Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701
1 other identifier
observational
1,502
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2007
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2007
CompletedFirst Submitted
Initial submission to the registry
March 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2007
CompletedSeptember 12, 2017
September 1, 2017
5 months
March 28, 2007
September 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of HLA-B*5701 in the UK population via central labs
The widespread of HLA-B\*5701 applied in the selected area in each participant of the UK population was tested via central labs. The result is summarized here.
2 Hours
Secondary Outcomes (2)
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
2 Hours
Description of HLA-B*5701 in the UK population via local labs.
2 Hours
Interventions
Cheek swab \& blood test
Eligibility Criteria
You may qualify if:
- HIV-1 infected patients over 18 years of age
- Patient willing \& able to understand and provide written informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (8)
GSK Investigational Site
Woolwich, London, London, SE18 4QH, United Kingdom
GSK Investigational Site
Birmingham, Warwickshire, B4 6DH, United Kingdom
GSK Investigational Site
Birmingham, WS2 9PS, United Kingdom
GSK Investigational Site
London, E1 1BB, United Kingdom
GSK Investigational Site
London, E9 6SR, United Kingdom
GSK Investigational Site
London, SE1 7EH, United Kingdom
GSK Investigational Site
London, SW17 0QT, United Kingdom
GSK Investigational Site
London, W2 1NY, United Kingdom
Related Publications (1)
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.
PMID: 19780860DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- observational
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2007
First Posted
March 29, 2007
Study Start
March 20, 2007
Primary Completion
August 10, 2007
Study Completion
August 10, 2007
Last Updated
September 12, 2017
Record last verified: 2017-09