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临床试验/NCT00435838
NCT00435838已完成不适用

A Retrospective, Multi-Centre Observational Study to Evaluate Disease Management and Adverse Events in Adult Subjects With HIV-1 Infection Who Were Withdrawn From CNA106030 Due to a Positive HLA-B*5701 Test Result

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2007年3月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1

研究概览

简要总结

This is a retrospective observational study which follows on from CNA106030 (a study evaluating whether prospective genetic screening for HLA-B*5701 can reduce the incidence of hypersensitivity reactions to abacavir). This study aims to collect data on approximately 35 subjects who withdrew from CNA106030 when found to be HLA-B*5701 positive. HIV disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected

研究设计

研究类型
Observational
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who have received notification not to receive abacavir in the CNA106030 study because of a positive HLA-B*5701 screen result, and were subsequently withdrawn from protocol CNA
  • Subjects willing and able to understand and provide written informed consent prior to participation in this study.
  • French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
  • Exclusion criteria:
  • Subjects who were not enrolled in the CNA106030 study
  • Subjects who are not HLA-B*5701 positive
  • Subjects who do not consent to being told their HLA-B*5701 status

排除标准

  • 未提供

研究者

申办方类型
Industry

研究点 (1)

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