Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cerebral [11C]dLop Distribution Volume
研究概览
简要总结
To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.
详细描述
Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or non-pregnant female, 18-40 yr old
- •Good general health with no remarkable medical conditions
- •BMI < 33
- •Provide informed consent
排除标准
- •Known history of liver or kidney disease
- •History of major medical conditions
- •HIV seropositive
- •Fasting blood glucose > 110 mg/dl
- •Family history of type 2 diabetes
- •Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
- •Females who are pregnant or nursing
- •Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
- •Contraindications to MRI
- •Contraindications to PET scanning
研究组 & 干预措施
Control
Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging
干预措施: [11C] desmethyl-loperamide (Drug)
Control
Session 1: Control (no pretreatment) - IV 10-14 mCi of [11C] desmethyl-loperamide (dLop) with PET/CT imaging
干预措施: Control - no pretreatment (Other)
Oral ritonavir
Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging
干预措施: [11C] desmethyl-loperamide (Drug)
Oral ritonavir
Session 2: Pretreatment with oral ritonavir for 3 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging
干预措施: Oral ritonavir (Drug)
Oral efavirenz
Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging
干预措施: [11C] desmethyl-loperamide (Drug)
Oral efavirenz
Session 3: Pretreatment with oral efavirenz for 14 days followed by IV 10-14 mCi of [11C]dLop with PET/CT imaging
干预措施: Oral efavirenz (Drug)
结局指标
主要结局
Cerebral [11C]dLop Distribution Volume
时间窗: 1 day
次要结局
未报告次要终点