NCT00262717已完成不适用
A Randomised Comparator Study to Assess the Relative Efficacy of Genotypic Versus Virtual Phenotypic Resistance Tests in Treatment Experienced Patients With HIV Infection for Whom a Change in Therapy is Indicated
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 19
- 主要终点
- The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
研究概览
简要总结
To compare two commercially available platforms for assessment of HIV drug resistance to determine which provides superior virological results.
We hypothesise that one test will be significantly superior to the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •HIV infected patients taking combination antiretroviral therapy, with plasma HIV RNA> 2000copies/mL, who were willing to change ARVs and who provided informed consent.
排除标准
- •Patients who were ARV naïve, who were experiencing an acute illness or judged to be unable to comply with the protocol requirements.
研究组 & 干预措施
Group A: subjects assign to receive a GENOTYPE
Experimental
randomised prior to the selection of their new cART regimen
干预措施: Blood test: genotype testing (Diagnostic Test)
Group B: subjects assign to receive a VIRTUAL PHENOTYPE
Experimental
randomised prior to the selection of their new cART regimen
干预措施: Blood test: genotype testing (Diagnostic Test)
结局指标
主要结局
The comparison between randomly assigned study arms in the mean area under the curve plasma HIV RNA at 48 weeks.
时间窗: at 48 weeks follow-up
次要结局
- Proportion of patients with undetectable plasma HIV RNA, Changes in CD4+ cell count, use of resistance test result in selecting new ART regimen(at 48 weeks)
研究者
研究点 (19)
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