NCT01620944终止3 期
A 48-Week, Randomized, Open-Label Phase 3B Study Comparing the Antiviral Efficacy and Safety of ATV/RTV 3TC With ATV/RTV Plus TDF/FTC In HIV-1-Infected, Treatment-Naïve Subjects, Followed By a 48-Week Period on ATV/RTV Plus 3TC
Bristol-Myers Squibb0 个研究点目标入组 3 人开始时间: 2012年7月31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
- 终止
- 发起方
- 入组人数
- 3
- 主要终点
- Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
研究概览
简要总结
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug [Lamivudine (3TC) 300 mg daily] or 2 additional drugs [Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily].
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
Arm1: ATV/RTVHS+3TC
Experimental
干预措施: Atazanavir (Drug)
Arm1: ATV/RTVHS+3TC
Experimental
干预措施: Ritonavir (Drug)
Arm1: ATV/RTVHS+3TC
Experimental
干预措施: Lamivudine (Drug)
Arm2: ATV/RTVHS+TDF/FTC
Active Comparator
干预措施: Atazanavir (Drug)
Arm2: ATV/RTVHS+TDF/FTC
Active Comparator
干预措施: Ritonavir (Drug)
Arm2: ATV/RTVHS+TDF/FTC
Active Comparator
干预措施: Tenofovir/Emtricitabine (Drug)
结局指标
主要结局
Proportion of Participants With HIV-1 RNA < 40 c/mL at Week 48
时间窗: Week 48
Proportion of subjects with HIV-1 RNA \< 40 c/mL at Week 48.
次要结局
- Incidence of Adverse Events Through Weeks 48 and 96(through weeks 48 and 96)
- Proportion of Participants With HIV-1 RNA < 40 c/mL and < 400 c/mL at Week 96(Week 96)
- Proportion of Participants With HIV-1 RNA < 400 c/mL at Week 48(Week 48)
- Incidence of Newly Emergent Genotypic Substitutions and Phenotypic Resistance to Study Drugs for Virologic Failures Through Week 48 and 96(Through week 48 and 96)
- Percent Change From Baseline in eGFR and Bone Mineral Density at Weeks 48 and 96(Weeks 48 and 96)
研究者
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