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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: HIV-1 Infection; HIV Infection; Infection, Human Immunodeficiency Virus I

Treatments: Procedure: Cheek cells sample; Procedure: Blood sample

Study type: Observational

Funder types: Industry

Identifiers

NCT00481390

CNA110329

Details and patient eligibility

About

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.

Enrollment: 1,110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,110 participants in 1 patient group

HIV-1 infected adults

Description:

HIV-1 infected adults

Treatment:

Procedure: Blood sample

Procedure: Cheek cells sample