Changes in Insulin Resistance in Healthy Volunteers on STRIBILD® Medication - A Controlled, Mono Center, Three-arm, Randomized Phase I Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
研究概览
简要总结
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
详细描述
The measurement of insulin resistance will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14 days (+/- 2 days) of treatment with STRIBILD® (treatment 1, n=10), as compared to TVD, LPV/r (treatment 2, n=10) and TVD, DRV/r (treatment 3, n=10). The volunteers will be randomly assigned to one of three groups. The measurement of insulin resistance, lipid and glucose metabolism will be performed; before and immediately after the treatment. Furthermore, the therapy compliance will be verified using the method of drug counting and therapeutic drug monitoring (TDM).
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers, age 18-40 years
- •Informed consent and willingness in study participation
- •Birth control during study period
排除标准
- •Participation in other clinical trials
- •Contraindication or known allergy to study medication
- •Known metabolic disease incl. Diabetes mellitus, Hypertriglyceridemia or others
- •Known alcohol or nicotine abuse
- •HIV infection
- •History of pharmaceutical study in the last 4 weeks
- •BMI < 18 > 25
- •Long-term or regular medication
- •Known liver-, renal-, cardiovascular, lung, gastrointestinal, endocrine, neurologic, psychiatric or metabolic disorder
- •Dependence to study center or coordinator
- •Inmates or psychiatric treatment
研究组 & 干预措施
Group I
STRIBILD® Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat
干预措施: Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat (Drug)
Group II
Truvada®/Kaletra® Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir
干预措施: Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir (Drug)
Group III
Truvada®/Prezista®/Norvir® Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir
干预措施: Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir (Drug)
结局指标
主要结局
Changes in insulin resistance, measured by hyperinsulinemic euglycemic clamp
时间窗: Day 14
Changes in insulin resistance in healthy volunteers with normal body weight (BMI 18-25) after 14 days of STRIBILD®-, Truvada®/Kaletra® or Truvada®/Prezista®/Norvir® intake, measured by hyperinsulinemic euglycemic clamp.
次要结局
- Changes in metabolic parameters(Day 14)