NCT00234910已完成3 期
A Phase III, Open Label, Randomized, Comparative Study of the Antiviral Efficacy of ARV Therapy With Lopinavir/Ritonavir (LPV/r-Kaletra) in Combination With Tenofovir (TDF) Versus Standard of Care (Kaletra in Combination With 2 Nucleoside RTIs) in naïve-HIV-1 Positive Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Antiviral efficacy by HIV RNA
研究概览
简要总结
The purpose of this study is to obtain a preliminary assessment of the antiviral activity and tolerability of simplified Kaletra dual agent therapy as initial treatment for HIV infection, relative to a Kaletra three drug standard of care reference arm.
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 positive
- •>18 years of age
- •HIV RNA> 400 copies/mL
- •Any CD 4 cell count
- •Antiretroviral naïve
- •No acute illness
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
2 drug arm
干预措施: Tenofovir DF (Drug)
A
Experimental
2 drug arm
干预措施: lopinavir/ritonavir with 2 Nucleoside RTIs (Drug)
B
Active Comparator
3 drug arm, SOC
干预措施: lopinavir/ritonavir with 2 Nucleoside RTIs (Drug)
结局指标
主要结局
Antiviral efficacy by HIV RNA
时间窗: 72 wks
Incidence of adverse events
时间窗: 72 wks
次要结局
- Adherence and quality of life(72 wks)
研究者
研究点 (1)
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