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Impact of Raltegravir on the Viral Reservoirs

2010年11月29日 更新者:Centre Hospitalier Universitaire de Nice

The objective of the antiretroviral treatment is to inhibit the viral replication, estimated(appreciated) by the measure of the viral plasmatic load(responsibility). In this inhibition of the viral replication usually joins an immune reconstruction [ 1 ]. Nevertheless, a viro-immunological dissociation, i.e. an undetectable viral load(responsibility) and an absence of immune reconstruction, is regularly observed. It is now turned out that an undetectable viral load(responsibility) does not correspond to the total absence of viral replication and that it is possible to detect of the intracellular pro-viral DNA . Raltegravir ®, because of its mode of action(share) inhibiting the integration of the pro-viral DNA in the chromosomes of the infected cells(units) , could decrease the intracellular reservoir of monocyte-macrophages, improve the homeostasis, so optimizing the cooperation lymphocytes T - macrophages. Several experimental data suggest that the regression of the abnormalities of cellular interactions, and the rate of apoptose abnormally raised(abnormally brought up) by cells(units) T at the patients in viro-immunological dissociation, could be obtained .

This study aims at measuring the impact of Raltegravir ® on the viral reservoirs lymphocyte and monocyte, to quantify the expression of the molecules of costimulation, the source(spring) of intercellular interactions lymphocytes - monocytes, and to measure the rate of apoptose of the cells(units) T.

研究概览

地位

未知

详细说明

20 patients will be included and followed over a period of 12 months

Population of the essay

Criteria of inclusion:

Patients from 18 years to 60 years HIV + treated(handled):

  • Patients presenting an undetectable viral load(responsibility) for at least 6 months and no more than year, by the use of a tritherapy containing 2 NUC + 1 IP.
  • Patients presenting an immunosuppression "average" with a rate of T CD4 understood between 350 and 500 cells(units) by ml.
  • Patients known for a perfect observance.

Criteria of not inclusion:

  • Preliminary Use of an inhibitor of the integrase
  • Patients presenting an opportunist infection and\or an evolutionary cancer
  • Patients benefiting from a treatment by IL-2, interferon-alpha, steroids or the other medicines known to modify the immunity.
  • Pregnant Women

研究类型

观察性的

注册 (预期的)

20

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

    • Alpes Maritimes
      • Nice、Alpes Maritimes、法国、06200
        • Dellamonica

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 60年 (成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

hiv +

描述

Inclusion Criteria:

Patients from 18 years to 60 years HIV + treated(handled):

  • Patients presenting an undetectable viral load(responsibility) for at least 6 months and no more than year, by the use of a tritherapy containing 2 NUC + 1 IP.
  • Patients presenting an immunosuppression "average" with a rate of T CD4 understood between 350 and 500 cells(units) by ml.
  • Patients known for a perfect observance.
  • Exclusion Criteria:

Preliminary Use of an inhibitor of the integrase

  • Patients presenting an opportunist infection and\or an evolutionary cancer
  • Patients benefiting from a treatment by IL-2, interferon-alpha, steroids or the other medicines known to modify the immunity.
  • Pregnant Women

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
raltegravir

To illustrate the cause and effect relationship between the abnormalities of the distribution(casting) of the molecules of co-activation and the rate of apoptose, we compare also 2 groups: a first group of patients with a rate of apoptose normal ( n=10 ), and another group of patients having a rate of apoptose aggravated ( n=10 ).

20 eligible patients will receive their treatment to J1 and will be estimated for the residual concentration of the raltegravir ®, the antiretroviral activity, the tolerance and the observance at the treatments of the study in the visits of evaluation of M1, M2, M3, M6, M12, and / or in case of premature stop(ruling) of the try(essay). Every visit will give rise to a clinical evaluation of the patient. The arisen of unwanted events

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
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.
大体时间:3 months

OBJECTIVES

Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes

3 months

次要结果测量

结果测量
措施说明
大体时间
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes.
大体时间:3 months

Secondary objectives:

Measure the quality of the interactions lymphocytes - monocytes through the expression membranaires of the molecules of cotsimulation, the measure of proliferation, apoptose and cytokines produced via an in vitro stimulation CD3-CD28. A modulation of the cellular viral reservoirs could indeed underestimate the cellular death so schedule(program) that the profile cytokinique.

Measure the impact of Raltegravir ® at the patients presenting an undetectable viral load(responsibility) on sub-population T CD4 and T CD8.

3 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。

调查人员

  • 首席研究员:ROGER pierre marie, med、CHU Nice

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1月1日

初级完成 (预期的)

2011年1月1日

研究完成 (预期的)

2011年3月1日

研究注册日期

首次提交

2010年11月29日

首先提交符合 QC 标准的

2010年11月29日

首次发布 (估计)

2010年11月30日

研究记录更新

最后更新发布 (估计)

2010年11月30日

上次提交的符合 QC 标准的更新

2010年11月29日

最后验证

2009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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