A Randomized Comparison of Virco®TYPE HIV-1 Testing Versus Expert Interpretation of Genotypic Results for Control of HIV-1 Replication
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 756
- 试验地点
- 2
- 主要终点
- Proportion of patients with viral load <1000 60days after HIV regimen change
研究概览
简要总结
The investigators seek to determine whether Virco®TYPE HIV-1 provides benefits equivalent to those provided by local expert review. The investigators propose that clinic patients of the Ruth M. Rothstein CORE Center who are having genotypic testing performed will be randomized in a 1:1 fashion to local expert review and to Virco®TYPE HIV-1. Results of either method will be shared with primary HIV care providers. Patient outcomes will be reviewed at a time point equal to or greater than 2 months and 6 months following the change in antiretroviral medications following the testing
详细描述
Patients having some documented genotypic HIV resistance but having more than one fully active medication will be randomized to either local review or algorithmic review by VircoType HIV-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV resistance testing that demonstrates resistance to at least one drug
- •Patients of the CORE Center, Chicago Illinois
排除标准
- •Wild type HIV on resistance testing or less than or equal to one active antiretroviral medication
结局指标
主要结局
Proportion of patients with viral load <1000 60days after HIV regimen change
时间窗: 60 days
Proportion of patients with viral load <1000 180 days after HIV regimen change
时间窗: 180 days
次要结局
- Proportion of patients whose regimen fails and who require repeat resistance testing at 180 and 360 days(180 and 360 days)
- Proportion of patients with undetectable viral load 180days after HIV regimen change(180 days)
- CD4 Cell count change in each arm at 60 and 180 days(60 and 180 days)
- Proportion of patients with undetectable viral load 60days after HIV regimen change(60 days)
- Comparison of number of active drugs predicted by each review method and number of actual active drugs prescribed(180 days)