NCT01605084撤回3 期
An Open-Label Phase 3B Study in HIV-Infected Individuals With Viremia on or After Their First-Line Non-Nucleoside Reverse Transcriptase Inhibitor or Integrase Inhibitor-Based Regimen and Starting a Second-Line Regimen Consisting of ATV/RTV or DRV/RTV With an Optimized NRTI Backbone
Bristol-Myers Squibb12 个研究点 分布在 1 个国家开始时间: 2012年6月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 12
- 主要终点
- Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
研究概览
简要总结
The purpose of this study is to determine the proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 in patients who failed their first line therapy containing a non-nucleoside reverse transcriptase inhibitor (NNRTI) or an integrase inhibitor
详细描述
Allocation: Randomization will be stratified
- ATV = Atazanavir
- DRV = Darunavir
- RTV = Ritonavir
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Atazanavir (Drug)
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Ritonavir (Drug)
Arm 1: ATV/RTV 300/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Optimized NRTI backbone (Drug)
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Darunavir (Drug)
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Ritonavir (Drug)
Arm 2: DRV/RTV 800/100 mg QD + optimized NRTI backbone
Experimental
干预措施: Optimized NRTI backbone (Drug)
结局指标
主要结局
Proportion of subjects with Human immunodeficiency virus 1 (HIV-1) Ribonucleic Acid (RNA) < 50 c/mL
时间窗: At Week 48
次要结局
- Change from baseline in CD4 cell count(Baseline (Week 0) and at week 48)
- Incidence rates of serious adverse event (SAEs) and adverse events (AEs) leading to discontinuation(up to week 48)
- Proportion of subjects with HIV-1 RNA < 50 c/mL(At week 24)
- Incidence rates of antiretroviral resistance measured by newly emergent genotypic substitutions and phenotypic resistance to study drugs for virologic failure(up to week 48)
- Proportion of subjects with HIV-1 RNA < 50 c/mL at Week 48 by baseline M184V presence or absence(Week 48)
研究者
研究点 (12)
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