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

Primary Purpose

Infection, Human Immunodeficiency Virus

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
GI265235
Sponsored by
ViiV Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Human Immunodeficiency Virus focused on measuring Human Immunodeficiency virus, HLAgenetics polymorphism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    GI265235

    Arm Description

    Outcomes

    Primary Outcome Measures

    Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results
    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
    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
    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.

    Full Information

    First Posted
    February 28, 2007
    Last Updated
    August 17, 2017
    Sponsor
    ViiV Healthcare
    Collaborators
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00441688
    Brief Title
    Prospective Epidemiological Study Of The Prevalence Of HLAB*5701 In HIV-1 Infected Patients
    Official Title
    Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 15, 2007 (Actual)
    Primary Completion Date
    June 1, 2007 (Actual)
    Study Completion Date
    June 1, 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ViiV Healthcare
    Collaborators
    GlaxoSmithKline

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Human Immunodeficiency Virus
    Keywords
    Human Immunodeficiency virus, HLAgenetics polymorphism

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Masking
    None (Open Label)
    Enrollment
    974 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GI265235
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    GI265235
    Primary Outcome Measure Information:
    Title
    Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results
    Description
    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.
    Time Frame
    Day 1
    Secondary Outcome Measure Information:
    Title
    Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population
    Description
    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.
    Time Frame
    Day 1
    Title
    Number of participants with positive HLA-B*5701 screening results obtained with local laboratory
    Description
    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.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    ViiV Healthcare
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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