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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00481390

Purpose

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.

Condition
HIV-1 Infection HIV Infection

MedlinePlus related topics: AIDS

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	1110
Study Start Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481390

Locations

Finland
GSK Investigational Site
Helsinki, Finland, 00029
Ireland
GSK Investigational Site
Dublin, Ireland, 8
Netherlands
GSK Investigational Site
ALKMAAR, Netherlands, 1815 JD
GSK Investigational Site
ROTTERDAM, Netherlands, 3078 HT
GSK Investigational Site
DEN HAAG, Netherlands, 2545 CH
GSK Investigational Site
GRONINGEN, Netherlands, 9713 GZ
GSK Investigational Site
ROTTERDAM, Netherlands, 3015 GD
GSK Investigational Site
ARNHEM, Netherlands, 6815 AD
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
ENSCHEDE, Netherlands, 7511JX
GSK Investigational Site
DEN HAAG, Netherlands, 2512 VA
GSK Investigational Site
AMSTERDAM, Netherlands, 1105 AZ
Portugal
GSK Investigational Site
Amadora, Portugal, 2720-276
GSK Investigational Site
Lisboa, Portugal, 1150
Switzerland
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
Lausanne, Switzerland, 1011
GSK Investigational Site
Zuerich, Switzerland, 8091
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Zürich, Switzerland, 8030

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CNA110329
Study First Received:	May 31, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00481390
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Switzerland: Swissmedic

Keywords provided by GlaxoSmithKline:

HLA-B*5701
prevalence
HIV
Treatment Experienced
Treatment Naive

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Slow Virus Diseases

Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 13, 2009