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

NCT ID: NCT00453440

Last Updated: 2017-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1502 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-20

Study Completion Date

2007-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus

Interventions

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Cheek swab & blood test

Cheek swab \& blood test

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

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GSK Investigational Site

Woolwich, London, London, United Kingdom

Site Status

GSK Investigational Site

Birmingham, Warwickshire, United Kingdom

Site Status

GSK Investigational Site

Birmingham, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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. doi: 10.1111/j.1468-1293.2009.00762.x. Epub 2009 Sep 24.

Reference Type DERIVED
PMID: 19780860 (View on PubMed)

Other Identifiers

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CNA109479

Identifier Type: -

Identifier Source: org_study_id

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