NCT00772720Unknown1 期
Study on the Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Blood levels of total cholesterol
研究概览
简要总结
Raltegravir is the first of a new antiretroviral class. A better profile of metabolic toxicity is expected. In order to better define its effects, without interference with other drugs, a study on healthy volunteers is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male.
- •age between 18 and
- •BMI between 19 and 25 kg/m2
- •Normal physical exam.
- •Blood analysis without relevant findings.
- •Negative serology for hepatitis B, Hepatitis C and HIV.
- •Negative urine test for abuse drugs.
排除标准
- •Severe psychiatric disease.
- •Dyslipemia.
- •Alcohol intake above 30 g per day.
- •Xanthine intake above 5 coffee cup -equivalents per day
- •Use of any drugs in the last month
- •Participation in other trials in the last 3 months
- •Diseases capable to modify drug ADME
- •Drug allergy
结局指标
主要结局
Blood levels of total cholesterol
时间窗: 7 days
次要结局
- Changes in HDL, LDL and triglycerides(7 days)
- Oral glucose tolerance test(7 days)
- Mitochondrial DNA levels(7 days)
研究者
研究点 (2)
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