课题基金 / 基金详情

SAQUINAVIR SOFT GEL CAP TID IN COMBO W/ 2 NRTS VS SAQUINAVIR BID IN H

SAQUINAVIR SOFT GEL CAP TID IN COMBO W/ 2 NRTS VS SAQUINAVIR BID IN H
沙奎那韦软胶囊 TID 组合(含 2 个 NRTS)与沙奎那韦 BID H 的比较
批准号:
6265107
负责人:
L JOSEPH WHEAT
金额:
$0.04万
依托单位国家:
美国
项目类别:
财政年份:
1998
资助国家:
美国
项目状态:
已结题
起止时间:
1998-12-01 至 1999-11-30

项目摘要

项目成果

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中文摘要
翻译
一项随机、开放标签、多中心、IIIB期比较性24周研究,在初治和NRTI经验患者中治疗延长至48周。 根据基线病毒载量和既往抗逆转录病毒治疗对随机化进行分层。研究药物给药将持续24周。 患者将继续接受治疗至共同研究结束日期,直至48周治疗,并将根据评估时间表进行随访。 这项研究将于1997年7月开始,并将持续到每组招募275名患者为止,预计招募工作将于1997年10月完成,研究将于1998年11月完成。
英文摘要
A randomized, open-label, multicenter, Phase IIIB comparative 24 week study with a treatment extension to 48 weeks in treatment naive and NRTI experience patients. The randomization is stratified by baseline viral load and prior antiretroviral treatment. Study medications will be administered for 24 weeks. Patients will continue on treatment to a common study closure date to 48 weeks treatment and will be followed according to the Schedule of Assessments. The study will begin in July 1997 and will continue until 275 patients have been enrolled in each arm. Enrollment is expected to be completed by October 1997 and the study will be completed by November 1998.
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