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

March 28, 2007
August 31, 2010
March 2007
Not Provided
Prevalence of HLA-B*5701 in the UK population via central labs [ Time Frame: 2 Hours ]
Prevalence of HLA-B*5701 in the UK population via central labs
Complete list of historical versions of study NCT00453440 on ClinicalTrials.gov Archive Site
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 ]
  • 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.
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Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • HIV Infection
  • Infection, Human Immunodeficiency Virus
Procedure: Cheek swab & blood test
Other Name: Cheek swab & blood test
Not Provided
Orkin C, Sadiq ST, Rice L, Jackson F; UK EPI team. Prospective epidemiological study of the prevalence of human leukocyte antigen (HLA)-B*5701 in HIV-1-infected UK subjects. HIV Med. 2010 Mar;11(3):187-92. Epub 2009 Sep 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1569
Not Provided
Not Provided

Inclusion criteria:

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

Exclusion criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00453440
CNA109479
No
Not Provided
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, BSc MBBS GlaxoSmithKline
GlaxoSmithKline
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP