Study of Triptolide Woldifiion T Cell Immune Activation and Inflammation Biomarkers in HIV-infected Immunological Non-responders
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Changes of T cell immune activation and inflammation biomarkers
研究概览
简要总结
This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation biomarkers in HIV-infected immunological non-responders.
详细描述
About 120 patients will be recruited from 4 HIV/AIDS clinical centers in China and randomized 1:1 into intervention group and placebo-controlled group. Triptolide wilfordii (20mg tid po) would be given to invention group for 24 weeks. T cell activation and inflammation biomarkers including CD8+HLA-DR+CD38+, IL-6, D-Dimer and high-sensitivity C-reactive protein (hsCRP), protein degradation-1 (PD-1), Ki67 ,soluble CD14 and CD163, PD-1, CCR5 and CD57 would be tested. Patients in placebo-controlled group will change to take Triptolide wilfordii (20mg tid po) for another 24 weeks. All patients will be followed up till 48 weeks. We hypothesis that Triptolide wilfordii might reduce immune activation and inflammation of HIV immunological non-responders and increase CD4 T cell count, which provides a new strategy for treatment of HIV-infected immunological non-responders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous antiretroviral therapy > 24 months ， and consistent HIV-RNA< 40 copies/mL more than 12 months ;
- •18-65 years old;
- •Male or female;
- •Good adherence and promise to follow-up;
- •Inform Consent signed;
- •CD4 T cells less than 250/ul .
排除标准
- •Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
- •hemoglobin (HGB) < 9 g/dl 、 white blood cell (WBC) < 2000/ul 、 granulin (GRN) < 1000 /ul 、 platelet (PLT) < 75000 /ul 、 Cr >1.5x ULN 、 ALT or AST or alkaline phosphatase (ALP) >3x upper limit of normal (ULN) 、 total bilirubin (TBIL) >2x ULN 、 creatine kinase (CK) > 2x ULN;
- •Pregnant or breastfeeding woman or woman with pregnancy plan;
- •Active drug-user;
- •Severe neurological defects;
- •Active alcohol abuse;
- •Severe gastrointestinal ulcer .
- •End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc
- •Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
研究组 & 干预措施
placebo + cART
combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months
干预措施: Triptolide (Drug)
placebo + cART
combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months
干预措施: cART (Drug)
placebo + cART
combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months
干预措施: placebo (Drug)
Triptolide + cART
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
干预措施: Triptolide (Drug)
Triptolide + cART
combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.
干预措施: cART (Drug)
结局指标
主要结局
Changes of T cell immune activation and inflammation biomarkers
时间窗: baseline and at 4,8,12,24,36,48 weeks
T cell activation and inflammatory biomarkers including CD8+HLA-DR+/CD38+, IL-6, D-dimer and hsCRP,soluble CD14 and CD163, PD-1, CCR5 and CD57 should be measured at baseline and at Wee4, W12, W24, W36, W48 follow-up visits.
次要结局
- Changes of CD4 T cell count and number of participants with adverse events(baseline and at 4,8,12,24,36,48 weeks)
研究者
LI Taisheng
Peking Union Medical College Hospital
Peking Union Medical College