Health Condition 1: null- HIV infected patients with cardiovascular disease
Conditions
Interventions
Intervention1: Pitavastatin
One tablet 4 mg taken once daily orally with or without food: Participants will receive pitavastatin once a day for the entire time they are enrolled in the study.
Control
Sponsors
NIH DAIDS
B J GOVT Medical College
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 Stroke 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first event of a composite of major cardiovascular events Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary or peripheral arterial revascularization, nonfatal stroke or transient ischemic attack (TIA), urgent peripheral arterial disease (PAD) ischemic event (acute or chronic limb ischemia, amputation, etc.)Timepoint: Measured through participants final study visit, at approximately Month 42 to 72 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first of each individual component of the primary endpoint Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary or peripheral arterial revascularization, nonfatal stroke or TIA urgent PAD ischemic event acute or chronic limb ischemia, amputation Time to death (all-cause mortality) and/or major adverse cardiovascular events (MACE) Timepoint: Measured through participants final study visit at approximately Month 42 to 72 | — |
Countries
Botswana, Brazil, Canada, South Africa, Thailand, United States of America
Contacts
Public ContactDr Nishi Suryavanshi
B J Govt Medical College
Outcome results
None listed