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
• 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

• Acquired Immunodeficiency Syndrome
• Communicable Diseases
• HIV Infection
• HIV Infections
• HIV-1 Infection
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus I

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