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临床试验/CTRI/2017/10/010020
CTRI/2017/10/010020招募中4 期

Randomized Trial to Prevent Vascular Events in HIV

IH0 个研究点目标入组 0 人开始时间: 待定最近更新:
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试验速览

阶段
4 期
状态
招募中
发起方
IH
研究概览入排标准研究者记录与标识符相似试验

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.Documentation ofHIV-1 infection by means of any one of the following:
  • •.Documentation of HIV diagnosis in the medical record by a licensed health care provider;
  • •OR HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL;
  • •OR any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid Multispot antibody differentiation assay.
  • •2.Combination antiretroviral therapy (ART) for at least 180 days prior to study entry.
  • •3.CD4+ cell count >100 cells/mm3 obtainedwithin 180 days prior to study entry.
  • •4.Laboratory values drawn at screen and/or obtained from clinical care (as indicated in section 6.1 Schedule of Events) within 90days prior to study entry.
  • •Fasting LDL cholesterol as follows
  • •ASCVD RISK SCORE LDL CHOLESTEROL
  • •<7.5% <190
  • •>7.5%- <10% <160
  • •>10%- >15% <130
  • •If LDL Less that 70mg/dl participant is eligible regardless of ASCVD RISK SCORE
  • •Fasting triglycerides <500 mg/dL
  • •Hemoglobin ï?³8 g/dL for female subjects and ï?³9 g/dL for male subjects
  • •Calculated creatinine clearance (CrCl) ï?³60 mL/min OR Glomerular filteration rate (GFR)more than 60 ml/min/1.73m2
  • •ALT <=2.5 x ULN
  • •NOTE:Subjects co-infected with chronic active hepatitis B or C must have ALT <=2 x ULN.
  • •5.For persons with known chronic active hepatitis B or C, calculated FIB-4 score must be <=3.25.
  • •NOTE:Active is defined as hepatitis B surface antigen positive, hepatitis B DNA positive, or hepatitis C RNA positive.
  • •6. Female subjects of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months, ie, who have had menses within 24 months prior to study entry, and women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy) must have a negative serum or urine pregnancy test within 48 hours prior to entry
  • •NOTE:Subject-reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, andmenopause. Women are considered menopausal if they have not had a menses for at least 12 months and have a FSH (follicle stimulating hormone) of greater than 40 IU/L or, if FSH testing is not available, they have had amenorrhea for 24 consecutive months.
  • •7.For women of reproductivepotential, willingness to use contraceptives as describedin the product information for pitavastatin. Contraceptives must be used at least two weeks before initiation of study drug and must be continued 6 weeks after cessation of study drug.
  • •If participating in sexual activity that could lead to pregnancy, women must use a form of contraceptive. At least one of the following methods must be used appropriately:
  • •Condoms (male or female) with or withoutspermicidal agent
  • •Diaphragm or cervical cap with spermicidal agent
  • •Intrauterine device (IUD)
  • •Hormone-based contraceptive
  • •Tubal ligation
  • •Tubal micro-inserts
  • •Women who are not of reproductive potential as defined

排除标准

  • •1.Clinical ASCVD, as defined by 2013 ACC/AHA guidelines, including a previous
  • •diagnosis of any of the following:
  • •Acute coronary syndromes
  • •Stable or unstable angina
  • •Coronary or other arterial revascularization
  • •Peripheral arterial disease presumed to be of atherosclerotic origin
  • •2.Current diabetes mellitusif LDL >=70mg/dL
  • •NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, eg,women with a history of gestational diabetes, steroid-induced or medication-induced.
  • •3.10-year ASCVD risk score estimated by Pooled Cohort Equations >15%
  • •4.Active cancer within 12 months prior to study entry.
  • •5.Known decompensated cirrhosis.
  • •6.History of myositis or myopathy with active disease in the 180 days prior to study entry.
  • •7.Known untreated symptomatic thyroid disease.
  • •8.History of allergy or severe adverse reaction to statins.
  • •9.Use of specific immunosuppressants or immunomodulatory agents including but not limited to tacrolimus, sirolimus, rapamycin, mycophenolate, cyclosporine, 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 <=10mg/day is allowed.
  • •10Current use of erythromycin, colchicine, or rifampin.
  • •11Use of statin drugs or gemfibrozil, PCSK9 inhibitors in the 90 days prior to study entry.
  • •NOTE: Use of niacin as part of a multivitamin is not exclusionary.
  • •12.Current use of an investigational new drugthat would be contraindicated.
  • •13.Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry.
  • •14.Known active or recent (not fully resolved within 30 days prior to study entry) systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human papillomavirus [HPV], or HCV).
  • •15.Current breastfeeding.
  • •16.Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures.
  • •17.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.

研究者

发起方
IH

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