NCT00038636已完成3 期
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
Abbott7 个研究点 分布在 3 个国家目标入组 36 人开始时间: 2000年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 7
- 主要终点
- Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of a high dose of ABT-378/ritonavir
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
- •Are at least 18 years old
- •Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening
- •HIV RNA level > 1000 copies/mL
- •Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcriptase inhibitor and at least one nucleoside reverse transcriptase inhibitor
排除标准
- •Subject is pregnant or breast-feeding
- •Subject has received an investigational drug within 30 days prior to screening
- •Have a history of pancreatitis
- •History of intolerance to ritonavir
- •Abnormal laboratory tests at screening
结局指标
主要结局
Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
次要结局
未报告次要终点
研究者
研究点 (7)
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