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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00441688
First Posted: March 1, 2007
Last Update Posted: October 12, 2017
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.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
February 28, 2007
March 1, 2007
October 12, 2017
March 15, 2007
June 1, 2007   (Final data collection date for primary outcome measure)
Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results [ Time Frame: Day 1 ]
Tissue sample (cheek cells and blood sample) were collected from the participants to assess HLA-B*5701 status using centralized screening assay in the centralized laboratory.The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of participants with available HLAB*5701 result multiplied by 100.
Not Provided
Complete list of historical versions of study NCT00441688 on ClinicalTrials.gov Archive Site
  • Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population [ Time Frame: Day 1 ]
    Participants attended a single visit where an assessment of the participant's demographic background (age, sex , mode of HIV transmission, ethnicity, country of origin and parental country of origin) was conducted, and tissue samples (buccal cells and blood sample) were collected to determine the presence of HLA-B*5701 genotype by both central and local laboratories using centralized screening assay. The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of subjects with available HLAB*5701 result multiplied by 100. Data is presented for the prevalence of HLA-B*5701 in all the ethnotypes.
  • Number of participants with positive HLA-B*5701 screening results obtained with local laboratory [ Time Frame: Day 1 ]
    Tissue sample (cheek cells and blood sample) were collected from the participants to assess HLA-B*5701 status using centralized screening assay in the local laboratory. The prevalence was calculated as the ratio of the number of participants with HLA-B*5701 positive divided by the total number of subjects with available HLAB*5701 result. According to local laboratory, participants with positive results have been summarized here.
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Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients
Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients

This study is a cross sectional observational study to evaluate the prevalence of HLA-B*5701 in the major French ethnotypes.

Any HIV-1 infected subject will be eligible for this study including antiretroviral therapy (ART) naÃ-ve and experienced subjects irrespective of abacavir use, as well as subjects previously tested for HLA-B*5701. Subjects will be approached during a standard clinic visit, and all subjects will be consented prior to any study specific procedure. Subjects will be asked to provide a tissue sample (cheek cells and blood sample) which will be used to assess HLA-B*5701 status by central and local methodologies.

Not Provided
Interventional
Phase 4
Masking: None (Open Label)
Primary Purpose: Other
Infection, Human Immunodeficiency Virus
Drug: GI265235
Experimental: GI265235
Intervention: Drug: GI265235
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
974
June 1, 2007
June 1, 2007   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • HIV-1 infected patients, ART naive or experienced over the age of 18 years.
  • Patients must be either affiliated to or beneficiary of a social security category.
  • Patient is willing and able to understand and provide written informed consent prior to participation in this study.

Exclusion criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
France
 
NCT00441688
109477
No
Not Provided
Not Provided
ViiV Healthcare
ViiV Healthcare
GlaxoSmithKline
Study Director: GSK Clinical Trials ViiV Healthcare
ViiV Healthcare
August 2017

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