NCT00038532已完成2 期
An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
Abbott54 个研究点 分布在 10 个国家目标入组 24 人开始时间: 2001年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 54
- 主要终点
- Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
研究概览
简要总结
The purpose of this study is to study amprenavir/ritonavir, saquinavir/ritonavir or efavirenz in HIV-infected patients following failure with Kaletra (ABT-378/ritonavir) as their first protease inhibitor based HAART.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Remain on present anti-HIV drugs during screening until a new regimen is started.
- •Have a viral load of at least 1,000 copies/ml on the 2 most recent tests after at least 24 weeks of lopinavir/ritonavir and while still on it.
- •Have an HIV which shows reduced susceptibility to lopinavir.
- •Are at least 18 years old.
- •Are not presently ill.
- •Have not been treated for an opportunistic infection within 30 days of screening.
- •Agree not to take certain drugs and agree to inform and get permission from the doctor before taking any medicines, over the counter medicines, herbal medicines, alcohol or recreational drugs.
- •Agree to use an accepted barrier method of birth control.
排除标准
- •Female subject is pregnant or lactating.
- •Have taken any protease inhibitor other than lopinavir/ritonavir for more that two weeks.
- •Are taking chemotherapy.
- •Have a medical problem with their pancreas.
- •Have been screened for this study within the past 12 weeks.
- •Appear to be unsuitable in the opinion of the doctor.
结局指标
主要结局
Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
次要结局
未报告次要终点
研究者
研究点 (54)
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