NCT01935674已完成4 期
Rosuvastatin Versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults
Juan A. Arnaiz1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2013年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Percentage Change From Baseline in Total Cholesterol at 12 Weeks.
研究概览
简要总结
To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
详细描述
To compare the effects of rosuvastatin to protease inhibitor switching on:
- Total cholesterol through week 12
- Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy)
- Quality of life (SF-12)
- Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides
- Fasting glucose and insulin
- Framingham cardiovascular risk score
- D:A:D 5-year estimated risk calculator
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-positive status
- •Adults (≥18 years of age)
- •Stable and well-tolerated combination ART including a ritonavir-boosted protease inhibitor for the previous 6 months
- •HIV RNA <50 copies/mL for at least the preceding 3 months
- •Fasting total cholesterol ≥5.5 mmol/L (>213 mg/dL)
- •Framingham risk score ≥8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
- •Provision of written, informed consent
- •Exclusion criteria:
- •Any statin in the previous 12 weeks
- •Previous statin-induced myopathy or hepatitis
- •History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
- •Concurrent use of:
- •oral corticosteroids use other than for replacement therapy (i.e. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
- •other immunosuppressive or immunomodulating drugs
- •Contraindication to rosuvastatin therapy:
- •liver transaminases >5 times the upper normal limit
- •creatinine clearance <30 mL/min
- •known myopathy
- •current fibrate therapy
- •known resistance to one or more "backbone" ART drugs
- •No potent switch ART drug available to replace the current ritonavir-boosted protease inhibitor
- •Known intolerance to rosuvastatin or the proposed switch ART drug
- •Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
- •A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study
- •Unable to complete study procedures
排除标准
- 未提供
研究组 & 干预措施
Switch ritonavir-boosted PI
Experimental
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
干预措施: Switch ritonavir-boosted PI (Drug)
Continue ritonavir-boosted PI+Rosuvastatin
Experimental
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
干预措施: Continue Ritonavir-boosted PI+Rosuvastatin (Drug)
结局指标
主要结局
Percentage Change From Baseline in Total Cholesterol at 12 Weeks.
时间窗: 12 weeks from baseline (week 0 to week 12)
The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.
次要结局
- Total Cholesterol Through Week 12(12 weeks)
- Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)(12 weeks)
- Quality of Life (SF-12)(12 weeks)
- Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides(12 weeks)
- Fasting Glucose and Insulin.(12 weeks)
- Framingham Cardiovascular Risk Score (10-year Risk Estimate)(Screening and week 12)
- D:A:D 5-year Estimated Risk Calculator.(Screening and week 12.)
研究者
Juan A. Arnaiz
Project manager
Hospital Clinic of Barcelona
研究点 (1)
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