NCT00771823已完成1 期
A Placebo Controlled Study of the Impact on Insulin Sensitivity and Lipid Profile of Maraviroc 300 mg Twice Daily in HIV Negative Male Volunteers
St Stephens Aids Trust1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline in insulin sensitivity by euglycaemic clamp method
研究概览
简要总结
A placebo controlled study of the impact on insulin sensitivity and lipid profile of maraviroc 300 mg twice daily in HIV negative male volunteers.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects must have documented negative HIV serology by ELISA and P24 antigen
- •Subjects must be clinically well males aged between 18 to 60 years.
- •Fasting blood glucose, total cholesterol and triglycerides within normal limits
- •Hepatic transaminases (AST and ALT) ≤ 3 × upper limit of normal (ULN)
- •Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm3; platelets ≥ 50,000/mm3; hemoglobin ≥ 8.0 g/dL)
- •Serum amylase ≤ 1.5 × ULN
- •Sexually active males must use condoms during the course of the study
- •Life expectancy ≥ 1 year
- •Willing and able to provide informed consent
排除标准
- •Subjects with a waist hip ratio > 0.97 or BMI > 28 kg/m2 will be excluded
- •Acute or chronic hepatitis B infection (determined by positive hepatitis B surface antigen result at the screening visit)
- •Acute or chronic hepatitis C infection (determined by positive hepatitis C antibody result at the screening visit)
- •Other metabolic syndrome or disease process in the opinion of the investigator likely to cause marked disturbance in glucose and lipid homeostasis including hypertension.
- •Receiving on-going therapy with any of the following:
- •Metabolically active medications
- •Any lipid-lowering medication
- •Hormonal agents (oestrogens or androgens)
- •Glucocorticoids
- •Beta-blockers
- •Thiazide diuretics
- •Thyroid preparations
- •Psychotropic agents
- •Anabolic steroids
- •Megestrol acetate
研究组 & 干预措施
2
Active Comparator
干预措施: Maraviroc (Drug)
1
Active Comparator
- Maraviroc 300 mg twice daily for the first 14 days of the study.
- Placebo twice daily for the last 14 days of the study
干预措施: Maraviroc (Drug)
结局指标
主要结局
Change from baseline in insulin sensitivity by euglycaemic clamp method
时间窗: two weeks
次要结局
- Change from baseline in serum levels of fasting cholesterol, triglycerides Changes in serum biomarkers of vascular inflammation and in CD36 PMBC and other related markers gene expression(two weeks)
研究者
研究点 (1)
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