NCT00038519已完成2 期
An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra (Lopinavir/Ritonavir) as Their Second Protease Inhibitor.
Abbott52 个研究点 分布在 9 个国家目标入组 16 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
- 16
- 试验地点
- 52
- 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 the safety and efficacy of Amprenavir/ritonavir or saquinavir/ritonavir in HIV infected patients that have failed Kaletra as their second 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
- •Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated.
- •Subject demonstrates reduced susceptibility to lopinavir.
- •Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still on Kaletra therapy must be at least 1,000 copies/mL.
- •The Kaletra regimen must be the subject's second PI containing regimen and must not contain any other PIs.
- •Subject is at least 18 years of age.
- •Subject has not been treated for an active opportunistic infection within 30 days of screening.
排除标准
- •Subject has a history of active substance abuse or psychiatric illness that could preclude compliance to the protocol.
- •Female subject pregnant or lactating.
- •Use of an Investigational drug within 30 days prior to the initiation of drug dosing.
- •Subject is receiving systemic chemotherapy.
- •Subject has a history of acute or chronic pancreatitis.
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 (52)
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