NCT02486510终止早期 1 期
Effect of Cytoreductive Chemotherapy and a CCR5 Coreceptor Antagonist on HIV-1 Eradication
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Group 2 (Treatment)
Experimental
Patients receiving intensive chemotherapy with/without stable antiretroviral therapy and Maraviroc.
Patients not receiving antiretroviral therapy will start this theraphy together with Maraviroc.
干预措施: Maraviroc (Drug)
结局指标
主要结局
number of resting memory CD4+ T cells latently infected with replicative HIV-1, expressed as IUPM
时间窗: Same as chemotherapy treatment (expected average of 6 months)
Primary outcome will be measured before, during and after chemotherapy treatment until patient has reached normal lymphocytes levels
次要结局
- Proviral DNA (copies/million cells)(Same as chemotherapy treatment (expected average of 6 months))
- Effector T cells producing HIV-1 specific gamma interferon (cells/mm3)(Same as chemotherapy treatment (expected average of 6 months))
- Levels of HIV-1 antibodies(Same as chemotherapy treatment (expected average of 6 months))
- Percentage of CD4+ and CD8+ cells with immune activation markers(Same as chemotherapy treatment (expected average of 6 months))
研究者
研究点 (2)
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