Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00453440

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	Procedure: Cheek swab & blood test	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment
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: AIDS Allergy

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

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
London, United Kingdom, SE1 7EH
GSK Investigational Site
London, United Kingdom, W2 1NY
GSK Investigational Site
London, United Kingdom, E9 6SR
GSK Investigational Site
London, United Kingdom, EC1A 7BE
GSK Investigational Site
London, United Kingdom, SW17 0QT
GSK Investigational Site
Birmingham, United Kingdom, WS2 9PS
United Kingdom, London
GSK Investigational Site
Woolwich, London, London, United Kingdom, SE18 4QH

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, BSc MBBS

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CNA109479
Study First Received:	March 28, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00453440 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

HIV
HLA-B*5701
Abacavir hypersensitivity reaction

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Hypersensitivity
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Abacavir
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on September 10, 2009