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临床试验/NCT00002400
NCT00002400已完成不适用

An Open-Label Randomized Study of Delavirdine Mesylate (Rescriptor) in Combination With Zidovudine (Retrovir) and Two Doses of Indinavir (Crixivan) Versus Zidovudine, Lamivudine (Epivir), and Indinavir in HIV-1-Infected Individuals

Pharmacia and Upjohn2 个研究点 分布在 1 个国家目标入组 45 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
45
试验地点
2

研究概览

简要总结

The purpose of this study is to compare the safety and effectiveness of giving HIV-infected patients delavirdine (DLV) plus zidovudine (ZDV) plus 2 doses of indinavir (IDV) or ZDV plus IDV plus lamivudine (3TC). This study also examines how the body processes DLV when it is given in combination with other drugs.

详细描述

In this multicenter, open-label study, 45 HIV-1-positive patients receive either combination drug therapy with delavirdine (DLV), zidovudine (ZDV), and indinavir (IDV) or combination drug therapy with ZDV, lamivudine (3TC), and IDV. NOTE: Patients are treated for 24 weeks and may opt to continue on study for 24 additional weeks, if HIV-1 RNA is less than 5,000 copies/ml or at the investigator's discretion.

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

入选标准

  • Patients must have:
  • HIV-1 positive.
  • CD4 count above
  • HIV-1 RNA greater than 20,
  • Prior Medication:
  • Less than 1 month prior treatment with zidovudine.

排除标准

  • Prior Medication:
  • Prior 3TC, protease inhibitors, or non-nucleoside reverse transcriptase inhibitors.
  • Prior ZDV of greater than 1 month total duration.
  • Prior Treatment:
  • Lamivudine.
  • Protease inhibitors.
  • Non-nucleoside reverse transcriptase inhibitors.

研究者

发起方
Pharmacia and Upjohn
申办方类型
Industry

研究点 (2)

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