NCT00002196已完成1 期
A Phase I Multiple Oral, Rising-Dose, Tolerance and Pharmacokinetic Trial of CI-1012 in HIV-1-Infected Volunteers.
Parke-Davis7 个研究点 分布在 1 个国家目标入组 32 人开始时间: 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
- 入组人数
- 32
- 试验地点
- 7
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give CI-1012 to HIV-infected patients who do not have any symptoms of the disease. This study also examines how the body handles CI-1012.
详细描述
Patients receive 2 weeks of oral CI-1012 therapy in this open-label study, with 8 patients entered at each dose level studied.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Serologic evidence of infection with HIV-
- •CD4+ cell count >= 200 cells/mm
- •HIV-1 RNA >= 10,000 copies/ml.
排除标准
- •Co-existing Condition:
- •Patients with the following conditions are excluded:
- •Viral, fungal, or bacterial infection requiring therapy other than topical medications.
- •Concurrent Medication:
- •Prophylactic systematic antibacterial, antifungal or antiviral agents.
- •Antiretroviral therapy. NOTE:
- •Patient must be willing to remain off antiretroviral therapy for 1 week after completing study medication.
- •Prior Medication:
- •Experimental therapy for >= 4 weeks prior to initiation of study medication.
- •Antiretroviral treatment for 3 weeks prior to initiation of study medication.
- •Systemic steroids or anticancer agents for 4 weeks prior to initiation of study medication.
研究者
研究点 (7)
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