NCT00759070Unknown4 期
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism in ARV-naive HIV-infected Subjects
Juan A. Arnaiz5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Changes in total cholesterol and HDL and LDL fractions
研究概览
简要总结
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HIV-1 infection
- •Age 18 or above
- •Antiretroviral-naive
- •Criteria for antiretroviral therapy in accordance with current guidelines
- •Plasma LDL-cholesterol below 190 mg/dL
- •Not receiving lipid-lowering agents
- •Written informed consent
排除标准
- •Use of phytosterol-enriched food previous month.
- •Pregnancy or breastfeeding
- •Cardiovascular disease
- •Secondary Hypercholesterolemia
- •Plasma creatinine above 1,2 mg/dL)
- •Aminotransferases above 5 times ULN
- •Current treatment for hepatitis C coinfection
- •Diabetes mellitus (fasting glycemia > 124 mg/dL)
- •Illegal drug use or alcohol abuse
- •Active AIDS-defining opportunistic disease
研究组 & 干预措施
1
Active Comparator
Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV)
干预措施: Tenofovir + emtricitabine + efavirenz (Drug)
2
Active Comparator
Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV)
干预措施: Tenofovir + emtricitabine + lopinavir/ritonavir (Drug)
结局指标
主要结局
Changes in total cholesterol and HDL and LDL fractions
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona
研究点 (5)
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