Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00481390
First received: May 31, 2007
Last updated: June 7, 2011
Last verified: June 2011
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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:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
U.S. FDA Resources
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
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 June 17, 2013