Prospective Epidemiological Study Of The Prevalence Of HLA-B*5701 In HIV-1 Infected Patients

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00481390

Collaborator

(none)

1,110

Enrollment

Locations

Duration (Months)

55.5

Patients Per Site

9.2

Patients Per Site Per Month

Study Details

Study Description

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-B5701. 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-B5701 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	Phase
Infection, Human Immunodeficiency Virus I HIV Infection HIV-1 Infection	Procedure: Cheek cells sample Procedure: Blood sample

Study Design

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 :

Jun 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
HIV-1 infected adults HIV-1 infected adults	Procedure: Cheek cells sample Cheek cells sample Procedure: Blood sample Blood sample

Arm

Intervention/Treatment

HIV-1 infected adults

Procedure: Cheek cells sample

Cheek cells sample

Procedure: Blood sample

Blood sample

Outcome Measures

Primary Outcome Measures

Prevalence of HLA-B*5701 in European HIV-1 population []

Secondary Outcome Measures

Prevalence of HLA-B*5701 in major European ethnotypes []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	GSK Investigational Site	Helsinki	Finland	00029
2	GSK Investigational Site	Dublin	Ireland	8
3	GSK Investigational Site	Alkmaar	Netherlands	1815 JD
4	GSK Investigational Site	Amsterdam	Netherlands	1105 AZ
5	GSK Investigational Site	Arnhem	Netherlands	6815 AD
6	GSK Investigational Site	Den Haag	Netherlands	2512 VA
7	GSK Investigational Site	Den Haag	Netherlands	2545 CH
8	GSK Investigational Site	Enschede	Netherlands	7511JX
9	GSK Investigational Site	Groningen	Netherlands	9713 GZ
10	GSK Investigational Site	Maastricht	Netherlands	6229 HX
11	GSK Investigational Site	Rotterdam	Netherlands	3015 GD
12	GSK Investigational Site	Rotterdam	Netherlands	3078 HT
13	GSK Investigational Site	Amadora	Portugal	2720-276
14	GSK Investigational Site	Lisboa	Portugal	1150
15	GSK Investigational Site	Bern	Switzerland	3010
16	GSK Investigational Site	La Chaux-de-Fonds	Switzerland	CH 2301
17	GSK Investigational Site	Lausanne	Switzerland	1011
18	GSK Investigational Site	Lugano	Switzerland	6900
19	GSK Investigational Site	Zuerich	Switzerland	8091
20	GSK Investigational Site	Zürich	Switzerland	8030