This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00441688
First received: February 28, 2007
Last updated: July 27, 2017
Last verified: July 2017
February 28, 2007
July 27, 2017
March 15, 2007
June 1, 2007   (Final data collection date for primary outcome measure)
The prevalence of HLA-B*5701 in the French HIV-1 infected population assessed using centralised screening assay results. [ Time Frame: 12 weeks ]
Any French HIV-1 infected participant was eligible for this study including Antiretroviral Therapy (ART) treatment naïve and experienced participants irrespective abacavir experience, as well as participants previously tested for HLA-B*5701. 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.
Not Provided
Complete list of historical versions of study NCT00441688 on ClinicalTrials.gov Archive Site
  • The prevalence of HLA-B*5701 in the major French ethnotypes in the study population. [ Time Frame: 12 Weeks ]
    Any French HIV-1 infected participant was eligible for this study including ART treatment naïve and experienced participants irrespective abacavir experience, as well as participants previously tested for HLA-B*5701. 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.
  • The description of HLA-B*5701 screening results obtained with local laboratory. [ Time Frame: 12 Weeks ]
    Any French HIV-1 infected participant was eligible for this study including ART treatment naïve and experienced participants irrespective abacavir experience, as well as participants previously tested for HLA-B*5701. 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.
Not Provided
Not Provided
Not Provided
 
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
July 2017

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