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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: March 28, 2007
Last updated: August 31, 2010
Last verified: August 2010

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: None (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:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00453440

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, E9 6SR
GSK Investigational Site
London, United Kingdom, EC1A 7BE
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
Study Director: GSK Clinical Trials, BSc MBBS GlaxoSmithKline
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00453440     History of Changes
Other Study ID Numbers: CNA109479
Study First Received: March 28, 2007
Last Updated: August 31, 2010

Keywords provided by GlaxoSmithKline:
Abacavir hypersensitivity reaction

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immune System Diseases
Slow Virus Diseases processed this record on August 17, 2017