NCT00004580已完成1 期
Phase I/II Study of ABT-378/Ritonavir in Protease Inhibitor Experienced HIV-Infected Patients
Abbott10 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 10
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give ABT-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to HIV-infected patients who previously have taken protease inhibitors. This study also examines how the body handles this combination of anti-HIV drugs.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Concurrent Medication:
- •- Antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks.
- •Patients must have:
- •- HIV infection with plasma HIV RNA of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening.
- •Prior Medication:
- •Naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors.
排除标准
- •Concurrent Medication:
- •Medications that are contraindicated with ABT-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine.
- •Over-the-counter medicine or alcohol, without knowledge or permission of the investigator.
- •Patients with the following prior conditions are excluded:
- •Evidence of acute illness determined by vital signs, physical examination, or laboratory results.
- •Clinically significant abnormal ECG results.
- •Positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study.
- •Prior Medication:
- •Investigational drugs with the exception of Amprenavir within 28 days prior to the initiation of study dosing.
- •Treatment with a non-nucleoside reverse transcriptase inhibitor.
- •Treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen.
- •Treatment with more than one protease inhibitor concurrently.
- •Risk Behavior:
- •Active substance abuse, alcohol abuse, psychiatric illness.
- •Presumption, by investigator, of poor compliance to regimen.
研究者
研究点 (10)
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