NCT00405171已完成4 期
Efavirenz to Nevirapine Switch in HIV-1 Infected Patients With Severe Dyslipidemia: A Randomized Controlled Study
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Decrease in LDL cholesterol between baseline and week 52
研究概览
简要总结
Dyslipidemia and coronary heart disease (CHD) are increasingly recognized in persons with human immunodeficiency virus (HIV) infection. Many antiretrovirals, including efavirenz (EFV), are associated with increases in serum lipids. The investigators investigated whether stopping EFV and replace EFV by nevirapine can reduce significantly Low-Density Lipoprotein cholesterol, while keeping virologic control of HIV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infected adults, who were receiving antiretroviral therapy including efavirenz for at least 6 months
- •plasma HIV RNA<400 cp/ml during the previous 4 months on 2 occasions 14 days apart
- •Severe dyslipidemia with Low-Density Lipoprotein cholesterol (LDL-c) >3.4 mmol/L in the presence of at least one of the 3 following coronary heart disease (CHD) risk factors: age>45 among males or age>55 among females, hypertension, current smoking, family history of CHD
- •Low-Density Lipoprotein cholesterol (LDL-c)>4.1 mmol/L regardless of CHD risk factors.
排除标准
- •Protease inhibitors use within the previous 6 months,
- •Prior exposure to nevirapine
- •Asparate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5N if hepatitis virus B or C were negative
- •AST or ALT>1.25N if hepatitis virus B or C were positive
- •Fasting glycemia>1.26g/L,
- •Current CHD
- •Triglycerides>4.6 mmol/L
- •Introduction of lipid lowering drugs, corticoïds, retinoïds and betablockers within the previous 3 months.
结局指标
主要结局
Decrease in LDL cholesterol between baseline and week 52
次要结局
未报告次要终点
研究者
研究点 (2)
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