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首页> 外文期刊>EBioMedicine >Thalidomide is Associated With Increased T Cell Activation and Inflammation in Antiretroviral-naive HIV-infected Individuals in a Randomised Clinical Trial of Efficacy and Safety
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Thalidomide is Associated With Increased T Cell Activation and Inflammation in Antiretroviral-naive HIV-infected Individuals in a Randomised Clinical Trial of Efficacy and Safety

机译：在有效性和安全性的随机临床试验中，沙利度胺与抗逆转录病毒初治HIV感染个体中T细胞活化和炎症增加有关

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Trial Design: Open-label, randomised, controlled, pilot proof-of-concept clinical trial. Methods: Participants: Antiretroviral naive adult males with CD4 count >=350cells/mm^3. Interventions: Patients were randomised to receive thalidomide 200mg QD for 3weeks (Thalidomide group) or not (Control group) and followed for 48weeks. Objective: We hypothesized that short-term Thalidomide use would reduce HIV related inflammation and HIV replication among antiretroviral naive HIV infected individuals. Outcome: Viral loads, CD4/CD8 counts, ultra-sensitive C-reactive protein (US-CRP), cell activation markers, and plasma lipopolysaccharide (LPS) were analyzed. Randomisation: Unrestricted randomisation. Blinding: No blinding was used. Results: Numbers randomised: Thirty recruited individuals were randomised to Thalidomide (16 patients) or Control (14 patients) groups. Recruitment: Patients were recruited from April 2011 to January 2013. Outcome: Viral loads remained stable in both groups. During thalidomide treatment, a decrease in CD4/CD8 ratio (p=0.04), a decrease in CD4 count (p=0.04), an increase in cell activation calculated by the percentage of CD38 ^+/HLA-DR^+ CD8 cells (p<0.05) and an increase in US-CRP (p<0.01) were observed in the Thalidomide group, with all parameters returning to baseline levels after thalidomide interruption. We confirmed that thalidomide increased HIV replication in vitro of 6 of 7 samples from long-term antiretroviral suppressed individuals. Harms: No class 3/4 adverse events occurred. Conclusions: Short-term use of thalidomide led to an intense transient increase in T cell activation and inflammation, with a decrease in the CD4^+ cell count without changes to the CD8^+ cell count. We confirmed that thalidomide acts in vitro as a latency reversal agent and speculate that the in vivo results obtained were due to an increase in HIV replication.
机译：试验设计：开放标签，随机，对照，试验性概念验证临床试验。方法：参与者：抗逆转录病毒天真成年男性，CD4计数> = 350cells / mm ^ 3。干预措施：患者随机接受沙利度胺200mg QD治疗3周（沙利度胺组）或不接受3d（对照组），然后随访48周。目的：我们假设短期使用沙利度胺可以减少抗逆转录病毒初次感染HIV的个体中与HIV相关的炎症和HIV复制。结果：分析了病毒载量，CD4 / CD8计数，超敏C反应蛋白（US-CRP），细胞激活标志物和血浆脂多糖（LPS）。随机化：无限制的随机化。致盲：不使用致盲。结果：随机分组：将30名新招募人员随机分为Thalidomide（16例患者）或Control（14例患者）组。招募：从2011年4月至2013年1月招募患者。结果：两组病毒载量保持稳定。沙利度胺治疗期间，CD4 / CD8比值降低（p = 0.04），CD4计数降低（p = 0.04），通过CD38 ^ + / HLA-DR ^ + CD8细胞百分比计算的细胞活化增加（沙利度胺组观察到p <0.05）和US-CRP升高（p <0.01），沙利度胺中断后所有参数均恢复到基线水平。我们证实，沙利度胺可增加来自长期抗逆转录病毒抑制个体的7个样品中6个的体外HIV复制。危害：未发生3/4级不良事件。结论：沙利度胺的短期使用导致T细胞活化和炎症的强烈瞬时增加，CD4 ^ +细胞计数减少而CD8 ^ +细胞计数没有变化。我们证实了沙利度胺在体外作为潜伏期逆转剂起作用，并推测获得的体内结果是由于HIV复制的增加。

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