1. Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)
- Author
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Grinspoon, Steven K, Fitch, Kathleen V, Overton, Edgar Turner, Fichtenbaum, Carl J, Zanni, Markella V, Aberg, Judith A, Malvestutto, Carlos, Lu, Michael T, Currier, Judith S, Sponseller, Craig A, Waclawiw, Myron, Alston-Smith, Beverly, Cooper-Arnold, Katharine, Klingman, Karin L, Desvigne-Nickens, Patrice, Hoffmann, Udo, Ribaudo, Heather J, Douglas, Pamela S, and Investigators, on behalf of the REPRIEVE
- Subjects
Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Trials and Supportive Activities ,Patient Safety ,Heart Disease ,Infectious Diseases ,HIV/AIDS ,Prevention ,Clinical Research ,Cardiovascular ,Atherosclerosis ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,Adult ,Aged ,Anti-HIV Agents ,Cardiovascular Diseases ,Cholesterol ,LDL ,Double-Blind Method ,Female ,HIV Infections ,Humans ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Male ,Middle Aged ,Primary Prevention ,Prospective Studies ,Quinolines ,Risk Factors ,REPRIEVE Investigators ,Cardiorespiratory Medicine and Haematology ,Public Health and Health Services ,Cardiovascular System & Hematology ,Cardiovascular medicine and haematology - Abstract
BackgroundCardiovascular disease (CVD) is more frequent among people with HIV (PWH) and may relate to traditional and nontraditional factors, including inflammation and immune activation. A critical need exists to develop effective strategies to prevent CVD in this population.MethodsThe Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk. At least 7,500 PWH, 40-75 years of age, on stable antiretroviral therapy, will be randomized to pitavastatin calcium (4 mg/d) or identical placebo and followed for up to 8 years. Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy. Potential participants with a risk score ≤ 15% were eligible based on decreasing LDL-C thresholds for increasing risk score >7.5% (LDL-C 7,500 participants at approximately 120 sites across 11 countries, generating a diverse and representative population of PWH to investigate the primary objective of the trial.ConclusionsREPRIEVE is the first trial investigating a primary CVD prevention strategy in PWH. REPRIEVE will inform the field of the efficacy and safety of a statin strategy among HIV-infected participants on antiretroviral therapy and provide critical information on CVD mechanisms and non-CVD events in PWH.
- Published
- 2019