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

Completed · Phase 3 · Has a placebo group

Conditions studied: HIV, Cardiovascular Diseases

In brief

People with HIV are at risk for cardiovascular disease (CVD). This study evaluated the use of pitavastatin to reduce the risk of CVD in adults with HIV on antiretroviral therapy (ART). The REPRIEVE trial consisted of two parallel identical protocols: * REPRIEVE (A5332) was funded by the NHLBI, with additional infrastructure support provided by the NIAID, and was conducted in U.S and select international sites (approximately 120 sites in 11 countries). * REPRIEVE (EU5332) was co-sponsored by NEAT ID and MGH, and was conducted at 13 sites in Spain.

Key facts

Study ID

NCT02344290

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

7769

Starts

2015-03-26

Expected to finish

2023-08-21

Last updated by the study team

2025-09-04

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona CRS — Tucson, Arizona, United States
• University of Southern California CRS* — Los Angeles, California, United States
• UCLA CARE Center CRS* — Los Angeles, California, United States
• Mills Clinical Research CRS — Los Angeles, California, United States
• VA West Los Angeles Medical Center CRS — Los Angeles, California, United States
• Los Angeles LGBT Center CRS — Los Angeles, California, United States
• Eisenhower Health Center at Rimrock CRS — Palm Springs, California, United States
• Stanford AIDS Clinical Trials Unit CRS — Palo Alto, California, United States
• UCSD Antiviral Research Center CRS* — San Diego, California, United States
• Ucsf Hiv/Aids Crs* — San Francisco, California, United States
• Harbor-UCLA CRS* — Torrance, California, United States
• University of Colorado Hospital CRS* — Aurora, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Yale University CRS — New Haven, Connecticut, United States
• VA Connecticut Healthcare System CRS — West Haven, Connecticut, United States
• Whitman-Walker Health CRS — Washington D.C., District of Columbia, United States
• Georgetown University CRS (GU CRS) — Washington D.C., District of Columbia, United States
• Capital Medical Associates, PC CRS — Washington D.C., District of Columbia, United States
• Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS — Washington D.C., District of Columbia, United States
• Malcom Randall VA Medical Center CRS — Gainesville, Florida, United States
• AHF-The Kinder Medical Group CRS — Miami, Florida, United States
• The University of Miami AIDS Clinical Research Unit (ACRU) CRS — Miami, Florida, United States
• University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS — Miami, Florida, United States
• AHF - South Beach CRS — Miami, Florida, United States
• Alabama CRS* — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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