Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults

Inclusion Criteria

• Individual with HIV-1
• Combination antiretroviral therapy (ART) for at least 180 days prior to study entry
• CD4+ cell count greater than 100 cells/mm^3
• Acceptable screening laboratories including:
• Fasting low-density lipoprotein (LDL) cholesterol as follows:
• If ASCVD risk score was less than 7.5%, LDL cholesterol must have been less than 190 mg/dL.
• If ASCVD risk score was greater than or equal to 7.5% and less than or equal to 10%, LDL must have been less than 160 mg/dL.
• If ASCVD risk score was greater than 10% and less than or equal to 15%, LDL must have been less than 130 mg/dL.
• Participants with LDL less than 70 mg/dL were eligible regardless of the 10-year ASCVD risk score, in line with the ACC/AHA 2013 Prevention Guidelines.
• Fasting triglycerides less than 500 mg/dL
• Hemoglobin greater than or equal to 8 g/dL for female participants and greater than or equal to 9 g/dL for male participants
• Glomerular filtration rate (GFR) greater than or equal to 60 mL/min/1.73m^2 or creatinine clearance (CrCl) greater than or equal to 60 mL/min
• Alanine aminotransferase (ALT) less than or equal to 2.5 x the upper limit of normal (ULN)
• For persons with known chronic active hepatitis B or C, calculated fibrosis 4 score (FIB-4) must have been less than or equal to 3.25
• Ability and willingness of participant or legal representative to provide written informed consent

Exclusion Criteria

• Clinical 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
• Current diabetes mellitus with LDL greater than or equal to 70 mg/dL
• 10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15%
• Active cancer within 12 months prior to study entry, except successfully treated non-melanomatous skin cancer and Kaposi sarcoma without visceral organ involvement
• Known decompensated cirrhosis
• History of myositis or myopathy with active disease in the 180 days prior to study entry
• Known untreated symptomatic thyroid disease
• History of allergy or severe adverse reaction to statins
• 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.
• Current use of erythromycin, colchicine, or rifampin
• Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry
• Current use of an investigational new drug that would be contraindicated
• Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry
• Current pregnancy or breastfeeding
• Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures
• 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