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

September 9, 2017 updated by: ViiV Healthcare

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, WS2 9PS
        • GSK Investigational Site
      • London, United Kingdom, E1 1BB
        • GSK Investigational Site
      • London, United Kingdom, SE1 7EH
        • GSK Investigational Site
      • London, United Kingdom, SW17 0QT
        • GSK Investigational Site
      • London, United Kingdom, W2 1NY
        • GSK Investigational Site
      • London, United Kingdom, E9 6SR
        • GSK Investigational Site
    • London
      • Woolwich, London, London, United Kingdom, SE18 4QH
        • GSK Investigational Site
    • Warwickshire
      • Birmingham, Warwickshire, United Kingdom, B4 6DH
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of HLA-B*5701 in the UK population via central labs
Time Frame: 2 Hours
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 Outcome Measures

Outcome Measure
Time Frame
Prevalence of HLA-B*5701 in major UK ethnotypes in the study population.
Time Frame: 2 Hours
2 Hours
Description of HLA-B*5701 in the UK population via local labs.
Time Frame: 2 Hours
2 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 20, 2007

Primary Completion (ACTUAL)

August 10, 2007

Study Completion (ACTUAL)

August 10, 2007

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (ESTIMATE)

March 29, 2007

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2017

Last Update Submitted That Met QC Criteria

September 9, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNA109479

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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