Trial record 1 of 27 for:    " May 29, 2007":" June 29, 2007"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
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Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00481390
First received: May 31, 2007
Last updated: June 7, 2011
Last verified: June 2011
  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:


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
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:

  • None
  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, 2545 CH
GSK Investigational Site
Den Haag, Netherlands, 2512 VA
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

No publications provided

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

ClinicalTrials.gov processed this record on August 28, 2014