Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication (CHEMOMAR)
Effect on HIV-1 cell reservoirs of the concomitant administration of intensive chemotherapy and the pharmacological blockade of CCR5 coreceptors: a pilot, open, randomized, and controlled clinical trial.
研究概览
研究类型
介入性
注册 (实际的)
7
阶段
- 第一阶段早期
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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Madrid、西班牙、28034
- Hospital Universitario Ramon Y Cajal
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Madrid、西班牙、28046
- Hospital Universitario La Paz
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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 65年 (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:
- Patients who give written consent to participate in the study
- Age between 18 and 65 years old, included.
- Chronic HIV-1 Demonstration of R5 viral tropism (use of CCR5 coreceptors) by genotyping in plasma samples stored
- Patients that are to be treated with intensive chemotherapy for non Hodgkin lymphoma With or without stable antiretroviral therapy
- Patients that are able to understand the purpose of the study and be available for scheduled appointments.
- Both in the case of female and male patients, the patient agrees to use a double barrier method of contraception from the moment of signing the informed consent until 3 months after the end of their participation in the study.
Exclusion Criteria:
- To have planned antiretroviral treatment interruption during the participation in the study
- Hypersensitivity to products used in this study
- To be involved in another clinical trial or received an investigational drug within 3 months prior to the study initiation
- To have contraindications or limitations to perform leukapheresis
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：随机化
- 介入模型：并行分配
- 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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无干预：Group 1 (Control)
Patients receiving intensive chemotherapy with/without stable antiretroviral therapy. Patients not receiving antiretroviral therapy will start it. Patients randomized to this group will not receive clinical trial treatment (neither Maraviroc or Placebo) |
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实验性的：Group 2 (Treatment)
Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc. Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc. |
Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery. Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours
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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number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
大体时间：Same as chemotherapy treatment (expected average of 6 months)
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Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
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Same as chemotherapy treatment (expected average of 6 months)
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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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Proviral DNA (copies/million cells)
大体时间：Same as chemotherapy treatment (expected average of 6 months)
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Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
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Same as chemotherapy treatment (expected average of 6 months)
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Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)
大体时间：Same as chemotherapy treatment (expected average of 6 months)
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Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
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Same as chemotherapy treatment (expected average of 6 months)
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Levels of HIV-1 antibodies
大体时间：Same as chemotherapy treatment (expected average of 6 months)
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Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
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Same as chemotherapy treatment (expected average of 6 months)
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Percentage of CD4+ and CD8+ cells with immune activation markers
大体时间：Same as chemotherapy treatment (expected average of 6 months)
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Secondary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
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Same as chemotherapy treatment (expected average of 6 months)
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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。
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。
一般刊物
- Chun TW, Stuyver L, Mizell SB, Ehler LA, Mican JA, Baseler M, Lloyd AL, Nowak MA, Fauci AS. Presence of an inducible HIV-1 latent reservoir during highly active antiretroviral therapy. Proc Natl Acad Sci U S A. 1997 Nov 25;94(24):13193-7. doi: 10.1073/pnas.94.24.13193.
- Finzi D, Hermankova M, Pierson T, Carruth LM, Buck C, Chaisson RE, Quinn TC, Chadwick K, Margolick J, Brookmeyer R, Gallant J, Markowitz M, Ho DD, Richman DD, Siliciano RF. Identification of a reservoir for HIV-1 in patients on highly active antiretroviral therapy. Science. 1997 Nov 14;278(5341):1295-300. doi: 10.1126/science.278.5341.1295.
- Wang C, Vlahov D, Galai N, Bareta J, Strathdee SA, Nelson KE, Sterling TR. Mortality in HIV-seropositive versus -seronegative persons in the era of highly active antiretroviral therapy: implications for when to initiate therapy. J Infect Dis. 2004 Sep 15;190(6):1046-54. doi: 10.1086/422848. Epub 2004 Aug 17.
- Moreno S, Mocroft A, Monforte Ad. Medical and societal consequences of late presentation. Antivir Ther. 2010;15 Suppl 1:9-15. doi: 10.3851/IMP1523.
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
2012年7月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2015年6月24日
首先提交符合 QC 标准的
2015年6月26日
首次发布 (估计)
2015年7月1日
研究记录更新
最后更新发布 (估计)
2015年12月18日
上次提交的符合 QC 标准的更新
2015年12月17日
最后验证
2015年12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.
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