Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
1 other identifier
observational
1,110
5 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Shorter than P25 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2007
CompletedFirst Posted
Study publicly available on registry
June 1, 2007
CompletedStudy Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 8, 2011
June 1, 2011
6 months
May 31, 2007
June 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of HLA-B*5701 in European HIV-1 population
Secondary Outcomes (1)
Prevalence of HLA-B*5701 in major European ethnotypes
Study Arms (1)
HIV-1 infected adults
HIV-1 infected adults
Interventions
Eligibility Criteria
HIV-1 infected adults, out patients department
You may qualify if:
- HIV-1 infected patients over the age of 18 years
- Patient is willing and able to understand and provide written informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (20)
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Dublin, 8, Ireland
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Amsterdam, 1105 AZ, Netherlands
GSK Investigational Site
Arnhem, 6815 AD, Netherlands
GSK Investigational Site
Enschede, 7511JX, Netherlands
GSK Investigational Site
Groningen, 9713 GZ, Netherlands
GSK Investigational Site
Maastricht, 6229 HX, Netherlands
GSK Investigational Site
Rotterdam, 3015 GD, Netherlands
GSK Investigational Site
Rotterdam, 3078 HT, Netherlands
GSK Investigational Site
The Hague, 2512 VA, Netherlands
GSK Investigational Site
The Hague, 2545 CH, Netherlands
GSK Investigational Site
Amadora, 2720-276, Portugal
GSK Investigational Site
Lisbon, 1150, Portugal
GSK Investigational Site
Bern, 3010, Switzerland
GSK Investigational Site
La Chaux-de-Fonds, CH 2301, Switzerland
GSK Investigational Site
Lausanne, 1011, Switzerland
GSK Investigational Site
Lugano, 6900, Switzerland
GSK Investigational Site
Zurich, 8030, Switzerland
GSK Investigational Site
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 31, 2007
First Posted
June 1, 2007
Study Start
June 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
June 8, 2011
Record last verified: 2011-06