The Effect of Arsenic Trioxide on Eliminating HIV-1 Reservoir Combined With cART
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART
研究概览
简要总结
To evaluate the safety and efficacy of arsenic trioxide combined with cART in eliminating latent HIV-1 reservoir, providing potential strategies for AIDS functional cure.
详细描述
Although combined antiretroviral therapy (cART) could control human immunodeficiency virus type 1 (HIV-1) infection, the persistence of HIV-1 viral reservoir make it extremely difficult to achieving cure of AIDS. The shock and kill strategy has been extensively practiced. The latency reversing agents (LRAs) could reactivate latent HIV-1 and then the reactivated virus could be eradicated. However, no appropriate activator has been found nor manufactured. Our previous work found that the arsenic trioxide, clinically approved for treating acute promyelocytic leukemia,could efficiently reactivate latent provirus in CD4+T cells from HIV-1 patients and Simian immunodeficiency virus (SIV)-infected macaques, without significant systemic T cell activation and inflammatory responses. In this study, we are going to study the safety of and efficacy of arsenic trioxide combined with cART in 20 HIV-1 infected patients, by observing adverse events,HIV-1 reservoir, HIV-1 load, and some immune index.
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 HAART more than 12 months.
- •HIV viral-load < 50 copies/ml and CD4+ cell count more than 350 cells/ul.
- •Without serious heart, lung, liver or kidney disease.
- •Participants know about the study and sign informed consent.
排除标准
- •With serious active HBV or HCV infection or opportunistic infections
- •With serious chronic disease such as diabetes, mental illness,et al
- •History of suffering from pancreatitis during HAART.
- •Pregnant or breast-fed.
- •With poor adherence.
- •Unable to complete the follow up.
研究组 & 干预措施
Arsenic trioxide combined with cART
Receiving intravenous arsenic trioxide, 0.16mg/kg/day, no more than 10 mg per-day , two to four weeks, combined with continuous cART after attaining plasma HIV-1 suppression (plasma HIV RNA <50 cp/ml) and CD4+ cell count more than 350 cells/ul over 1 year by cART, without active HCV or HBV infection or opportunistic infections.
干预措施: Arsenic Trioxide (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events of arsenic trioxide combined with cART
时间窗: 6 Months
To observe the adverse events of arsenic trioxide combined with cART when treating with HIV-infected patients during the clinical trial
次要结局
- HIV-1 reservoir(6 Months)
研究者
Linghua LI
Vice Chief physician
Guangzhou 8th People's Hospital