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

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	Intervention
Infection, Human Immunodeficiency Virus I HIV Infection HIV-1 Infection	Procedure: Cheek cells sample Procedure: Blood sample


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Prevalence of HLA-B*5701 in European HIV-1 population [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevalence of HLA-B*5701 in major European ethnotypes [ Designated as safety issue: No ]


Enrollment:	1110
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
HIV-1 infected adults HIV-1 infected adults	Procedure: Cheek cells sample Cheek cells sample Procedure: Blood sample Blood sample

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

HIV-1 infected adults, out patients department

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Arnhem, Netherlands, 6815 AD
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
GSK Investigational Site
Den Haag, Netherlands, 2545 CH
GSK Investigational Site
Enschede, Netherlands, 7511JX
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Rotterdam, Netherlands, 3078 HT
Portugal
GSK Investigational Site
Amadora, Portugal, 2720-276
GSK Investigational Site
Lisboa, Portugal, 1150
Switzerland
GSK Investigational Site
Bern, Switzerland, 3010
GSK Investigational Site
La Chaux-de-Fonds, Switzerland, CH 2301
GSK Investigational Site
Lausanne, Switzerland, 1011
GSK Investigational Site
Lugano, Switzerland, 6900
GSK Investigational Site
Zuerich, Switzerland, 8091
GSK Investigational Site
Zürich, Switzerland, 8030

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information


Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00481390 History of Changes
Other Study ID Numbers:	CNA110329
Study First Received:	May 31, 2007
Last Updated:	June 7, 2011
Health Authority:	Switzerland: Swissmedic Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:


HIV HLA-B*5701 prevalence Treatment Experienced Treatment Naive

Additional relevant MeSH terms:


Infection Communicable Diseases HIV Infections Immunologic Deficiency Syndromes Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections	RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Slow Virus Diseases

ClinicalTrials.gov processed this record on September 28, 2016