Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Changes of the immunologic response, virologic response, and hiv-1 reservoir
研究概览
简要总结
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.
详细描述
Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •• age between 18-65 years
- •HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection
- •good adherence and follow up in the same place
- •Inform Consent signed
- •ART-naïve
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
Triptolide group
cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months
干预措施: Triplitode (Drug)
Comparator group
combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
干预措施: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir (Drug)
结局指标
主要结局
Changes of the immunologic response, virologic response, and hiv-1 reservoir
时间窗: baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits
次要结局
- Adverse events of the therapy(thirty-six months)
研究者
LI Taisheng
department of the infectious disease
Peking Union Medical College