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

Phase 4

Completed

• Conditions: Infection, Human Immunodeficiency Virus
• Interventions: Drug: GI265235

• Registration Number: NCT00441688
• Lead Sponsor: ViiV Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Study Start: 2007-03-15
• Primary Completion: 2007-06-01
• Study Completion: 2007-06-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 974

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GI265235	GI265235	-

Primary Outcome Measures

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

Name	Time	Method
Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population	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	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.