An Open Label Study of the Impact on Insulin Sensitivity, Lipid Profile and Vascular Inflammation by Treatment With Lopinavir / Ritonavir (400 / 100 mg Twice Daily) or Raltegravir 400 mg Twice Daily in HIV Negative Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 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
The purpose of the study is to look at the effects of two different HIV medications on the body's response to insulin (a hormone that regulates blood sugar levels). This will be done using a method called the 'euglycaemic clamp'
The study will also investigate the effects of these drugs on blood fats and on circulating markers in the blood stream related to blood vessels (vascular inflammation markers).
详细描述
Subjects will undergo four euglycaemic clamp procedures in order to determine the extent of glucose disposal. The first clamp will be performed prior to the commencement of the first study drug administration, the second one following two weeks of study drug, the third after a two week washout period, prior to commencement of second study drug administration and the fourth after two weeks of the second study drug
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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 (subjects with serum amylase > 1.5 × ULN will remain eligible if pancreatic lipase is ≤ 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
1
Raltegravir 400 mg twice daily for the first 14 days of the study. Lopinavir/ritonavir 400/100 mg twice daily for the last 14 days of the study
干预措施: Raltegravir then lopinavir/ritonavir (Drug)
2
- Lopinavir/ritonavir 400/100 mg twice daily for the first 14 days of the study.
- Raltegravir 400 mg twice daily for the last 14 days of the study.
干预措施: Lopinavir/ritonavir then raltegravir (Drug)
结局指标
主要结局
Change from baseline in insulin sensitivity by euglycaemic clamp method
时间窗: 2 weeks
次要结局
- Change from baseline in serum levels of fasting cholesterol, triglycerides(2 weeks)