Peking Union Medical College Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change from Baseline Virological measurements at 12 weeks
研究概览
简要总结
The present study will be a randomized controlled study in which 500 treatment-naive HIV patients will be randomized 1:1 to Efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. The whole cohort will be followed for two years. Efficacy and safety of each regimen will be evaluated throughout the study.
详细描述
As efaviren has been commonly used as the first-line therapy in HIV infection worldwide, its major side effect i.e. the mental effects have been noticed and has a major influence on the adherence and efficacy of ART regimen. Mental effects of efaviren have been especially critical in Chinese patients, as the effective and toxic ranges of efaviren plasma concentration in Chinese patients are very close to each other.
In this study, 500 treatment-naive Chinese patients with a body weight < 60kg will be screened and recruited. Patients will be randomized 1:1 to efaviren 400mg v.s. 600mg combined with lamivudine and tenofovir. All patients will be followed regularly for 2 years, at 0, 2w, 4w, 3m and every 3 months. Virological and immunological measurements will be done at each visit. Meanwhile, various mental scales will be performed at each visit to evaluate the mental effects of each arm.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Willingness and availability to engage in study activities for the duration of the study
- •Age between 18-65
- •Documented HIV-1 infection (confirmed by Western blot)
- •Received no prior antiretroviral therapy
排除标准
- •Pregnancy or breastfeeding or anticipated pregnancy in two years
- •History of AIDS-defining illness
- •Hemoglobin < 9g/dl；or peripheral white blood cell counts < 2000/μl；or neutrophil counts < 1000 /μl；or platelet count < 75,000/μl；
- •Liver disease (transaminase and alkaline phosphatase levels more than three times the upper limit of the normal range (ULN), bilirubin level more than 2.5 times the ULN)
- •Chronic kidney disease (serum creatinine level more than 1.5 times the ULN)
- •Patients with a history of injection drug usage
- •Patients with a history of mental disorders
研究组 & 干预措施
Efavirenz 400MG Oral Tablet
Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 400mg per day as antiretroviral treatment.
干预措施: Efavirenz 400Mg Oral Tablet (Drug)
Efavirenz 600MG Oral Tablet
Recruited treatment-naive HIV infected patients will be given Lamivudin 300mg per day, tenofovir 300mg per day and efavirenz 600mg per day, per standard dose.
干预措施: Efavirenz 600Mg Oral Tablet (Drug)
结局指标
主要结局
Change from Baseline Virological measurements at 12 weeks
时间窗: 12 weeks
Plasma viral load
Change from Baseline Virological measurements at 24 weeks
时间窗: 24 weeks
Plasma viral load
Change from Baseline Virological measurements at 48 weeks
时间窗: 48 weeks
Plasma viral load
Change from Baseline Virological measurements at 72 weeks
时间窗: 72 weeks
Plasma viral load
Change from Baseline Virological measurements at 96 weeks
时间窗: 96 weeks
Plasma viral load
Change from Baseline Immunological measurements at 12 weeks
时间窗: 12 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 24 weeks
时间窗: 24 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 48 weeks
时间窗: 48 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 72 weeks
时间窗: 72 weeks
CD4 T cell count
Change from Baseline Immunological measurements at 96 weeks
时间窗: 96 weeks
CD4 T cell count
次要结局
- Adverse effects measured by Dizziness Handicap Inventory(0, 12, 24, 48, 72, 96 weeks)
- Adverse effects measured by Hamilton Depression Scale-24(0, 12, 24, 48, 72, 96 weeks)
- Adverse effects measured by Pittsburgh Sleep Quality Index(0, 12, 24, 48, 72, 96 weeks)
研究者
LI Taisheng
Chief, Department of Infectious Diseases
Peking Union Medical College Hospital