CTRI/2017/08/009558已完成3 期
REPRIEVE (A5332) Randomised Trial to Prevent Vascular Events in HIV - A5332
IH DAIDS0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 HIV 1 infected individuals
- •2 Combination antiretroviral therapy ART for at least 180 days prior to study entry
- •3 CD4 plus cell count greater than 100 cells per mm cube
- •4 Acceptable screening laboratories including a
- •Fasting low-density lipoprotein LDL cholesterol as follows If ASCVD risk score is less than 7.5 percent LDL cholesterol must be less than 190 mg per dL
- •If ASCVD risk score is greater than or equal to 7.5 percent and less than or equal to 10 percent LDL must be less than 160 mg per dL
- •If ASCVD risk score is greater than 10 percent and less than or equal to 15percent LDL must be less than 130 mg per dL
- •NOTE If LDL is less than 70 mg per dL participant is eligible regardless of risk score in line with the ACC AHA 2013 Prevention Guidelines
- •Fasting triglycerides less than 500 mg per dL
- •Hemoglobin greater than or equal to 8 g per dL for female participants and greater than or equal to 9 g per dL for male participants
- •Glomerular filtration rate GFR greater than or equal to 60 mL per min per 1.73m square or creatinine clearance CrCl greater than or equal to 60 mL per min
- •Alanine aminotransferase ALT less than or equal to 2.5 times the upper limit of normal
- •5 For persons with known chronic active hepatitis B or C calculated fibrosis 4 score FIB-4 must be less than or equal to 3.25
- •6 Men and women 40 to 75 years of age
- •7 Ability and willingness of participant or legal representative to provide written informed consent
排除标准
- •1 Clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines, including a previous diagnosis of any of the following:
- •Acute myocardial infarction (AMI)
- •Acute coronary syndromes
- •Stable or unstable angina
- •Coronary or other arterial revascularization
- •Transient ischemic attack (TIA)
- •Peripheral arterial disease presumed to be of atherosclerotic origin
- •2 Current diabetes mellitus if LDL is greater than or equal to 70 mg/dL
- •3 10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15%
- •4 Active cancer within 36 months prior to study entry (Subjects with successfully treated non-melanomatous skin cancer within 36 months prior to study entry are acceptable.)
- •5 Known cirrhosis
- •History of myositis or myopathy with active disease in the 180 days prior to study entry
- •6 Known untreated symptomatic thyroid disease
- •7 History of allergy or severe adverse reaction to statins
- •8 Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, tumor necrosis factor (TNF)-alpha blockers or antagonists, azathioprine, interferon, growth factors, or intravenous immunoglobulin (IVIG) in the 30 days prior to study entry. NOTE: Use of oral prednisone less than or equal to 10 mg/day is allowed.
- •9 Current use of erythromycin, colchicine, or rifampin
- •10 Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry
- •11 Current use of an investigational new drug that would be contraindicated
- •12 Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry
- •13 Current pregnancy or breastfeeding
- •14 Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures
- •15 Other medical, psychiatric, or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures and or adherence to study drug
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