NCT00002401已完成不适用
An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
Pharmacia and Upjohn2 个研究点 分布在 1 个国家目标入组 160 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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).
详细描述
In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:
Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.
- Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior Medication:
- •Less than 1 month prior treatment with zidovudine.
排除标准
- •Prior Medication:
- •Prior indinavir.
- •Prior lamivudine.
- •Prior protease inhibitors.
- •Prior non-nucleoside reverse transcriptase inhibitors.
- •1 month or more prior zidovudine.
- •1. HIV-1 positive.
- •CD4 coun tis above
- •HIV-1 RNA levels greater than 20,000.
研究者
研究点 (2)
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