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NCT00441688 Clinical Trial

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

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:
Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00441688
Other study ID # 109477
Secondary ID
Status Completed
Phase Phase 4
First received February 28, 2007
Last updated August 17, 2017
Start date March 15, 2007
Est. completion date June 1, 2007

Study information
Verified date August 2017
Source ViiV Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 974
Est. completion date June 1, 2007
Est. primary completion date June 1, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GI265235

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ViiV Healthcare GlaxoSmithKline

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Day 1
Secondary 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. Day 1
Secondary 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. Day 1
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