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Eligibility
for people ages 40 years to 75 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The study is funded by the National Heart, Lung, and Blood Institute, with additional infrastructure support provided by the National Institute of Allergy and Infectious Diseases. 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).

Official Title

Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE

Details

Currently, there are few strategies to prevent CVD in HIV-infected people, even though they are at high risk for developing CVD. Statin medications are used to lower cholesterol and may be effective at reducing the risk of CVD in people infected with HIV. The purpose of this study is to evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on ART.

This study will enroll adults infected with HIV who are on any ART regimen (ART is not provided by the study) for at least 6 months before study entry considered low-to-moderate risk using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation. Total study duration will be approximately 72 months from the time the first participant is enrolled.

Participants will be randomly assigned to receive 4 mg of pitavastatin or placebo once a day for the entire time they are enrolled in the study. Study visits will occur at study entry (Day 0) and Months 1 and 4. Starting at Month 4, study visits will occur every 4 months for the rest of the study. Depending on when participants enroll, they will be in the study for a total of 3 ½ to 6 years. Study visits will include medical and medication history reviews, physical examinations, blood collections, assessments and questionnaires, urine collections (for some participants), and an electrocardiogram (ECG) (at study entry only).

Some participants will have the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE [A5333s]). The substudy will evaluate the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in adults infected with HIV. Participants in the substudy will attend study visits at study entry and Months 4 and 24. The visits will include questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA).

Keywords

HIV Infections Cardiovascular Diseases HIV Cardiovascular Disease Myocardial Infarction Inflammation Statin Computerized Tomography Cholesterol Pitavastatin

Eligibility

You can join if…

Open to people ages 40 years to 75 years

  • 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 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
  • Men and women 40 to 75 years of age
  • Ability and willingness of participant or legal representative to provide written informed consent

You CAN'T join if...

  • 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
  • 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 36 months prior to study entry (Subjects with successfully treated non-melanomatous skin cancer within 36 months prior to study entry are acceptable.)
  • Known 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 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

Locations

  • Stanford AIDS Clinical Trials Unit CRS accepting new patients
    Palo Alto, California, 94304, USA
  • University of Southern California CRS accepting new patients
    Los Angeles, California, 90033, USA
  • UCLA CARE Center CRS accepting new patients
    Los Angeles, California, 90035, USA
  • Mills Clinical Research CRS accepting new patients
    Los Angeles, California, 90069, USA
  • VA West Los Angeles Medical Center CRS accepting new patients
    Los Angeles, California, 90073, USA
  • Los Angeles LGBT Center CRS accepting new patients
    Los Angeles, California, 90232, USA
  • Eisenhower Health Center at Rimrock CRS accepting new patients
    Palm Springs, California, 92264, USA
  • UCSD Antiviral Research Center CRS accepting new patients
    San Diego, California, 92103, USA
  • Harbor-UCLA CRS accepting new patients
    Torrance, California, 90502, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
REPRIEVE Trial Website
ID
NCT02344290
Phase
Phase 3
Study Type
Interventional
Last Updated
April 2017
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