Effect of Chidamide Combined With CAT-T or TCR-T Cell Therapy on HIV-1 Latent Reservoir
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
- 否
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
Linghua LI
Vice Chief physician
Guangzhou 8th People's Hospital
