Prospective Epidemiological Study of the Prevalence of HLAB*5701 in HIV-1 Infected Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 974
- 主要终点
- Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GI265235
干预措施: GI265235 (Drug)
结局指标
主要结局
Percentage of participants with HLA-B*5701 in the French HIV-1 infected population assessed using centralized screening assay results
时间窗: 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.
次要结局
- Percentage of participants with HLA-B*5701 in the major French ethnotypes in the study population(Day 1)
- Number of participants with positive HLA-B*5701 screening results obtained with local laboratory(Day 1)