Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

NCT ID: NCT00481390

Last Updated: 2011-06-08

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

1110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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This study is a cross-sectional observational study to evaluate the prevalence of HLA-B\*5701 in the European area and in major European ethnotypes.

Any HIV-1 infected patient will be eligible for this study including treatment naïve and experienced patients, as well as patients previously tested for HLA-B\*5701. Patients will be approached during a standard clinic visit, and will be consented prior to any study specific procedure. They will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B\*5701 status by local and central laboratories.

In selected sites patients may be asked to provide an additional blood sample. This sample will be used to develop and validate different methodologies for assessing HLA-B\*5701 status.

Detailed Description

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Conditions

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Infection, Human Immunodeficiency Virus I HIV Infection HIV-1 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV-1 infected adults

HIV-1 infected adults

Cheek cells sample

Intervention Type PROCEDURE

Cheek cells sample

Blood sample

Intervention Type PROCEDURE

Blood sample

Interventions

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Cheek cells sample

Cheek cells sample

Intervention Type PROCEDURE

Blood sample

Blood sample

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* HIV-1 infected patients over the age of 18 years
* Patient is willing and 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 lead

Responsible Party

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GSK Clinical Disclosure

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Dublin, , Ireland

Site Status

GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Arnhem, , Netherlands

Site Status

GSK Investigational Site

Enschede, , Netherlands

Site Status

GSK Investigational Site

Groningen, , Netherlands

Site Status

GSK Investigational Site

Maastricht, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Amadora, , Portugal

Site Status

GSK Investigational Site

Lisbon, , Portugal

Site Status

GSK Investigational Site

Bern, , Switzerland

Site Status

GSK Investigational Site

La Chaux-de-Fonds, , Switzerland

Site Status

GSK Investigational Site

Lausanne, , Switzerland

Site Status

GSK Investigational Site

Lugano, , Switzerland

Site Status

GSK Investigational Site

Zurich, , Switzerland

Site Status

GSK Investigational Site

Zurich, , Switzerland

Site Status

Countries

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Finland Ireland Netherlands Portugal Switzerland

Other Identifiers

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CNA110329

Identifier Type: -

Identifier Source: org_study_id

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