NCT00184951已完成2 期
Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- pharmacokinetics on week 0,4,8 and 12
研究概览
简要总结
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
详细描述
To determine the effect of rosuvastatin on plasma lipids, lipoproteins, and endothelial function in HIV-infected patients on stable lopinavir/ritonavir therapy and to evaluate the safety of combined use of rosuvastatin and lopinavir/ritonavir. Also to determine the effect of lopinavir/ritonavir on the pharmacokinetics of rosuvastatin compared to historical controls an to determine the effect of rosuvastatin on the pk of lopinavir/ritonavir compared to historical controls and by intrapatient comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •use of lopinavir 400mg/ritonavir 100mg bid > 3months
- •HIV-1 RNA <400cop/mL
- •fasting total cholesterol > 6.2mmol/L
排除标准
- •history of sensitivity/idiosyncrasy to the drug or compounds used
- •history or current condition that might interfere with absorption,distribution metabolism or excretion
- •pregnant or breast-feeding
- •serum transaminase levels >3 times upper limit of normal, creatinine clearance <60ml/min
- •fasting plasma triglycerides level >8.0 mmol/L
- •history of statin-related rhabdomyolysis or inheritable muscle diseases in family history
- •clinical symptoms of myopathy or abnormal CK level
- •change in antiretroviral medication within the 3 months immediately preceding first dose of rosuvastatin
- •use of any statin or fibrate within 6 weeks immediately preceding first dose of rosuvastatin
- •concomitant use of medications that interfere with rosuvastatin or lopinavir pharmacokinetics
- •active hepatobiliary or hepatic disease
- •hypothyroidism
- •alcohol abuse
- •japanese or chinese patients
结局指标
主要结局
pharmacokinetics on week 0,4,8 and 12
次要结局
- endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)
- evaluation of lipid lowering activity on week 0,4,8,12
研究者
研究点 (5)
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