7BE
GSK Investigational Site
London, United Kingdom, E9 6SR
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, BSc MBBS GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00453440     History of Changes
Other Study ID Numbers: CNA109479
Study First Received: March 28, 2007
Last Updated: August 31, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
HIV
HLA-B*5701
Abacavir hypersensitivity reaction

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

ClinicalTrials.gov processed this record on May 19, 2013