Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
2014年1月13日 更新者：ViiV Healthcare
A Multicenter, Open Label Study Of Maraviroc, Zidovudine And Lamivudine Twice Daily For The Treatment Of Antiretroviral Naïve HIV-Infected Patients With R5 HIV-1 In Russia
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy.
The aim is to assess the efficacy and safety of this combination in a Russian population of patients.
研究概览
研究类型
介入性
注册 (实际的)
98
阶段
- 第四阶段
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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Krasnoyarsk、俄罗斯联邦、660049
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Moscow、俄罗斯联邦、105275
- Federal scientific and methodological center on AIDS prophylaxis and control
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Moscow、俄罗斯联邦、129110
- Moscow regional center on AIDS and infectious diseases prophylaxis and control
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Nizhnij Novgorod、俄罗斯联邦、603005
- Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg、俄罗斯联邦、190103
- Saint-Petersburg Center on AIDS and Infectious Diseases Prophylaxis and Control
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Saint-Petersburg、俄罗斯联邦、196645
- Federal State Institution Republican clinical infectious hospital of Roszdrav
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Smolensk、俄罗斯联邦、214006
- Smolensk Center on AIDS and infectious diseases prophylaxis and control
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Volgograd、俄罗斯联邦、400040
- Volgograd Regional Center on AIDS and Infectious Diseases Prophylaxis and Control
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Over 18 years of age.
- R5 HIV infection on screening tropism test.
- Viral load >1,000 copies/mL.
- Never previously treated with anti-HIV medicines.
Exclusion Criteria:
- Previously treated with anti-HIV medicines.
- Hepatitis B co-infection.
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
- 主要用途：治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Treatment
Single arm study of combivir and maraviroc for 48 weeks
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Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
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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Percentage of Participants With Plasma Human Immuno Deficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) Load <50 Copies/Milliliter (mL) at 48 Weeks.
大体时间：48 weeks
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Participants' responder status at Week 48 was assessed according to Missing, discontinuation= Failure (MDF) algorithm.
This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
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48 weeks
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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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Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load <50 Copies/mL at Post-baseline Visits.
大体时间：Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
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Participants' responder status at Week 48 was assessed according to MDF algorithm.
This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
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Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
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Virologic Response: Percentage of Participants With Plasma HIV-1 RNA Load < 400 Copies/mL at Post-baseline Visits.
大体时间：Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
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Participants' responder status at Week 48 was assessed according to MDF algorithm.
This algorithm treats all participants with HIV 1 RNA data missing at the time of interest or discontinuation of study drug as failures or non responders.
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Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 36 and Week 48
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Virologic Response: Rate of Virologic Failure at Week 48.
大体时间：48 weeks
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Virologic failure defined as: failure to achieve a reduction from baseline in HIV 1 RNA ≥ 0.5 log10 copies /mL by the second viral load determination (unless viral load was below the lower limit level of quantification [LLOQ]); or a ≥ 0.5 log10 increase from nadir in HIV 1 RNA after achieving a HIV 1 RNA reduction from BL >0.5 log10 copies/mL; or a HIV 1 RNA level of >1000 copies/mL after having achieved a HIV 1 RNA level below LLOQ.
Participants with Time to loss of virologic response (defined by level of <50 copies/mL) failure were classified as rebounders or non-responders.
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48 weeks
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Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
大体时间：Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+ cell count
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Week 48
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Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)
大体时间：Week 48
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Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD4+ cell count
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Week 48
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Immunological Response at Week 48: Absolute Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
大体时间：Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD8+ cell count.
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Week 48
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Immunological Response at Week 48: Percentage Change From Baseline in Absolute Cluster of Differentiation 8 (CD8)
大体时间：Week 48
|
Immunological Response was summarized using percentage change from Baseline to Week 48 in absolute CD8+ cell count.
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Week 48
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Immunological Response at Week 48: Change From Baseline in Absolute Cluster of Differentiation 4 (CD4)/ Cluster of Differentiation 8 (CD8) Ratio.
大体时间：Week 48
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Immunological Response was summarized using absolute change from Baseline to Week 48 in absolute CD4+/ CD8+ ratio.
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Week 48
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Number of Participants With Genotypic Resistance.
大体时间：Screening to Week 48 or Time of treatment Failure
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The viral genotypes were captured at Baseline and at treatment failure or Early termination and any resistance-associated mutations summarized descriptively at Week 48 for the Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNRTIs)drug classes.
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Screening to Week 48 or Time of treatment Failure
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Number of Participants With HIV-1 RNA Tropism Status Using Genotyping Assay at Screening and at the Time of Virologic Failure.
大体时间：Screening to Week 48 or Time of treatment Failure
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Change in tropism were summarized at the time of treatment failure or Early Termination (note: this was performed for participants with viral load > 400 copies/mL only).
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Screening to Week 48 or Time of treatment Failure
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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。
合作者
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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
2011年6月1日
初级完成 (实际的)
2012年10月1日
研究完成 (实际的)
2013年7月1日
研究注册日期
首次提交
2011年1月11日
首先提交符合 QC 标准的
2011年1月11日
首次发布 (估计)
2011年1月12日
研究记录更新
最后更新发布 (估计)
2014年3月3日
上次提交的符合 QC 标准的更新
2014年1月13日
最后验证
2014年1月1日
更多信息
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.