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临床试验/NCT00002447
NCT00002447已完成3 期

An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients

Hoffmann-La Roche49 个研究点 分布在 3 个国家目标入组 146 人开始时间: 1999年10月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
146
试验地点
49

研究概览

简要总结

The purpose of this study is to compare 2 anti-HIV drug combinations.

详细描述

Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks.

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 may be eligible for this study if they:
  • Are HIV-positive.
  • Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm
  • Are at least
  • Are able to complete the study.

排除标准

  • Patients will not be eligible for this study if they:
  • Have taken any anti-HIV medications for more than 2 weeks.
  • Are pregnant or breast-feeding.

研究者

申办方类型
Industry

研究点 (49)

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