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

Completed

• Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection; HIV-1 Infection
• Interventions: Procedure: Cheek cells sample; Procedure: Blood sample

• Registration Number: NCT00481390
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-05-31
• Study First Submitted QC: 2007-05-31
• Study Start: 2007-06
• Study First Posted: 2007-06-01
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-1 infected adults	Cheek cells sample	HIV-1 infected adults
HIV-1 infected adults	Blood sample	HIV-1 infected adults

Primary Outcome Measures

Name	Time	Method
Prevalence of HLA-B*5701 in European HIV-1 population

Secondary Outcome Measures

Name	Time	Method
Prevalence of HLA-B*5701 in major European ethnotypes

Trial Locations

Locations (1)

GSK Investigational Site; 🇨🇭 Zürich, Switzerland