search
Back to results

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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
Cheek swab & blood test
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Infection, Human Immunodeficiency Virus focused on measuring HIV, HLA-B*5701, Abacavir hypersensitivity reaction, HIV Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  • None

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

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.

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.

Full Information

First Posted
March 28, 2007
Last Updated
September 9, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00453440
Brief Title
Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701
Official Title
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected UK Patients
Study Type
Observational

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 20, 2007 (Actual)
Primary Completion Date
August 10, 2007 (Actual)
Study Completion Date
August 10, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
Keywords
HIV, HLA-B*5701, Abacavir hypersensitivity reaction, HIV Infection

7. Study Design

Enrollment
1502 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Cheek swab & blood test
Intervention Description
Cheek swab & blood test
Primary Outcome Measure Information:
Title
Prevalence of HLA-B*5701 in the UK population via central labs
Description
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.
Time Frame
2 Hours
Secondary Outcome Measure Information:
Title
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
Time Frame
2 Hours
Title
Description of HLA-B*5701 in the UK population via local labs.
Time Frame
2 Hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Woolwich, London
State/Province
London
ZIP/Postal Code
SE18 4QH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Warwickshire
ZIP/Postal Code
B4 6DH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Birmingham
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19780860
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs