The Optimization of HAART for Chinese--a RCT Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 3
- 主要终点
- Percentage of patients with HIV RNA<50 Copies/ml
研究概览
简要总结
Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral therapy in developing countries. Based on our previous data, we aim to evaluate whether reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects while not scarifying their virological efficacy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV antibody positive
- •Chinese nationality
- •Naïve to antiretroviral therapy
- •Willing to start antiretroviral therapy
- •Provision of written informed consent
排除标准
- •Pregnant, breastfeeding, or lactating
- •Females try to get pregnant during the research period
- •Subjects who allergic to any of the research drugs
- •Subjects that taking other drugs that known to impact the absorption, distribution, metabolism and excretion of the research drugs
- •Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with treatment, assessment, compliance with the protocol, or subject safety. This would include any active clinically significant renal, cardiac, pulmonary, vascular, or metabolic (thyroid disorders, adrenal disease) illness, or malignancy
- •Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol
- •Laboratory blood values:
- •Haemoglobin <9.0 grams/decilitre (g/dL)
- •Neutrophil count <1500/mm3
- •Platelet count <75,000/mm3
- •Aspartate aminotransferase or Alanine transaminase >3 times Upper Limit of Normal (ULN)
- •Total bilirubin >3 times Upper Limit of Normal (ULN)
- •Subjects with an estimated creatinine clearance of <90 mL/minute
研究组 & 干预措施
Arm 1
Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die
干预措施: Tenofovir (Drug)
Arm 1
Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die
干预措施: Lamivudine (Drug)
Arm 1
Tenofovir 200mg + Lamivudine 300mg +Efavirenz 400mg PO Quaque die
干预措施: Efavirenz (Drug)
Arm 2
Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die
干预措施: Tenofovir (Drug)
Arm 2
Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die
干预措施: Lamivudine (Drug)
Arm 2
Tenofovir 300mg + Lamivudine 300mg +Efavirenz 600mg PO Quaque die
干预措施: Efavirenz (Drug)
结局指标
主要结局
Percentage of patients with HIV RNA<50 Copies/ml
时间窗: 48 weeks
次要结局
- Adverse events(48 weeks)
研究者
Hongzhou Lu
Doctor
Shanghai Public Health Clinical Center