drugset / Trial / NCT02344290
Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
Phase 3
Completed
7769 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Gilead Sciences · collabKowa Pharmaceuticals America, Inc. · collabMassachusetts General Hospital · collabNEAT ID Foundation · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2015-03-26
- Primary completion
- 2023-08-21
- Completion
- 2023-08-21
Publications
- Background Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-2959. doi: 10.1016/j.jacc.2013.11.005. Epub 2013 Nov 12. No abstract available.
- Results Zanni MV, Fitch K, Rivard C, Sanchez L, Douglas PS, Grinspoon S, Smeaton L, Currier JS, Looby SE. Follow YOUR Heart: development of an evidence-based campaign empowering older women with HIV to participate in a large-scale cardiovascular disease prevention trial. HIV Clin Trials. 2017 Mar;18(2):83-91. doi: 10.1080/15284336.2017.1297551.
- Results Grinspoon SK, Fitch KV, Overton ET, Fichtenbaum CJ, Zanni MV, Aberg JA, Malvestutto C, Lu MT, Currier JS, Sponseller CA, Waclawiw M, Alston-Smith B, Cooper-Arnold K, Klingman KL, Desvigne-Nickens P, Hoffmann U, Ribaudo HJ, Douglas PS; REPRIEVE Investigators. Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE). Am Heart J. 2019 Jun;212:23-35. doi: 10.1016/j.ahj.2018.12.016. Epub 2019 Mar 4.
- Results Hoffmann U, Lu MT, Olalere D, Adami EC, Osborne MT, Ivanov A, Aluru JS, Lee S, Arifovic N, Overton ET, Fichtenbaum CJ, Aberg JA, Alston-Smith B, Klingman KL, Waclawiw M, Burdo TH, Williams KC, Zanni MV, Desvigne-Nickens P, Cooper-Arnold K, Fitch KV, Ribaudo H, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Rationale and design of the Mechanistic Substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE): Effects of pitavastatin on coronary artery disease and inflammatory biomarkers. Am Heart J. 2019 Jun;212:1-12. doi: 10.1016/j.ahj.2019.02.011. Epub 2019 Mar 4.
- Results Grinspoon SK, Douglas PS, Hoffmann U, Ribaudo HJ. Leveraging a Landmark Trial of Primary Cardiovascular Disease Prevention in Human Immunodeficiency Virus: Introduction From the REPRIEVE Coprincipal Investigators. J Infect Dis. 2020 Jul 9;222(Suppl 1):S1-S7. doi: 10.1093/infdis/jiaa098.
- Results Fitch KV, Kileel EM, Looby SE, Zanni MV, Sanchez LR, Fichtenbaum CJ, Overton ET, Malvestutto C, Aberg JA, Klingman KL, Alston-Smith B, Lavelle J, Rancourt A, Badal-Faesen S, Cardoso SW, Avihingsanon A, Patil S, Sponseller CA, Melbourne K, Ribaudo HJ, Cooper-Arnold K, Desvigne-Nickens P, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination. HIV Res Clin Pract. 2020 Feb;21(1):11-23. doi: 10.1080/25787489.2020.1733794. Epub 2020 Mar 11.
- Results Overton ET, Kantor A, Fitch KV, Muntner P, Supparatpinyo K, Mosepele M, Mohapi L, Cardoso SW, Patil S, de Lacerda MVG, McComsey G, Aberg JA, Douglas PS, Grinspoon SK, Ribaudo H, Wyatt CM. An Evaluation of Baseline Kidney Function in the REPRIEVE Trial of Pitavastatin in Human Immunodeficiency Virus. J Infect Dis. 2020 Jul 9;222(Suppl 1):S41-S51. doi: 10.1093/infdis/jiaa222.
- Results Fichtenbaum CJ, Ribaudo HJ, Leon-Cruz J, Overton ET, Zanni MV, Malvestutto CD, Aberg JA, Kileel EM, Fitch KV, Van Schalkwyk M, Kumarasamy N, Martinez E, Santos BR, Joseph Y, Lo J, Siminski S, Melbourne K, Sponseller CA, Desvigne-Nickens P, Bloomfield GS, Currier JS, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Patterns of Antiretroviral Therapy Use and Immunologic Profiles at Enrollment in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S8-S19. doi: 10.1093/infdis/jiaa259.
- Results Smeaton LM, Kileel EM, Grinsztejn B, Gardner EM, Starr K, Murry ML, Desvigne-Nickens P, Alston-Smith B, Waclawiw MA, Cooper-Arnold K, Madruga JV, Sangle S, Fitch KV, Zanni MV, Douglas PS, Ribaudo HJ, Grinspoon SK, Klingman KL. Characteristics of REPRIEVE Trial Participants Identifying Across the Transgender Spectrum. J Infect Dis. 2020 Jul 9;222(Suppl 1):S31-S40. doi: 10.1093/infdis/jiaa213.
- Results Zanni MV, Currier JS, Kantor A, Smeaton L, Rivard C, Taron J, Burdo TH, Badal-Faesen S, Lalloo UG, Pinto JA, Samaneka W, Valencia J, Klingman K, Allston-Smith B, Cooper-Arnold K, Desvigne-Nickens P, Lu MT, Fitch KV, Hoffman U, Grinspoon SK, Douglas PS, Looby SE. Correlates and Timing of Reproductive Aging Transitions in a Global Cohort of Midlife Women With Human Immunodeficiency Virus: Insights From the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S20-S30. doi: 10.1093/infdis/jiaa214.
- Results Neilan TG, Nguyen KL, Zaha VG, Chew KW, Morrison L, Ntusi NAB, Toribio M, Awadalla M, Drobni ZD, Nelson MD, Burdo TH, Van Schalkwyk M, Sax PE, Skiest DJ, Tashima K, Landovitz RJ, Daar E, Wurcel AG, Robbins GK, Bolan RK, Fitch KV, Currier JS, Bloomfield GS, Desvigne-Nickens P, Douglas PS, Hoffmann U, Grinspoon SK, Ribaudo H, Dawson R, Goetz MB, Jain MK, Warner A, Szczepaniak LS, Zanni MV. Myocardial Steatosis Among Antiretroviral Therapy-Treated People With Human Immunodeficiency Virus Participating in the REPRIEVE Trial. J Infect Dis. 2020 Jul 9;222(Suppl 1):S63-S69. doi: 10.1093/infdis/jiaa245.
- Results Douglas PS, Umbleja T, Bloomfield GS, Fichtenbaum CJ, Zanni MV, Overton ET, Fitch KV, Kileel EM, Aberg JA, Currier J, Sponseller CA, Melbourne K, Avihingsanon A, Bustorff F, Estrada V, Ruxrungtham K, Saumoy M, Navar AM, Hoffmann U, Ribaudo HJ, Grinspoon S. Cardiovascular Risk and Health Among People With Human Immunodeficiency Virus (HIV) Eligible for Primary Prevention: Insights From the REPRIEVE Trial. Clin Infect Dis. 2021 Dec 6;73(11):2009-2022. doi: 10.1093/cid/ciab552.
- Results Hoffmann U, Lu MT, Foldyna B, Zanni MV, Karady J, Taron J, Zhai BK, Burdo T, Fitch KV, Kileel EM, Williams K, Fichtenbaum CJ, Overton ET, Malvestutto C, Aberg J, Currier J, Sponseller CA, Melbourne K, Floris-Moore M, Van Dam C, Keefer MC, Koletar SL, Douglas PS, Ribaudo H, Mayrhofer T, Grinspoon SK; REPRIEVE trial. Assessment of Coronary Artery Disease With Computed Tomography Angiography and Inflammatory and Immune Activation Biomarkers Among Adults With HIV Eligible for Primary Cardiovascular Prevention. JAMA Netw Open. 2021 Jun 1;4(6):e2114923. doi: 10.1001/jamanetworkopen.2021.14923.
- Results Kileel EM, Lo J, Malvestutto C, Fitch KV, Zanni MV, Fichtenbaum CJ, Overton ET, Okeke NL, Kumar P, Joao E, Aberg JA, Martinez E, Currier JS, Douglas PS, Ribaudo HJ, Grinspoon SK. Assessment of Obesity and Cardiometabolic Status by Integrase Inhibitor Use in REPRIEVE: A Propensity-Weighted Analysis of a Multinational Primary Cardiovascular Prevention Cohort of People With Human Immunodeficiency Virus. Open Forum Infect Dis. 2021 Nov 20;8(12):ofab537. doi: 10.1093/ofid/ofab537. eCollection 2021 Dec.
- Results Fulda ES, Fitch KV, Overton ET, Zanni MV, Aberg JA, Currier JS, Lu MT, Malvestutto C, Fichtenbaum CJ, Martinez E, Umbleja T, Douglas PS, Ribaudo HJ, Grinspoon SK. COVID-19 Vaccination Rates in a Global HIV Cohort. J Infect Dis. 2022 Feb 15;225(4):603-607. doi: 10.1093/infdis/jiab575.
- Results Bloomfield GS, Weir IR, Ribaudo HJ, Fitch KV, Fichtenbaum CJ, Moran LE, Bedimo R, de Filippi C, Morse CG, Piccini J, Zanni MV, Lu MT, Hoffmann U, Grinspoon SK, Douglas PS. Prevalence and Correlates of Electrocardiographic Abnormalities in Adults With HIV: Insights From the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE). J Acquir Immune Defic Syndr. 2022 Mar 1;89(3):349-359. doi: 10.1097/QAI.0000000000002877.
- Results Erlandson KM, Fitch KV, McCallum SA, Ribaudo HJ, Overton ET, Zanni MV, Bloomfield GS, Brown TT, Fichtenbaum CJ, Bares S, Aberg JA, Douglas PS, Fulda ES, Santana-Bagur JL, Castro JG, Moran LE, Mave V, Supparatpinyo K, Ponatshego PL, Schechter M, Grinspoon SK. Geographical Differences in the Self-Reported Functional Impairment of People With Human Immunodeficiency Virus (HIV) and Associations With Cardiometabolic Risk. Clin Infect Dis. 2022 Sep 30;75(7):1154-1163. doi: 10.1093/cid/ciac098.
- Results Looby SE, Kantor A, Burdo TH, Currier JS, Fichtenbaum CJ, Overton ET, Aberg JA, Malvestutto CD, Bloomfield GS, Erlandson KM, Cespedes M, Kallas EG, Masia M, Thornton AC, Smith MD, Flynn JM, Kileel EM, Fulda E, Fitch KV, Lu MT, Douglas PS, Grinspoon SK, Ribaudo HJ, Zanni MV. Factors Associated With Systemic Immune Activation Indices in a Global Primary Cardiovascular Disease Prevention Cohort of People With Human Immunodeficiency Virus on Antiretroviral Therapy. Clin Infect Dis. 2022 Oct 12;75(8):1324-1333. doi: 10.1093/cid/ciac166.
- Results Overton ET, Weir IR, Zanni MV, Fischinger S, MacArthur RD, Aberg JA, Fitch KV, Frank M, Albrecht H, Goodenough E, Rhame FS, Fichtenbaum CJ, Bloomfield GS, Malvestutto C, Supparatpinyo K, McCallum S, Douglas PS, Alter G, Ribaudo H, Grinspoon SK. Asymptomatic SARS-CoV-2 Infection Is Common Among ART-Treated People With HIV. J Acquir Immune Defic Syndr. 2022 Aug 1;90(4):377-381. doi: 10.1097/QAI.0000000000003000.
- Results Fitch KV, McCallum SA, Erlandson KM, Overton ET, Zanni MV, Fichtenbaum C, Aberg JA, Fulda ES, Kileel EM, Moran LE, Bloomfield GS, Novak RM, Perez-Frontera S, Abrams-Downey A, Pierone G Jr, Kumarasamy N, Ruxrungtham K, Mngqibisa R, Douglas PS, Ribaudo HJ, Grinspoon SK. Diet in a global cohort of adults with HIV at low-to-moderate traditional cardiovascular disease risk. AIDS. 2022 Nov 15;36(14):1997-2003. doi: 10.1097/QAD.0000000000003344. Epub 2022 Jul 27.
- Results Kolossvary M, deFilippi C, Lu MT, Zanni MV, Fulda ES, Foldyna B, Ribaudo H, Mayrhofer T, Collier AC, Bloomfield GS, Fichtenbaum C, Overton ET, Aberg JA, Currier J, Fitch KV, Douglas PS, Grinspoon SK. Proteomic Signature of Subclinical Coronary Artery Disease in People With HIV: Analysis of the REPRIEVE Mechanistic Substudy. J Infect Dis. 2022 Nov 11;226(10):1809-1822. doi: 10.1093/infdis/jiac196.
- Results Zanni MV, Foldyna B, McCallum S, Burdo TH, Looby SE, Fitch KV, Fulda ES, Autissier P, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Overton ET, Aberg JA, Erlandson KM, Campbell TB, Ellsworth GB, Sheth AN, Taiwo B, Currier JS, Hoffmann U, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Sex Differences in Subclinical Atherosclerosis and Systemic Immune Activation/Inflammation Among People With Human Immunodeficiency Virus in the United States. Clin Infect Dis. 2023 Jan 13;76(2):323-334. doi: 10.1093/cid/ciac767.
- Results Schnittman SR, Lu MT, Mayrhofer T, Burdo TH, Fitch KV, McCallum S, Fulda ES, Zanni MV, Foldyna B, Malvestutto C, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Overton ET, Currier J, Tebas P, Sha BE, Ribaudo HJ, Flynn JM, Douglas PS, Erlandson KM, Grinspoon SK. Cytomegalovirus Immunoglobulin G (IgG) Titer and Coronary Artery Disease in People With Human Immunodeficiency Virus (HIV). Clin Infect Dis. 2023 Feb 8;76(3):e613-e621. doi: 10.1093/cid/ciac662.
- Results Douglas PS, McCallum S, Lu MT, Umbleja T, Fitch KV, Foldyna B, Zanni MV, Fulda ES, Bloomfield GS, Fichtenbaum CJ, Overton ET, Aberg JA, Malvestutto CD, Burdo TH, Arduino RC, Ho KS, Yin MT, Ribaudo HJ, Grinspoon SK. Ideal cardiovascular health, biomarkers, and coronary artery disease in persons with HIV. AIDS. 2023 Mar 1;37(3):423-434. doi: 10.1097/QAD.0000000000003418. Epub 2022 Nov 18.
- Results Fulda ES, Fichtenbaum CJ, Kileel EM, Zanni MV, Aberg JA, Malvestutto C, Cardoso SW, Berzins B, Lira R, Harden R, Robbins G, Martinez M, Nieves SD, McCallum S, Cruz JL, Umbleja T, Sprenger H, Giguel F, Bone F, Wood K, Byroads M, Paradis K, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK, Fitch KV; REPRIEVE Investigators. The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial. Contemp Clin Trials. 2023 Jan;124:107035. doi: 10.1016/j.cct.2022.107035. Epub 2022 Nov 30.
- Results Schnittman SR, Jung W, Fitch KV, Zanni MV, McCallum S, Lee JS, Shin S, Davis BJ, Fulda ES, Diggs MR, Giguel F, Chinchay R, Sheth AN, Fichtenbaum CJ, Malvestutto C, Aberg JA, Currier J, Lauffenburger DA, Douglas PS, Ribaudo HJ, Alter G, Grinspoon SK. Effect of host factors and COVID-19 infection on the humoral immune repertoire in treated HIV. JCI Insight. 2023 Mar 8;8(5):e166848. doi: 10.1172/jci.insight.166848.
- Results Kileel EM, Malvestutto CD, Lo J, Fitch KV, Fichtenbaum CJ, Aberg JA, Zanni MV, Martinez E, Okeke NL, Kumar P, Joao E, Bares SH, Berrner D, Smieja M, Roa JC, McCallum S, Douglas PS, Ribaudo HJ, Grinspoon SK. Changes in Body Mass Index with Longer-term Integrase Inhibitor Use: A Longitudinal Analysis of Data from the Randomized Trial to Prevent Vascular Events in Human Immunodeficiency Virus (REPRIEVE). Clin Infect Dis. 2023 Jun 8;76(11):2010-2013. doi: 10.1093/cid/ciad107.
- Results Schnittman SR, Kitch DW, Swartz TH, Burdo TH, Fitch KV, McCallum S, Flynn JM, Fulda ES, Diggs MR, Stapleton JT, Casado JL, Taron J, Currier JS, Zanni MV, Malvestutto C, Fichtenbaum CJ, Aberg JA, Ribaudo HJ, Lu MT, Douglas PS, Grinspoon SK. Coronary Artery Plaque Composition and Severity Relate to the Inflammasome in People With Treated Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Mar 1;10(3):ofad106. doi: 10.1093/ofid/ofad106. eCollection 2023 Mar.
- Results Kolossvary M, deFilippi C, McCallum S, Fitch KV, Diggs MR, Fulda ES, Ribaudo HJ, Fichtenbaum CJ, Aberg JA, Malvestutto CD, Currier JS, Casado JL, Gutierrez F, Sereti I, Douglas PS, Zanni MV, Grinspoon SK. Identification of pre-infection markers and differential plasma protein expression following SARS-CoV-2 infection in people living with HIV. EBioMedicine. 2023 Apr;90:104538. doi: 10.1016/j.ebiom.2023.104538. Epub 2023 Mar 24.
- Results Foldyna B, Mayrhofer T, Zanni MV, Lyass A, Barve R, Karady J, McCallum S, Burdo TH, Fitch KV, Paradis K, Fulda ES, Diggs MR, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Aberg JA, Currier JS, Ribaudo HJ, Hoffmann U, Lu MT, Douglas PS, Grinspoon SK. Pericoronary Adipose Tissue Density, Inflammation, and Subclinical Coronary Artery Disease Among People With HIV in the REPRIEVE Cohort. Clin Infect Dis. 2023 Dec 15;77(12):1676-1686. doi: 10.1093/cid/ciad419.
- Results Grinspoon SK, Fitch KV, Zanni MV, Fichtenbaum CJ, Umbleja T, Aberg JA, Overton ET, Malvestutto CD, Bloomfield GS, Currier JS, Martinez E, Roa JC, Diggs MR, Fulda ES, Paradis K, Wiviott SD, Foldyna B, Looby SE, Desvigne-Nickens P, Alston-Smith B, Leon-Cruz J, McCallum S, Hoffmann U, Lu MT, Ribaudo HJ, Douglas PS; REPRIEVE Investigators. Pitavastatin to Prevent Cardiovascular Disease in HIV Infection. N Engl J Med. 2023 Aug 24;389(8):687-699. doi: 10.1056/NEJMoa2304146. Epub 2023 Jul 23.
- Results Lake JE, Taron J, Ribaudo HJ, Leon-Cruz J, Utay NS, Swaminathan S, Fitch KV, Kileel EM, Paradis K, Fulda ES, Ho KS, Luetkemeyer AF, Johnston CD, Zanni MV, Douglas PS, Grinspoon SK, Lu MT, Fichtenbaum CJ; REPRIEVE Trial Investigators. Hepatic steatosis and nonalcoholic fatty liver disease are common and associated with cardiometabolic risk in a primary prevention cohort of people with HIV. AIDS. 2023 Nov 15;37(14):2149-2159. doi: 10.1097/QAD.0000000000003671. Epub 2023 Jul 27.
- Results Schnittman SR, Kolossvary M, Beck-Engeser G, Fitch KV, Ambayec GC, Nance RM, Zanni MV, Diggs M, Chan F, McCallum S, Toribio M, Bamford L, Fichtenbaum CJ, Eron JJ, Jacobson JM, Mayer KH, Malvestutto C, Bloomfield GS, Moore RD, Umbleja T, Saag MS, Aberg JA, Currier JS, Delaney JAC, Martin JN, Lu MT, Douglas PS, Ribaudo HJ, Crane HM, Hunt PW, Grinspoon SK. Biological and Clinical Implications of the Vascular Endothelial Growth Factor Coreceptor Neuropilin-1 in Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Sep 8;10(10):ofad467. doi: 10.1093/ofid/ofad467. eCollection 2023 Oct.
- Results Bhattacharya R, Uddin MM, Patel AP, Niroula A, Finneran P, Bernardo R, Fitch KV, Lu MT, Bloomfield GS, Malvestutto C, Aberg JA, Fichtenbaum CJ, Hornsby W, Ribaudo HJ, Libby P, Ebert BL, Zanni MV, Douglas PS, Grinspoon SK, Natarajan P. Risk factors for clonal hematopoiesis of indeterminate potential in people with HIV: a report from the REPRIEVE trial. Blood Adv. 2024 Feb 27;8(4):959-967. doi: 10.1182/bloodadvances.2023011324.
- Results Lu MT, Ribaudo H, Foldyna B, Zanni MV, Mayrhofer T, Karady J, Taron J, Fitch KV, McCallum S, Burdo TH, Paradis K, Hedgire SS, Meyersohn NM, DeFilippi C, Malvestutto CD, Sturniolo A, Diggs M, Siminski S, Bloomfield GS, Alston-Smith B, Desvigne-Nickens P, Overton ET, Currier JS, Aberg JA, Fichtenbaum CJ, Hoffmann U, Douglas PS, Grinspoon SK; REPRIEVE Trial Writing Group. Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers in HIV: Mechanistic Substudy of the REPRIEVE Randomized Clinical Trial. JAMA Cardiol. 2024 Apr 1;9(4):323-334. doi: 10.1001/jamacardio.2023.5661.
- Results Zou RS, Ruan Y, Truong B, Bhattacharya R, Lu MT, Karady J, Bernardo R, Finneran P, Hornsby W, Fitch KV, Ribaudo HJ, Zanni MV, Douglas PS, Grinspoon SK, Patel AP, Natarajan P. Polygenic Scores and Preclinical Cardiovascular Disease in Individuals With HIV: Insights From the REPRIEVE Trial. J Am Heart Assoc. 2024 Apr 2;13(7):e033413. doi: 10.1161/JAHA.123.033413. Epub 2024 Mar 27.
- Results Grinspoon SK, Ribaudo HJ, Douglas PS. Trial Update of Pitavastatin to Prevent Cardiovascular Events in HIV Infection. N Engl J Med. 2024 May 2;390(17):1626-1628. doi: 10.1056/NEJMc2400870. No abstract available.
- Grinspoon SK, DeFilippi C, Umbleja T, McCallum S, Christenson RH, Chu SM, Lu AB, Burdo TH, Aberg JA, Fichtenbaum CJ, Bloomfield GS, Malvestutto CD, Currier JS, Lu MT, Zanni MV, Douglas PS, Ribaudo HJ. Inflammatory, Cardiac, and Lipid-Related Biomarkers in Relation to Residual MACE Risk in the REPRIEVE Trial. JACC Adv. 2026 Jul 10;5(8):102984. doi: 10.1016/j.jacadv.2026.102984. Online ahead of print.
- Foldyna B, Hadzic I, Mayrhofer T, Karady J, Taron J, Kolossvary M, Raghu VK, McCallum S, Paradis K, Diggs MR, Chu SM, Lu AB, Somboonwit C, Bernardino JI, Dube MP, Sponseller CA, Zanni MV, Bloomfield GS, Malvestutto CD, Fichtenbaum CJ, Aberg JA, Currier JS, Ribaudo HJ, Douglas PS, Lu MT, Grinspoon SK. Statin Effects on Pericoronary Adipose Tissue Density in People With HIV: Insights From the REPRIEVE Trial. JACC Cardiovasc Imaging. 2026 Apr;19(4):478-489. doi: 10.1016/j.jcmg.2025.10.012. Epub 2025 Dec 1.
- Diggs MR, Chu SM, Fitch KV, Olefsky M, Watanabe MG, Erlandson KM, Lu AB, Bloomfield GS, Currier JS, Curran A, Eckard AR, Smith GHR, Sponseller CA, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Foldyna B, Taron J, Karady J, Zanni MV, Douglas PS, Ribaudo HJ, Lu MT, Grinspoon SK. Health-related quality of life among people with HIV at low-to-moderate risk for atherosclerotic cardiovascular disease in the REPRIEVE Trial. AIDS. 2026 Apr 1;40(4):428-439. doi: 10.1097/QAD.0000000000004401. Epub 2025 Nov 14.
- Xue L, Bhattacharya R, Uddin MM, Nakao T, Zou R, Patel A, Haidermota S, Niroula A, Viscosi V, Postupaka D, Bhatnagar A, Finneran P, Bernardo R, Diggs MR, Fitch KV, Chu SM, McCallum S, Currier JS, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Bloomfield GS, Ribaudo HJ, Zanni MV, Libby P, Hornsby W, Lu MT, Douglas PS, Grinspoon SK, Natarajan P. Clonal Hematopoiesis and Major Adverse Cardiac Events in People With HIV: Insights From the REPRIEVE Trial. Arterioscler Thromb Vasc Biol. 2026 Jan;46(1):168-177. doi: 10.1161/ATVBAHA.125.322896. Epub 2025 Nov 6.
- Grinspoon SK, Zhao S, Martinez E, Fichtenbaum CJ, Chu SM, Diggs MR, Umbleja T, McCallum S, Fitch KV, Triant VA, Currier JS, Aberg JA, Malvestutto CD, Erlandson KM, Bloomfield GS, Lu MT, Douglas PS, Ribaudo HJ, Zanni MV. Risk Assessment in a Global CVD Prevention Cohort of People With HIV by PCE, PREVENT, and SCORE2. Clin Infect Dis. 2026 Feb 25;82(2):e248-e257. doi: 10.1093/cid/ciaf542.
- Kolossvary M, Sereti I, Zanni MV, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Malvestutto CD, Currier JS, Chu SM, Diggs MR, Lu AB, deFilippi C, Foldyna B, McCallum S, Sponseller CA, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Statin-dependent and -independent pathways are associated with major adverse cardiovascular events in people with HIV. J Clin Invest. 2025 Sep 9;135(22):e196021. doi: 10.1172/JCI196021. eCollection 2025 Nov 17.
- Davies Smith E, Douglas PS, McCallum S, Troendle J, Diggs MR, Lu AB, Chu SM, Umbleja T, Lu MT, Zanni MV, Grinspoon SK, Ribaudo HJ. Win Ratio Aligns With and Enhances Interpretation of REPRIEVE's Primary Findings. Clin Infect Dis. 2026 Feb 9;82(1):e89-e92. doi: 10.1093/cid/ciaf477.
- Corley MJ, Watanabe M, Pang APS, Dwaraka VB, Smith R, Samaneka W, Henn S, Munsiff S, Saumoy M, McCallum S, Fitch KV, Chu SM, Diggs MR, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Currier JS, Zanni MV, Douglas PS, Lu MT, Landay AL, Erlandson KM, Ribaudo HJ, Grinspoon SK. Effect of Pitavastatin on Epigenetic Aging Biomarkers in People With HIV: Pilot Substudy of the REPRIEVE Trial. Clin Infect Dis. 2026 Feb 4;81(6):e560-e567. doi: 10.1093/cid/ciaf247.
- Fichtenbaum CJ, Malvestutto CD, Watanabe MG, Davies Smith E, Ribaudo HJ, McCallum S, Fitch KV, Currier JS, Diggs MR, Chu SM, Aberg JA, Lu MT, Valencia J, Gomez-Ayerbe C, Brar I, Valdez Madruga J, Bloomfield GS, Douglas PS, Zanni MV, Grinspoon SK; REPRIEVE Investigators. Effects of antiretrovirals on major adverse cardiovascular events in the REPRIEVE trial: a longitudinal cohort analysis. Lancet HIV. 2025 Jul;12(7):e496-e505. doi: 10.1016/S2352-3018(25)00043-8. Epub 2025 Jun 4.
- Lu MT, Ribaudo HJ, McCallum S, Zanni MV, deFilippi C, Taron J, Karady J, Foldyna B, Paradis K, Chu SM, Diggs MR, Burdo TH, Currier JS, Bloomfield GS, Fichtenbaum CJ, Malvestutto CD, Aberg JA, Mayrhofer T, Douglas PS, Grinspoon SK; REPRIEVE Investigators. Coronary Plaque, Inflammation, Subclinical Myocardial Injury, and Major Adverse Cardiovascular Events in the REPRIEVE Substudy. JACC Adv. 2025 Jun;4(6 Pt 1):101781. doi: 10.1016/j.jacadv.2025.101781. Epub 2025 May 14.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pitavastatin | Small molecule | 4 mg | Oral |