NCT00657761已完成4 期
Effect of Enfuvirtide on Lipid and Glucose Metabolism and Mitochondrial Function in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in fasting plasma total cholesterol
研究概览
简要总结
The metabolic effects of T-20 are not completely known, since the drug is used in combination with other antiretroviral agents. A short-term study in healthy volunteers, with a double-blind crossover design vs. placebo will illustrate if there may be some direct metabolic effects without the influence of HIV infection and the concurrent use of other drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 adult males
- •BMI between 19-24.9 kg/m2
- •No active concomitant clinical conditions
- •Negative HIV, HBV and HCV serologies
- •Negative abuse drug urine test
排除标准
- •Prior psychiatric illness
- •Prior dyslipemia
- •Alcohol consumption > 30g/day
- •Caffeine consumption > 5 units/day
- •Current smoker
- •Known drug allergies
- •Participation in other drug trials in the previous 3 months
- •No medications in the previous 30 days
研究组 & 干预措施
Enfuvirtide
Experimental
Enfuvirtide 90 mg/12h sc for 7 days
干预措施: Enfuvirtide (Drug)
Placebo
Placebo Comparator
Saline solution 0.9% sc/12h for 7 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in fasting plasma total cholesterol
时间窗: 6 weeks
次要结局
- Changes in LDL- and HDL- cholesterol, triglycerides, oral glucose tolerance test, lactate and mt-DNA(6 weeks)
研究者
研究点 (1)
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