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

May 31, 2007
June 7, 2011
June 2007
December 2007   (final data collection date for primary outcome measure)
Prevalence of HLA-B*5701 in European HIV-1 population [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00481390 on ClinicalTrials.gov Archive Site
Prevalence of HLA-B*5701 in major European ethnotypes [ Designated as safety issue: No ]
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Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

HIV-1 infected adults, out patients department

  • Infection, Human Immunodeficiency Virus I
  • HIV Infection
  • HIV-1 Infection
  • Procedure: Cheek cells sample
    Cheek cells sample
  • Procedure: Blood sample
    Blood sample
HIV-1 infected adults
HIV-1 infected adults
Interventions:
  • Procedure: Cheek cells sample
  • Procedure: Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1110
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Ireland,   Netherlands,   Portugal,   Switzerland
 
NCT00481390
CNA110329
Not Provided
E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP