Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
People infected with HIV are at risk for cardiovascular disease (CVD). This study will
evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who
are on antiretroviral therapy (ART).
The REPRIEVE trial consists of two parallel identical protocols:
- REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided
by the NIAID, and is conducted in U.S and select international sites (approximately 120
sites in 11 countries).
- REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in
Spain.
Phase
Phase 3
Funding Agency/Sponsor
NIH
Disease
Other
Enrollment Eligibility
Inclusion Criteria:
- HIV-1 infected individuals
- 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 a:
- Fasting low-density lipoprotein (LDL) cholesterol as follows: If ASCVD risk score
is less than 7.5%, LDL cholesterol must be less than 190 mg/dL. If ASCVD risk
score is greater than or equal to 7.5% and less than or equal to 10%, LDL must be
less than 160 mg/dL. If ASCVD risk score is greater than 10% and less than or
equal to 15%, LDL must be less than 130 mg/dL. NOTE: If LDL is less than 70
mg/dL, participant is eligible regardless of 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 be 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 if LDL is 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.
- NOTE: Exceptions:
- Successfully treated non-melanomatous skin cancer
- 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.
NOTE: Use of oral prednisone less than or equal to 10 mg/day or equivalent dosage is
allowed.
- 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