Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00481390 |
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Recruitment Status :
Completed
First Posted : June 1, 2007
Last Update Posted : June 8, 2011
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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 or disease | Intervention/treatment |
|---|---|
| Infection, Human Immunodeficiency Virus I HIV Infection HIV-1 Infection | Procedure: Cheek cells sample Procedure: Blood sample |
| Study Type : | Observational |
| Actual Enrollment : | 1110 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective Epidemiological Study of the Prevalence of HLA-B*5701 in HIV-1 Infected Patients |
| Study Start Date : | June 2007 |
| Actual Primary Completion Date : | December 2007 |
| Actual Study Completion Date : | December 2007 |
| Group/Cohort | Intervention/treatment |
|---|---|
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HIV-1 infected adults
HIV-1 infected adults
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Procedure: Cheek cells sample
Cheek cells sample Procedure: Blood sample Blood sample |
- Prevalence of HLA-B*5701 in European HIV-1 population
- Prevalence of HLA-B*5701 in major European ethnotypes
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481390
| 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 | |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
| Responsible Party: | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00481390 History of Changes |
| Other Study ID Numbers: |
CNA110329 |
| First Posted: | June 1, 2007 Key Record Dates |
| Last Update Posted: | June 8, 2011 |
| Last Verified: | June 2011 |
Keywords provided by GlaxoSmithKline:
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HIV HLA-B*5701 prevalence Treatment Experienced Treatment Naive |
Additional relevant MeSH terms:
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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 |