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: August 17, 2017
Last verified: August 2017
  Purpose

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.


Condition Intervention Phase
Infection, Human Immunodeficiency Virus Drug: GI265235 Phase 4

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by ViiV Healthcare:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 974
Actual Study Start Date: March 15, 2007
Study Completion Date: June 1, 2007
Primary Completion Date: June 1, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GI265235 Drug: GI265235

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441688

Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials ViiV Healthcare
  More Information

Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00441688     History of Changes
Other Study ID Numbers: 109477
Study First Received: February 28, 2007
Last Updated: August 17, 2017

Keywords provided by ViiV Healthcare:
Human Immunodeficiency virus
HLAgenetics polymorphism

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 22, 2017