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临床试验/NCT03980691
NCT03980691已完成1 期

Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir

Guangzhou 8th People's Hospital1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
4
试验地点
1
主要终点
Incidence of treatment-associated adverse events

研究概览

简要总结

To study the safety and effectiveness of the combination of Chidamide with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy on HIV patients based on cART.

详细描述

Despite the advent of combined antiretroviral therapy (cART), the persistence of viral reservoirs remains a major barrier to cure human immunodeficiency virus type 1 (HIV-1) infection. Recently, the shock and kill strategy, by which such reservoirs are eradicated following reactivation of latent HIV-1 by latency-reversing agents (LRAs), has been extensively practiced. It is important to reestablish virus-specific and reliable immune surveillance to eradicate the reactivated virus-harboring cells. Some studies have shown that Chidamide can highly activate the HIV reservoirs. The VC-CAR-T cells effectively induced the cytolysis of LRA-reactivated HIV-1-infected CD4 T lymphocytes isolated from infected individuals receiving suppressive cART. Our previous study demonstrated that the special features of genetically engineered CAR-T cells make them a particularly suitable candidate for therapeutic application in efforts to reach a functional HIV cure. The purpose of this study is to evaluate the safety and efficacy of Chidamide together with Chimeric Antigen Receptor(CAR)-T or T cell receptor(TCR)-T cell therapy based on cART in HIV-infected adults whose plasma HIV has been successfully suppressed after cART.

研究设计

研究类型
Interventional
分配方式
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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infection confirmed
  • Receiving cART more than 12 months.
  • HIV viral-load < 50 copies/ml and CD4 cell count more than 350 cells/ul.
  • Without serious liver , heart, liver and kidney diseases.
  • The subjects know about the study and volunteer to attend the research and sign the informed consent.

排除标准

  • With active HBV or HCV infection, or serious opportunistic infections.
  • With serious chronic disease such like diabetes, the mental illness,et al
  • History of suffering from pancreatitis during cART .
  • Pregnant or breast-fed.
  • With poor adherence.
  • Unable to complete follow up.

结局指标

主要结局

Incidence of treatment-associated adverse events

时间窗: 6 Months

To observe the adverse events of intervention n HIV-infected patients during the study.

次要结局

  • HIV reservoir(6 Months)

研究者

发起方
Guangzhou 8th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linghua LI

Vice Chief physician

Guangzhou 8th People's Hospital

研究点 (1)

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