NCT02344290

Brief 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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
7,769

participants targeted

Target at P75+ for phase_3 hiv

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_3 hiv

Geographic Reach
13 countries

137 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2015

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 15, 2024

Completed
Last Updated

September 4, 2025

Status Verified

September 1, 2025

Enrollment Period

8.4 years

First QC Date

January 16, 2015

Results QC Date

August 19, 2024

Last Update Submit

September 2, 2025

Conditions

Keywords

HIVCardiovascular DiseaseMyocardial InfarctionInflammationStatinComputerized TomographyCholesterolCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Incidence Rate of Major Adverse Cardiovascular Event (MACE)

    MACE is a composite of cardiovascular (CV) death, myocardial infarction, hospitalization for unstable angina, stroke, transient ischemic attack (TIA), peripheral arterial ischemia, coronary, carotid or peripheral arterial revascularization, or death from an undetermined cause. The incidence rates were estimated based on time to the first event using Poisson distribution, with follow-up time censored at last contact. The treatment effect was estimated via cause-specific relative hazard (i.e. hazard ratio) of prescribed pitavastatin compared to placebo from Cox proportional hazards models, stratified by screening CD4 count and sex. Non-CV deaths (without preceding event of interest) were treated as competing events and censored. Treatment discontinuation was ignored, including the initiation of statin therapy as part of clinical care (intention to treat policy).

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

Secondary Outcomes (34)

  • Incidence Rate of Cardiac Ischemia or Myocardial Infarction

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • Incidence Rate of Cerebrovascular Event (Stroke or TIA)

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • Incidence Rate of Peripheral Arterial Ischemia

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • Incidence Rate of Death From CV Causes

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • Incidence Rate of Death From CV or Undetermined Causes

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • +29 more secondary outcomes

Other Outcomes (2)

  • Incidence Rate of MACE by Sex

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

  • Incidence Rate of MACE by Race

    From entry through end of study. Follow-up time varied depending on time of enrollment (the median follow-up time was 5.6 years).

Study Arms (2)

Pitavastatin

EXPERIMENTAL

Participants received pitavastatin once a day for the entire time they were in study follow-up.

Drug: Pitavastatin

Placebo

PLACEBO COMPARATOR

Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up.

Drug: Placebo

Interventions

One tablet (4 mg) taken once daily, orally with or without food

Pitavastatin

One tablet taken once daily, orally with or without food

Placebo

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (137)

Alabama CRS*

Birmingham, Alabama, 35294, United States

Location

University of Arizona CRS

Tucson, Arizona, 85724, United States

Location

University of Southern California CRS*

Los Angeles, California, 90033-1079, United States

Location

UCLA CARE Center CRS*

Los Angeles, California, 90035, United States

Location

Mills Clinical Research CRS

Los Angeles, California, 90069, United States

Location

VA West Los Angeles Medical Center CRS

Los Angeles, California, 90073, United States

Location

Los Angeles LGBT Center CRS

Los Angeles, California, 90232, United States

Location

Eisenhower Health Center at Rimrock CRS

Palm Springs, California, 92264, United States

Location

Stanford AIDS Clinical Trials Unit CRS

Palo Alto, California, 94304-5350, United States

Location

UCSD Antiviral Research Center CRS*

San Diego, California, 92103, United States

Location

Ucsf Hiv/Aids Crs*

San Francisco, California, 94110, United States

Location

Harbor-UCLA CRS*

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS*

Aurora, Colorado, 80045, United States

Location

Denver Public Health CRS

Denver, Colorado, 80204, United States

Location

Yale University CRS

New Haven, Connecticut, 06510, United States

Location

VA Connecticut Healthcare System CRS

West Haven, Connecticut, 06516, United States

Location

Whitman-Walker Health CRS

Washington D.C., District of Columbia, 20005, United States

Location

Georgetown University CRS (GU CRS)

Washington D.C., District of Columbia, 20007, United States

Location

Capital Medical Associates, PC CRS

Washington D.C., District of Columbia, 20036, United States

Location

Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS

Washington D.C., District of Columbia, 20422, United States

Location

Malcom Randall VA Medical Center CRS

Gainesville, Florida, 32610, United States

Location

AHF-The Kinder Medical Group CRS

Miami, Florida, 33133, United States

Location

The University of Miami AIDS Clinical Research Unit (ACRU) CRS

Miami, Florida, 33136, United States

Location

University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS

Miami, Florida, 33136, United States

Location

AHF - South Beach CRS

Miami, Florida, 33140, United States

Location

Orlando Immunology Center CRS

Orlando, Florida, 32803, United States

Location

Community AIDS Network/Comprehensive Care Clinic CRS

Sarasota, Florida, 34237, United States

Location

Florida Department of Health - Hillsborough County

Tampa, Florida, 33602, United States

Location

AIDS Research and Treatment Center of the Treasure Coast CRS

Vero Beach, Florida, 32960, United States

Location

The Ponce de Leon Center CRS

Atlanta, Georgia, 30308-2012, United States

Location

Augusta University Research Institute, Inc. CRS

Augusta, Georgia, 30912, United States

Location

Northwestern University CRS*

Chicago, Illinois, 60611, United States

Location

Rush University CRS*

Chicago, Illinois, 60612, United States

Location

UIC Project WISH CRS

Chicago, Illinois, 60612, United States

Location

Indiana University Infectious Diseases Research CRS

Indianapolis, Indiana, 46202, United States

Location

Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS

Iowa City, Iowa, 52242, United States

Location

Bluegrass Care Clinic/University of Kentucky Research Foundation CRS

Lexington, Kentucky, 40536, United States

Location

550 Clinic -University of Louisville CRS

Louisville, Kentucky, 40202, United States

Location

Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University CRS*

Baltimore, Maryland, 21205, United States

Location

Tufts Medical Center CRS

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital CRS (MGH CRS)*

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS*

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center CRS

Boston, Massachusetts, 02118, United States

Location

Baystate Infectious Diseases Clinical Research CRS

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hosp. CRS

Detroit, Michigan, 48202, United States

Location

St. John Newland Medical Associates CRS

Southfield, Michigan, 48075, United States

Location

Abbott Northwestern Hospital CRS

Minneapolis, Minnesota, 55407, United States

Location

University of Mississippi Medical Center CRS

Jackson, Mississippi, 39213, United States

Location

Washington University Therapeutics (WT) CRS*

St Louis, Missouri, 63110-1010, United States

Location

Specialty Care Center CRS

Omaha, Nebraska, 68106, United States

Location

Cooper Univ. Hosp. CRS

Camden, New Jersey, 08103, United States

Location

New Jersey Medical School Clinical Research Center CRS*

Newark, New Jersey, 07103, United States

Location

Mount Sinai Beth Israel CRS*

New York, New York, 10003, United States

Location

VA New York Harbor Healthcare System (NYHHS), NY Campus CRS

New York, New York, 10010, United States

Location

Weill Cornell Chelsea CRS*

New York, New York, 10010, United States

Location

Mount Sinai Downtown CRS*

New York, New York, 10011, United States

Location

Mount Sinai West Samuels CRS*

New York, New York, 10019, United States

Location

Mount Sinai St. Luke's Morningside CRS*

New York, New York, 10025, United States

Location

Infectious Disease Clinical and Translational Research Center (CTRC) CRS

New York, New York, 10029, United States

Location

Columbia P&S CRS*

New York, New York, 10032-3732, United States

Location

Weill Cornell Uptown CRS*

New York, New York, 10065, United States

Location

University of Rochester Adult HIV Therapeutic Strategies Network CRS*

Rochester, New York, 14642, United States

Location

James J Peters VA Medical Center CRS

The Bronx, New York, 10468, United States

Location

Chapel Hill CRS*

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center CRS

Durham, North Carolina, 27710, United States

Location

Greensboro CRS*

Greensboro, North Carolina, 27401, United States

Location

Wake Forest Baptist Medical Center CRS

Winston-Salem, North Carolina, 27157, United States

Location

Cincinnati Clinical Research Site*

Cincinnati, Ohio, 45219, United States

Location

Case Clinical Research Site*

Cleveland, Ohio, 44106, United States

Location

Ohio State University CRS*

Columbus, Ohio, 43210, United States

Location

University of Toledo Medical Center CRS

Toledo, Ohio, 43614, United States

Location

Oklahoma State University Center for Health Sciences CRS

Tulsa, Oklahoma, 74127, United States

Location

Division of Infectious Diseases Clinical Research Center- Drexel University CRS

Philadelphia, Pennsylvania, 19102, United States

Location

Penn Therapeutics, CRS*

Philadelphia, Pennsylvania, 19104, United States

Location

Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS

Philadelphia, Pennsylvania, 19140, United States

Location

Positive Health Clinic CRS

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh CRS*

Pittsburgh, Pennsylvania, 15213, United States

Location

The Miriam Hospital Clinical Research Site (TMH CRS) CRS*

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina: Division of Infectious Diseases CRS

Charleston, South Carolina, 29425, United States

Location

Prisma Health CRS

Columbia, South Carolina, 29209, United States

Location

Vanderbilt Therapeutics (VT) CRS*

Nashville, Tennessee, 37204, United States

Location

Trinity Health and Wellness Center CRS

Dallas, Texas, 75208, United States

Location

Dallas VA Medical Center CRS

Dallas, Texas, 75216, United States

Location

UT Southwestern HIV/ID Clinical Trials Unit CRS

Dallas, Texas, 75235-9173, United States

Location

Houston AIDS Research Team CRS*

Houston, Texas, 77030, United States

Location

Michael E. DeBakey VAMC REPRIEVE CRS

Houston, Texas, 77030, United States

Location

Inova Heart and Vascular Institute CRS

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University CRS

Richmond, Virginia, 23298, United States

Location

University of Washington AIDS CRS*

Seattle, Washington, 98104-9929, United States

Location

Medical College of Wisconsin, Inc. CRS

Milwaukee, Wisconsin, 53226, United States

Location

Gaborone CRS

Gaborone, South-East District, Botswana

Location

Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS

Manaus, Amazonas, 69040000, Brazil

Location

School of Medicine, Federal University of Minas Gerais CRS

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

HGNI HIV Family Care Clinic - HHFCC CRS

Nova Iguaçu, Rio de Janeiro, 26030-380, Brazil

Location

Hospital Nossa Senhora da Conceicao CRS

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Centro de Referencia e Treinamento DST/AIDS CRS

SĂ£o Paulo, SĂ£o Paulo, 04121-000, Brazil

Location

Projeto Praça Onze Pesquisa em SaĂºde CRS

Rio de Janeiro, 20020-000, Brazil

Location

Hospital Federal dos Servidores do Estado CRS

Rio de Janeiro, 20221-903, Brazil

Location

Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS

Rio de Janeiro, 21040-360, Brazil

Location

Instituto de Infectologia Emilio Ribas CRS

SĂ£o Paulo, 01246-900, Brazil

Location

Centro de Pesquisas ClĂ­nicas IC-HCFMUSP CRS

SĂ£o Paulo, 05403-010, Brazil

Location

Vancouver ID Research & Care Centre Society CRS

Vancouver, British Columbia, V6Z 2C7, Canada

Location

Hamilton Health Sciences - Special Immunology Services Clinic CRS

Hamilton, Ontario, L8S 1A4, Canada

Location

Maple Leaf Research CRS

Toronto, Ontario, M5G 1K2, Canada

Location

Toronto General Hospital CRS

Toronto, Ontario, M5G 2N2, Canada

Location

Chronic Viral Illness Service CRS

Montreal, Quebec, H4A 3J1, Canada

Location

Centre hospitalier de l'Université Laval CRS

Québec, Quebec, G1V 4G2, Canada

Location

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS

Port-au-Prince, HT-6110, Haiti

Location

Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS

Port-au-Prince, HT-6110, Haiti

Location

Byramjee Jeejeebhoy Medical College (BJMC) CRS

Pune, Maharashtra, 411001, India

Location

Chennai Antiviral Research and Treatment (CART) CRS

Chennai, Tamil Nadu, 600113, India

Location

Barranco CRS

Lima, 15063, Peru

Location

San Miguel CRS

Lima, 32 - 15088, Peru

Location

Puerto Rico AIDS Clinical Trials Unit CRS*

San Juan, PR, 00935, Puerto Rico

Location

Soweto ACTG CRS

Johannesburg, Gauteng, 1862, South Africa

Location

Wits Helen Joseph Hospital CRS (Wits HJH CRS)

Johannesburg, Gauteng, 2092, South Africa

Location

Durban International Clinical Research Site CRS

Durban, KwaZulu-Natal, 4052, South Africa

Location

University of Cape Town Lung Institute (UCTLI) CRS

Cape Town, Western Cape, 7700, South Africa

Location

Famcru Crs

Tygerberg, Western Cape, 7505, South Africa

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Germans Trias i Pujol

Badalona, 080916, Spain

Location

Hospital Universitario Valle d'Hebron

Barcelona, 08003, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario de Basurto de Basurto

Bilbao, 48013, Spain

Location

Hospital General Universitario De Elche

Elche, 03203, Spain

Location

Hospital Gregorio Universitario Maranon

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de la Victoria

MĂ¡laga, 29010, Spain

Location

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS

Bangkok, 10330, Thailand

Location

Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS

Chiang Mai, 50200, Thailand

Location

Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site

Kampala, Uganda

Location

Milton Park CRS

Harare, Zimbabwe

Location

Related Publications (57)

  • 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.

    PMID: 24239921BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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. 2025 Nov 24:S1936-878X(25)00594-7. doi: 10.1016/j.jcmg.2025.10.012. Online ahead of print.

  • 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. 2025 Nov 10. doi: 10.1097/QAD.0000000000004401. Online ahead of print.

  • 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. 2025 Sep 26:ciaf542. doi: 10.1093/cid/ciaf542. Online ahead of print.

  • 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.

  • 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. 2025 Jun 18:ciaf247. doi: 10.1093/cid/ciaf247. Online ahead of print.

  • 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.

  • Grinspoon SK, Watanabe M, Ribaudo HJ, Bloomfield GS, Fichtenbaum CJ, Umbleja T, Chu SM, Fitch KV, Diggs MR, Zhao S, Looby SE, Currier JS, Aberg JA, Malvestutto CD, Erlandson KM, Martinez E, Asupoto O, Gupta SK, Lopez-Bernaldo de Quiros JC, Nixon D, Bedimo R, Lu MT, Douglas PS, Zanni MV. Factors Affecting Risk of Cardiovascular Disease (CVD) Events in a Global CVD Prevention Cohort of People With HIV. Clin Infect Dis. 2026 Feb 4;81(6):e548-e557. doi: 10.1093/cid/ciaf210.

  • Davies Smith E, Malvestutto C, Ribaudo HJ, Fichtenbaum CJ, Aberg JA, Watanabe M, Bloomfield GS, Currier JS, Chu SM, Fitch KV, Diggs MR, Bedimo R, Valencia J, Gomez-Ayerbe C, Brar I, Madruga JV, Lu MT, Douglas PS, Zanni MV, Grinspoon SK. Cardiovascular Hazards of Abacavir- Versus Tenofovir-Containing Antiretroviral Therapies: Insights From an Analysis of the REPRIEVE Trial Cohort. Open Forum Infect Dis. 2025 Mar 21;12(4):ofaf177. doi: 10.1093/ofid/ofaf177. eCollection 2025 Apr.

  • Diggs MR, Umbleja T, McCallum S, Zanni MV, Chu SM, Fitch KV, Bloomfield GS, Currier JS, Martinez E, Castle PE, Awwad A, Jain MK, Bedimo R, Hendricks B, Narrea J, Estrada V, Pinto J, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Statin effects on the incidence of major non-cardiovascular disease events among a global cohort of people with HIV: a randomised controlled trial. Lancet HIV. 2025 Apr;12(4):e261-e272. doi: 10.1016/S2352-3018(24)00345-X.

  • Grinspoon SK, Zanni MV, Triant VA, Kantor A, Umbleja T, Diggs MR, Chu SM, Fitch KV, Currier JS, Bloomfield GS, Casado JL, de la Pena M, Fantry LE, Gardner E, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Ribaudo HJ, Douglas PS. Performance of the pooled cohort equations and D:A:D risk scores among individuals with HIV in a global cardiovascular disease prevention trial: a cohort study leveraging data from REPRIEVE. Lancet HIV. 2025 Feb;12(2):e118-e129. doi: 10.1016/S2352-3018(24)00276-5. Epub 2025 Jan 17.

  • Kolossvary M, Schnittman SR, Zanni MV, Fitch KV, Fichtenbaum CJ, Aberg JA, Bloomfield GS, Malvestutto CD, Currier J, Diggs MR, deFilippi C, Eckard AR, Curran A, Centinbas M, Sadreyev R, Foldyna B, Mayrhofer T, Karady J, Taron J, McCallum S, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV: A Secondary Analysis of the REPRIEVE Randomized Clinical Trial. JAMA Cardiol. 2025 Mar 1;10(3):254-264. doi: 10.1001/jamacardio.2024.4115.

  • Zanni MV, Umbleja T, Fichtenbaum CJ, Fitch KV, McCallum S, Aberg JA, Overton ET, Malvestutto CD, Bloomfield GS, Currier JS, Schnittman SR, Erlandson KM, Diggs MR, Foldyna B, Martinez E, Somboonwit C, Wang GP, Mushatt D, Connick E, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Effects of Pitavastatin on COVID-19 Incidence and Seriousness Among a Global Cohort of People With HIV. Open Forum Infect Dis. 2024 Oct 10;11(10):ofae574. doi: 10.1093/ofid/ofae574. eCollection 2024 Oct.

  • Fitch KV, Zanni MV, Manne-Goehler J, Diggs MR, Gattu AK, Currier JS, Bloomfield GS, Hsiao CB, Gupta SK, Aberg JA, Malvestutto CD, Fichtenbaum CJ, Lu MT, Douglas PS, Ribaudo HJ, Grinspoon SK. Diabetes Risk Factors in People With HIV Receiving Pitavastatin Versus Placebo for Cardiovascular Disease Prevention : A Randomized Trial. Ann Intern Med. 2024 Nov;177(11):1449-1461. doi: 10.7326/ANNALS-24-00944. Epub 2024 Oct 8.

  • deFilippi C, McCallum S, Zanni MV, Fitch KV, Diggs MR, Bloomfield GS, Fichtenbaum CJ, Aberg JA, Malvestutto CD, Pinto-Martinez A, Stapleton A, Duggan J, Robbins GK, Taron J, Karady J, Foldyna B, Lu MT, Ribaudo HJ, Douglas PS, Grinspoon SK. Association of Cardiac Troponin T With Coronary Atherosclerosis in Asymptomatic Primary Prevention People With HIV. JACC Adv. 2024 Aug 16;3(9):101206. doi: 10.1016/j.jacadv.2024.101206. eCollection 2024 Sep.

  • Erlandson KM, Umbleja T, Ribaudo HJ, Schrack JA, Overton ET, Fichtenbaum CJ, Fitch KV, Roa JC, Diggs MR, Wood K, Zanni MV, Bloomfield GS, Malvestutto C, Aberg JA, Rodriguez-Barradas MC, Morones RG, Breaux K, Douglas PS, Grinspoon SK, Brown TT. Pitavastatin Is Well-Tolerated With no Detrimental Effects on Physical Function. Clin Infect Dis. 2025 Feb 24;80(2):425-433. doi: 10.1093/cid/ciae422.

  • Abidi MZ, Umbleja T, Overton ET, Burdo T, Flynn JM, Lu MT, Taron J, Schnittman SR, Fitch KV, Zanni MV, Fichtenbaum CJ, Malvestutto C, Aberg JA, Fulda ES, Eckard AR, Manne-Goehler J, Tuan JJ, Ribaudo HJ, Douglas PS, Grinspoon SK, Brown TT, Erlandson KM. Cytomegalovirus IgG is Associated With Physical Function But Not Muscle Density in People With HIV. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):470-478. doi: 10.1097/QAI.0000000000003377.

  • Erlandson KM, Umbleja T, Lu MT, Taron J, Ribaudo HJ, Overton ET, Presti RM, Haas DW, Sax PE, Yin MT, Zhai BK, Louis R, Upadhyay N, Eslami P, Douglas PS, Zanni MV, Fitch KV, Fulda ES, Fichtenbaum CJ, Malvestutto CD, Grinspoon SK, Brown TT. Associations of Muscle Density and Area With Coronary Artery Plaque and Physical Function. J Acquir Immune Defic Syndr. 2023 Oct 1;94(2):174-184. doi: 10.1097/QAI.0000000000003244.

  • Umbleja T, Brown TT, Overton ET, Ribaudo HJ, Schrack JA, Fitch KV, Douglas PS, Grinspoon SK, Henn S, Arduino RC, Rodriguez B, Benson CA, Erlandson KM. Physical Function Impairment and Frailty in Middle-Aged People Living With Human Immunodeficiency Virus in the REPRIEVE Trial Ancillary Study PREPARE. J Infect Dis. 2020 Jul 9;222(Suppl 1):S52-S62. doi: 10.1093/infdis/jiaa249.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionInflammationCOVID-19

Interventions

pitavastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
REPRIEVE Project Manager
Organization
REPRIEVE Clinical Coordinating Center

Study Officials

  • Steven Grinspoon, MD

    Harvard Medical School (HMS and HSDM)

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2015

First Posted

January 22, 2015

Study Start

March 26, 2015

Primary Completion

August 21, 2023

Study Completion

August 21, 2023

Last Updated

September 4, 2025

Results First Posted

October 15, 2024

Record last verified: 2025-09

Locations