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Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1

Pilot Study Of The Effect Of A CCR5 Coreceptor Antagonist On The Latency And Reservoir Of HIV-1 In Patients Taking Highly Active Antiretroviral Therapy

The presence of a pool of cells latently infected by HIV-1 in patients taking HAART and with a viral load below 50 copies/mL is the main limitation to eradication of the virus from the body. This viral reservoir prevents antiretroviral therapy from being interrupted; therefore, patients are obliged to continue with treatment for a period calculated to be greater than 60 years.

Despite the important advances in knowledge of the biology of this reservoir, we still have no real knowledge about its dynamics. The opportunity to carry out a clinical trial for the first time with CCR5 coreceptor antagonists is exceptional, since the results could provide important information on the nature of this reservoir.

If maintenance of the reservoir is a dynamic process, inclusion of CCR5 inhibitors is expected to lead to a reduction in the size of this reservoir. This effect could be critical when including IAT (viral reactivation), since, in theory, it would be necessary to act on a smaller reservoir. Current consensus is that it would be necessary to act on almost 100% of the viral reservoir (approximately 1,000,000 cells).

The study has also been designed to enable us to understand the biochemical and molecular mechanisms by which certain drugs can induce viral reactivation in vitro as a previous step to a clinical trial aimed at reactivating viral latency and eradicating HIV-1 from the body.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

10

阶段

  • 阶段2

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

      • Madrid、西班牙、28034
        • Hospital Universitario Ramon y Cajal

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • After receiving information on the design and objectives of the study, the possible risks involved, and the fact that they can refuse to collaborate at any time, patients will give their informed consent to participate in the study and agree to provide material for the cellular and molecular studies.
  • Aged over 18 years.
  • Chronic HIV infection
  • Antiretroviral therapy with at least 3 drugs for at least 2 years and with no modifications expected during the study. Antiretroviral drugs can be switched due to intolerance as long as plasma viremia remains controlled.
  • Undetectable viral load determined by ultrasensitive techniques (<50 copies HIV RNA/mL) for at least 2 years.
  • CD4+ T lymphocyte count above 350 cells/mm3.
  • Demonstration of R5 viral tropism (use of CCR5 coreceptors) by phenotyping in plasma samples stored before antiretroviral therapy is started.
  • Understand the objective of the study and be available to make frequent visits to the hospital.

Exclusion Criteria:

  • Previous failure of antiretroviral therapy, understood as a rebound in viral load that can be detected after having reached undetectable levels. Low-grade increases (<200 copies of HIV RNA/mL) and transitory increases (blips) resolved without modifying antiretroviral therapy are excluded.
  • Proven resistance against the antiretroviral drugs under study.
  • Planned interruption of antiretroviral therapy.
  • Taking immunosuppressive or immunostimulating medication of any type, including valproic acid.
  • Taking a fusion inhibitor (enfuvirtide).
  • Pregnancy or intention to become pregnant during the study.

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:基础科学
  • 分配:不适用
  • 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
实验性的:Maraviroc
Adult patients with HIV infection and a viral load that has been suppressed for a long period (less than 50 copies/mL for at least 2 years) while on antiretroviral therapy.The treatment group will maintain the habitual antiretroviral therapy combined with maraviroc.
Maraviroc (INN), 300 mg tablets. A dose of 300 mg will be administered every 12 hours.
其他名称:
  • celsentri
  • CCR5 coreceptor antagonist

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Frequency of resting CD4+ T cells infected by a replicative virus
大体时间:18 months
18 months

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

调查人员

  • 首席研究员:Santiago Moreno Guillen, MD,PhD、Hospital Universitario Ramón y Cajal. Madrid

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

2008年3月1日

初级完成 (实际的)

2015年1月1日

研究完成 (实际的)

2015年1月1日

研究注册日期

首次提交

2008年11月10日

首先提交符合 QC 标准的

2008年11月20日

首次发布 (估计)

2008年11月21日

研究记录更新

最后更新发布 (估计)

2015年1月26日

上次提交的符合 QC 标准的更新

2015年1月23日

最后验证

2015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.

HIV-1的临床试验

maraviroc的临床试验

3
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