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临床试验/NCT01038401
NCT01038401已完成不适用

Characterization of the Residual Replication of HIV-1 in the Gut-associated Lymphoid Tissue in Patients Receiving Effective Highly Active Antiretroviral Therapy: the ANRS EP 44 Study

French National Agency for Research on AIDS and Viral Hepatitis1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.

研究概览

简要总结

HIV-1 cannot be eradicated from infected individuals by current antiretroviral regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication. This project aims to characterize the residual replication of HIV-1 in subjects on antiretroviral therapy, particularly in the gut-associated lymphoid tissue.

详细描述

Highly active antiretroviral therapy (HAART) successfully controls HIV-1 replication in most individuals, resulting in substantial immune restoration and decreased morbidity and mortality. However HIV-1 cannot be eradicated from infected individuals by current regimens. Cellular reservoirs and tissue sanctuary sites allow latent HIV-1 persistence and ongoing low-level virus replication, despite maximum virus suppression on HAART. This project aims to characterize the residual replication of HIV-1 in subjects on HAART, particularly in the gut-associated lymphoid tissue (GALT). A group of 20 HIV-1-infected patients on effective HAART will undergo GI endoscopy and GALT biopsies will be taken. A sample of venous blood will also be collected. These samples will be use to characterize the residual viral populations on effective HAART in three compartments, plasma, monocytes, and GALT. HIV-1 coreceptor usage and its evolution on HAART will be characterized in virus reservoirs. This project could provide further insights into the residual replication of HIV-1 in subjects receiving HAART.

研究设计

研究类型
Interventional
分配方式
Non 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

入选标准

  • HIV-1 infection (ELISA and western-blot tests)
  • Continuous antiretroviral therapy >= 12 months
  • Plasma HIV-1 RNA =< 40 copies/ml >= 6 months
  • Indication of gastro-intestinal endoscopy
  • Age >= 18-year old
  • Physical examination
  • Informed consent

排除标准

  • Plasma HIV-1 RNA > 40 copies/ml in the last 6 months
  • Involvement in a HIV vaccine study
  • Treatment with interferon-alpha or PEG- interferon-alpha in the last 6 months
  • Treatment with interleukin-2 in the last 6 months
  • Decompensated cirrhosis
  • Abnormal hemostasis tests
  • Inflammatory bowel disease ; coeliac disease
  • Blood transfusion in the last 6 months
  • Absence of social security (health insurance)
  • Pregnant or breastfeeding woman
  • Incapable adult

结局指标

主要结局

Correlation between HIV-1 viral load and CD4+ T lymphopenia in the GALT.

次要结局

  • HIV-1 DNA load in the GALT vs blood CD4+ T cells
  • HIV-1 tropism in the GALT vs blood CD4+ T cells
  • Characterization of residual HIV-1 in the plasma < 40 copies/ml
  • Characterization of HIV-1 DNA in blood monocytes

研究者

发起方
French National Agency for Research on AIDS and Viral Hepatitis
申办方类型
Other Gov

研究点 (1)

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