A 96-Week, Phase IV, Randomized, Double-Blind, Multicenter Study of the Safety and Efficacy of EPZICOM Versus TRUVADA Administered in Combination With KALETRA in Antiretroviral-Naive HIV-1 Infected Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
研究概览
简要总结
This study was designed to test the safety and effectiveness of EPZICOM(abacavir/lamivudine) and TRUVADA (emtricitabine/tenofovir) for the treatment of HIV infection when both are used in combination with KALETRA (lopinavir/ritonavir) over 96 weeks
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
- Double (Participant, Investigator)
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
ABC/3TC
The intervention is a regimen containing abacavir/lamivudine + tenofovir/emtricitabine placebo +lopinavir/ritonavir.
干预措施: abacavir/lamivudine (Drug)
TDF/FTC
The intervention is a regimen containing tenofovir/emtricitabine + abacavir/lamivudine placebo + lopinavir/ritonavir.
干预措施: emtricitabine/tenofovir (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 by Missing=Failure (M=F), Switched Included Analysis.
时间窗: Week 48
A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Week 48. The percentage of participants with HIV-1 RNA \<50 copies/mL were tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 copies/mL and \>=100,000 copies/mL).
次要结局
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48(Week 48)
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96(Week 96)
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL(Weeks 48 and 96)
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL(Weeks 48 and 96)
- Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96(Weeks 48 and 96)
- Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA <100,000 Copies/mL(Weeks 48 and 96)
- Percentage of Participants With HIV-1 RNA <400 Copies/mL at Weeks 48 and 96 in Participants With Baseline HIV-1 RNA >=100,000 Copies/mL(Weeks 48 and 96)
- Median Change From Baseline in HIV-1 RNA at Week 48 and 96(Weeks 48 and 96)
- Median Change From Baseline in CD4+ Cells at Weeks 48 and 96(Weeks 48 and 96)
- Number of Participants Who Meet the Protocol-defined Virologic Failure (PDVF) Criteria at Week 96(Baseline to Week 96)
- Number of Confirmed Virologic Failure Participants Who Had Treatment-emergent Genotypic Resistance Through 96 Weeks(Baseline and time of virologic failure (up to Week 96))
- Number of Confirmed Virologic Failure Participants at Week 96 With Genotypic Resistance to Lamivudine (3TC) and Emtricitabine (FTC) and Had Phenotypic Reduced Susceptibility(Baseline and time of virologic failure (up to Week 96))
- Number of Participants Who Reported a Suspected Abacavir Hypersensitivity Reaction (ABC HSR) Reaction or Proximal Renal Tubule Dysfunction(Baseline through 96 weeks)