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临床试验/NCT03117985
NCT03117985终止不适用

Tracking and Exploring the Source of Viral REbound

Centre Hospitalier Régional d'Orléans1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2017年2月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
1
主要终点
Genetic Cartography

研究概览

简要总结

Phylogenic analysis of viruses hosted in marker positive reservoir cells including CD32a+ CD4 T lymphocytes and rebounding viruses after treatment interruption

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •- Age>18year old
  • •Nadir CD4>200/mm3
  • •CD4/CD8 ratio> 0.5
  • •Continuous antiretroviral therapy for more than 2 years
  • •Plasma Human Immunodeficiency Virus (HIV) 1 Ribonucleic acid (RNA) <50 copies/ml in the last 2 years
  • •Viral Load (VL)<20copies at inclusion
  • •Patients who are willing to participate and who understand the trial (particularly, the obligation to have protected intercourse during the study).
  • •Informed consent
  • •Short half-life treatment
  • •Health insurance
  • •A subset of CD4 (T4cells) express CD32a.

排除标准

  • •- Acquired Immune Deficiency Syndom (AIDS)
  • •Pregnancy
  • •Human immunodeficiency virus (HIV)-2 co infection
  • •Thrombopenia
  • •Neurological events during primary infection
  • •Hepatitis B + (HBV+)
  • •Hepatitis C + (HCV+)
  • •Cancer during the last 5 years.
  • •Life expectancy < 12 months
  • •Autoimmunity
  • •Acute infectious disease in the last 60 days.
  • •Hemoglobin<7g/dl
  • •Glomerular filtration < 60ml/min
  • •Refusing protected intercourse
  • •Risk of HIV transmission
  • •Psychiatric disorders.
  • •Alcool and drug abuse
  • •Involvement in another clinical trial evaluating a therapeutic.
  • •Being under tutorship
  • •Being deprived of liberty

研究组 & 干预措施

Antiretroviral therapy

Experimental

Stopping antiretroviral therapy

干预措施: no drug (Other)

结局指标

主要结局

Genetic Cartography

时间窗: Week 12

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 1

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 2

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 3

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 4

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 5

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 6

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 8

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

Genetic Cartography

时间窗: Week 10

Measuring the genetic distance between viruses contained in marker positive reservoir cells including CD32a+ CD4 T (T4cells) lymphocytes and viruses rebounding after treatment interruption. This cartography will be made when Plasma Human Immunodeficiency Virus -1 ribonucleic acid (RNA) superior or equal to 1000 copies/ml

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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