Effectiveness of Efavirenz-based Regimen in HIV-1-infected Patients With Nevirapine Hypersensitivity
2011年3月14日 更新者：Bamrasnaradura Infectious Diseases Institute
Comparison of Virological and Immunological Results of Efavirenz-based Regimen in HIV-infected Patients With or Without Allergic Reactions to Nevirapine
The primary objective of this study is to compare the effectiveness of EFV-based regimens in HIV-1-infected patients who; (1) were previously allergic to NVP and stopped all ARV simultaneously; (2) were previously allergic to NVP and continued the other NRTIs for a period of time, i.e. "staggered interruption"; and (3) started EFV-based regimens as an initial regimen (as controlled group).
研究概览
研究类型
观察性的
注册 (实际的)
559
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Nonthaburi、泰国、11000
- Bamrasnaradura Infectious Disease Institute
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
HIV-infected patients who started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
描述
Inclusion Criteria:
- age 18-70 years old
- documented HIV infection
- started EFV-based regimens between January 2002 and December 2008 at Bamrasnaradura Infectious Diseases Institute
Exclusion Criteria:
- previously received non-HAART regimens such as dual NRTIs regimen, AZT monotherapy with single-dose NVP in pregnancy patients
- previously received protease inhibitor-based regimen
- diseases or conditions that significantly affected either kidney or liver functions such as decompensated liver cirrhosis, ESRD
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Simultaneous interruption (Exposure gr)
stopped all drugs in NNRTI-based regimens simultaneously after allergic reactions to NVP-based regimens, and later started EFV-based regimens
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Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
其他名称：
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Naive (Control group)
HIV-1-infected patients who started EFV-based regimens as their initial ARV regimens.
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Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
其他名称：
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staggered interruption (exposure group)
after having allergic reactions to NVP-based regimens, stopped NNRTIs first, continued the other NRTIs for a period of time, i.e. "staggered interruption", and later started EFV-based regimens
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Efavienz: 600 mg, oral, every 24 hours, continued medication until the end of study.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Virological failure
大体时间：until end of study cohort
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Virological failure was defined as either (1) two consecutive results of plasma HIV-1 RNA >400 copies/ml or (2) plasma HIV-1 RNA >1,000 copies/ml with genotypic resistance assay revealed NRTI or NNRTI resistance-associated mutations
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until end of study cohort
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Virological suppression
大体时间：24 months
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Virological suppression was defined as having plasma HIV-1 RNA <50 copies/ml
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24 months
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Median increase from baseline of CD4 cell count
大体时间：24 months
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24 months
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Adverse events
大体时间：until end of cohort
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Adverse events were defined as either (1) having more than grade 3 according to DAID AE Grading Table, or (2) having clinical events that leaded to changed antiretroviral medications
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until end of cohort
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Clinical outcomes such as death, major opportunistic infections, immune recovery syndrome, non-AIDS events
大体时间：until end of cohort
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until end of cohort
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年1月1日
初级完成 (实际的)
2010年3月1日
研究完成 (实际的)
2010年3月1日
研究注册日期
首次提交
2010年1月7日
首先提交符合 QC 标准的
2010年1月7日
首次发布 (估计)
2010年1月8日
研究记录更新
最后更新发布 (估计)
2011年3月15日
上次提交的符合 QC 标准的更新
2011年3月14日
最后验证
2011年3月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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