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临床试验/NCT00002369
NCT00002369已完成不适用

An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

Bristol-Myers Squibb11 个研究点 分布在 2 个国家目标入组 200 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
200
试验地点
11

研究概览

简要总结

To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

详细描述

100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).

Patients will be treated for 48 weeks.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients must have:
  • •Documented HIV infection.
  • •CD4 cell count of 200 - 700 cells/mm3.

排除标准

  • •Co-existing Condition:
  • •Patients with the following symptoms or conditions are excluded:
  • •AIDS defining condition within 1 month of study entry.
  • •Prior Medication:
  • •Patients with any history of antiretroviral therapy treatment.

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry

研究点 (11)

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