Research on the Antiretroviral Therapy and Immune Reconstitution on Chinese HIV/AIDS Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- To set up a platform of antiviral therapy network all of CHINA, to obtain evidence to make first line or second line ARV treatment strategy for HIV/AIDS patients in resource limited areas.
研究概览
简要总结
This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.
详细描述
Three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3TC+D4T+NVP or AZT+3TC+NVP, 6 months later half of the 3TC+D4T+NVP group will switch to AZT+3TC+NVP, in order to observe the efficiency and safety of the first line drugs. Arm 2 will recruit 100 patients who are taking ARV for about three years already. Arm 3 will recruit 150 patients who have a Viral load of more than 1000 copies/ml, i.e., drug resistance. The second line drug 3TC+TDF+LPV/RTV will given to them and the safety and efficiency will be observed. All patients should be explored in terms of the clinical features, drugs side-effects, and immunological and viral response. The drug concentration and the metabolism changes would be explored also. Also the immune reconstitution will be studied for all patients. This study will be the first large-scale, multicentered, randomised, prospective ARV therapy study in China for HIV/AIDs patients. The result would provide proves for further practical antiviral therapy for China or other resource limited countries.
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
- Single (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
- •age between 18-65 years
- •HIV seropositive and confirmed by western blot
- •antiretroviral therapy naive for arm 1
- •CD4 cell count < 350/mm3
- •good adherence and follow up in the same place
排除标准
- •pregnancy and breastfeeding
- •AIDS defining illness or any infectious disease occured in one month but still unstable within 14 days
- •with WBC < 2000/ul, neutrophil count < 1000/ul, hemoglobin < 9 g/dl, platelet count < 75000/ul, amylase > 2 ULN, transaminase or alkaline phosphatase or total bilirubin > 2 ULN, creatinine > 2 ULT.
- •present acute or chronic pancreatitis
- •intravenous drug user
- •peripheral nephropathy
- •severe nephropathy or mental disorder
- •severe gastral ulcer
- •heart or brain arthrosclerosis
研究组 & 干预措施
Treatment-naive
To explore the efficiency and safety of generic antiretroviral drugs for 520 treatment-naive HIV/AIDS patients
干预措施: first line ARV (3TC+NVP+D4T or 3TC+NVP+AZT) (Drug)
drug resistance
To explore the second line drugs for those drug resistance patients
干预措施: second line ARV therapy (3TC+TDF+LPV/RTV) (Drug)
结局指标
主要结局
To set up a platform of antiviral therapy network all of CHINA, to obtain evidence to make first line or second line ARV treatment strategy for HIV/AIDS patients in resource limited areas.
时间窗: two years
次要结局
- Set up our own antiviral therapy guideline and drug side-effects, drug concentration and immune reconstitution result.(two years)