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临床试验/EUCTR2020-006102-23-IT
EUCTR2020-006102-23-IT进行中(未招募)1 期

Study of a novel combination of immunovirologic and genetic parameters in early-treated HIV-1 patients undergone to antiretroviral therapy interruption (ATI) aimed at defining an algorithm predictive of post-treatment control (PCT) - ImmuneRaRe_RF-2019-12369708

OSPEDALE SAN RAFFAELE0 个研究点目标入组 100 人开始时间: 2021年6月7日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Male or female, aged 18-60 years
  • Confirmed HIV-1 seropositivedocumented
  • ARTcommenced duringprimary HIV infection, as defined by Fiebig stage
  • Plasma HIV-RNA <50 copies/ml for at least 24 months
  • CD4+ T cell count > 350 cells/mm3 at the last routine follow-up visit
  • No new AIDS-defining diagnosis or progression of HIV-related disease
  • Able to adhere to an effective ART regimen for the duration of the study
  • Willing and able to give written informed consent for participation in the study
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Confirmed HIV-2 seropositive
  • Women who are pregnant
  • History of systemic cancer, such as Kaposi’s sarcoma and lymphoma, or other virus-associated malignancies and/or history of AIDS-defining illness according to Centers for Disease Control and Prevention criteria
  • Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both active and chronic hepatitis C virus infection, with detectable virus RNA, and syphilis
  • Naso-pharyngeal swab positive for SARS-CoV-2

研究者

发起方
OSPEDALE SAN RAFFAELE

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