Clinical trial NCT00481390: Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
Official title: Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
HIV-1 Infection
Keywords: HIV
HLA-B*5701
prevalence
Treatment Experienced
Treatment Naive
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 1110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-1 infected adults, out patients department

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of HLA-B*5701 in European HIV-1 population
Secondary outcomes:
measure: Prevalence of HLA-B*5701 in major European ethnotypes
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: GSK Investigational Site
city: Dublin
country: Ireland
facility: GSK Investigational Site
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Arnhem
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
country: Netherlands
facility: GSK Investigational Site
city: Amadora
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: Bern
country: Switzerland
facility: GSK Investigational Site
city: La Chaux-de-Fonds
country: Switzerland
facility: GSK Investigational Site
city: Lausanne
country: Switzerland
facility: GSK Investigational Site
city: Lugano
country: Switzerland
facility: GSK Investigational Site
city: Zuerich
country: Switzerland
facility: GSK Investigational Site
city: Zürich
country: Switzerland
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: