Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Changes of T cell subsets and immune activation markers
研究概览
简要总结
This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T cell immune activation and immune activation in HIV-infected immunological non-responders. The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV immunological non-responders.
详细描述
The investigators recruited 23 patients from Peking Union Medical College Hospital Outpatient clinic. They were all immunological non-responders. Nineteen patients will receive Triptolide wilfordii Hook F extract (10mg tid po) plus current cART, while 4 patients will continue their current cART. This study will last for 12 months. Patients will be followed up at month 0, 3, 6, 9, and 12. During each follow-up time point, adverse effects, T cell subsets, T cell activation markers and other routine tests will be ordered. The investigators hypothesis that TwHF might boost CD4 cell recovery by reducing immune activation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continuous antiretroviral therapy > 18 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 300/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
TwHF extract + cART
Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
干预措施: Tripterygium Wilfordii Hook F extract (TwHF extract) (Drug)
TwHF extract + cART
Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
干预措施: cART (Drug)
cART control
Continue current cART regimen
干预措施: cART (Drug)
结局指标
主要结局
Changes of T cell subsets and immune activation markers
时间窗: 12 months
T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored.
次要结局
- Number of participants with adverse events as a measure of safety and tolerability(12 months)
- Viral load(12 months)
研究者
LI Taisheng
Professor
Peking Union Medical College