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