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临床试验/NCT01249560
NCT01249560撤回不适用

Impact of Raltegravir on the Viral Reservoirs

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
20
试验地点
1
主要终点
Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytaires and monocytaires.

时间窗: 3 months

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

次要结局

  • Measure the effect of Raltegravir ® on the intracellular reservoirs lymphocytes and monocytes.(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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