High Intensity Lipid Lowering Following Acute Coronary Syndromes for Persons Living With Human Immunodeficiency Virus (HILLCLIMBER)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean Percent Change in Fasting LDL-cholesterol
研究概览
简要总结
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy (pravastatin 40mg daily) versus high-dose statin therapy (rosuvastatin 20-40mg daily) in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
详细描述
HILLCLIMBER is a randomized, controlled, open-label phase II trial of moderate dose statin therapy versus high-dose statin therapy in HIV-infected persons taking antiretroviral therapy (ART) who have coronary heart disease (CHD).
All subjects will have an initial 2-week run-in period with pravastatin 40mg daily (Week 0 to 2). Subjects not demonstrating significant toxicity at week 2 will then be randomized to rosuvastatin 20mg (high intensity dose group) versus continuing pravastatin 40mg daily (moderate intensity group) for 12 weeks (Weeks 2 to 14). At week 6, those in the rosuvastatin arm who do not demonstrate significant toxicity and whose LDL-c is >60mg/dl and decreased by less than 25% compared with week 2 will then have doses increased to rosuvastatin 40mg.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 infection
- •HIV RNA below the lower limit of assay detection within 12 months of study entry
- •Documented coronary heart disease (CHD): nonfatal MI, unrecognized MI, unstable angina pectoris, and/or stable angina pectoris, as defined by the American Heart Association Case Definitions for Acute Coronary Heart Disease in Epidemiology and Clinical Research Studies, OR Or (2) Documented 10-year ASCVD risk of 15% or greater based on the ACC/AHA ASCVD Risk Estimator
- •Negative serum or urine pregnancy test
- •Men and women age 18 to 75 years of age
排除标准
- •Serious illness or AIDS-related complication within 21 days of screening requiring systemic treatment and/or hospitalization
- •No coronary heart disease (CHD) and 10-year ASCVD risk <15.0%.
- •Not currently receiving antiretroviral therapy or taking any of the following antiretroviral agents: atazanavir/ritonavir, lopinavir/ritonavir.
- •History of statin intolerance leading to discontinuation, dose decrease, or change to less potent dose equivalent
- •Statin absolute contraindication
- •Current use of atorvastatin 20mg daily or greater or rosuvastatin 10mg daily or greater
- •Chronic kidney disease stage 4 or greater (including dialysis)
- •Systolic heart failure with last documented LVEF <35%
- •Pregnant or breastfeeding
- •Laboratory values obtained within 45 days prior to study entry:
- •LDL-c <80 mg/dl while not on statin or LDL-c <60 mg/dl while on statin ALT > 3 x Upper Limit of Normal (ULN) AST > 3 x ULN Creatinine kinase (CK) >3 x ULN (calculated creatinine clearance (CrCl) <50 mL/min, as estimated by the Cockcroft-Gault equation)
- •Life expectancy <12 months
- •Prior organ transplant
- •Active malignancy
- •Inflammatory muscle disease
研究组 & 干预措施
Moderate Intensity Group
pravastatin 40mg daily for 12 weeks
干预措施: Pravastatin (Drug)
High Intensity Group
rosuvastatin 20 - 40 mg daily for 12 weeks
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Mean Percent Change in Fasting LDL-cholesterol
时间窗: Week 2 and Week 14
Mean percent change in fasting LDL-cholesterol at Week 2 and Week 14
Treatment-emergent Adverse Events
时间窗: 14 weeks
Number of Grade 3 or above adverse events
次要结局
未报告次要终点
研究者
Matthew Feinstein
Assistant Professor of Medicine and Preventive Medicine
Northwestern University