NCT00481390

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,110 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Cheek cells sample	Cheek cells sample
PROCEDURE	Blood sample	Blood sample

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-06-01
• Last updated: 2011-06-08

Locations

20 sites across 5 countries: Finland, Ireland, Netherlands, Portugal, Switzerland