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

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00441688

Purpose

This study is a cross sectional observational study to evaluate the prevalence of HLA-B*5701 in the major French ethnotypes.

Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects previously tested for HLA-B*5701. Subjects will be approached during a standard clinic visit, and all subjects will be consented prior to any study specific procedure. Subjects will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by central and local methodologies.

Condition
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 HLAB*5701 in HIV-1 Infected Patients

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	2469
Study Start Date:	March 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, ART naive or experienced over the age of 18 years.
Patients must be either affiliated to or beneficiary of a social security category.
Patient is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441688

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD PhD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109477, PEPI
Study First Received:	February 28, 2007
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00441688
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by GlaxoSmithKline:

HLAgenetics polymorphism
Human Immunodeficiency virus

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:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009