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NCT00481390 Clinical Trial

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

HIV Infection Clinical Trial

Official title:
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00481390
Other study ID # CNA110329
Secondary ID
Status Completed
Phase N/A
First received May 31, 2007
Last updated June 7, 2011
Start date June 2007
Est. completion date December 2007

Study information
Verified date June 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Switzerland: SwissmedicNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 1110
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Cheek cells sample
Cheek cells sample
• Blood sample
Blood sample

Locations
Country Name City State
Finland GSK Investigational Site Helsinki
Ireland GSK Investigational Site Dublin
Netherlands GSK Investigational Site Alkmaar
Netherlands GSK Investigational Site Amsterdam
Netherlands GSK Investigational Site Arnhem
Netherlands GSK Investigational Site Den Haag
Netherlands GSK Investigational Site Den Haag
Netherlands GSK Investigational Site Enschede
Netherlands GSK Investigational Site Groningen
Netherlands GSK Investigational Site Maastricht
Netherlands GSK Investigational Site Rotterdam
Netherlands GSK Investigational Site Rotterdam
Portugal GSK Investigational Site Amadora
Portugal GSK Investigational Site Lisboa
Switzerland GSK Investigational Site Bern
Switzerland GSK Investigational Site La Chaux-de-Fonds
Switzerland GSK Investigational Site Lausanne
Switzerland GSK Investigational Site Lugano
Switzerland GSK Investigational Site Zuerich
Switzerland GSK Investigational Site Zürich

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Finland,  Ireland,  Netherlands,  Portugal,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of HLA-B*5701 in European HIV-1 population No
Secondary Prevalence of HLA-B*5701 in major European ethnotypes No
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