Clinical Trial Details

NCT ID: NCT02344290
Date Last Changed: September 5, 2017


Research Study Summary

A Phase 4 clinical study for patients with HIV Infections or Cardiovascular Diseases

Research Study Title

Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE


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).

To Learn more

Recruitment Details

40 to 75 Years
Overall Status
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
61 Months
Facility Type


All ages 40 Years to 75 Years

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 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

Exclusion Criteria:

  • 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 12 months prior to study entry. NOTE: Subjects with successfully treated non-melanomatous skin cancer within 12 months prior to study entry are acceptable. Disseminated Kaposi Sarcoma (visceral organ involvement) within the past 12 months is exclusionary.

  • 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 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

Site Locations (124)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35294 Alabama CRS
Edgar T. Overton, M.D.
United States Arizona Tucson 85724 University of Arizona CRS
Martha L. Barrón
United States California Los Angeles 90033-1079 University of Southern California CRS
Luis M. Mendez
United States California Los Angeles 90035 UCLA CARE Center CRS
Arezou S. Akha, M.D., M.S.
United States California Los Angeles 90069 Mills Clinical Research CRS
Sandro Antunes
United States California Los Angeles 90073 VA West Los Angeles Medical Center CRS
Wendy Rossen, R.N.
310-478-3711 ext. 48136
United States California Los Angeles 90232 Los Angeles LGBT Center CRS
Risa Flynn
United States California Palm Springs 92264 Eisenhower Health Center at Rimrock CRS
Stephanie Farrell, B.S.N., M.B.A., R.N.
United States California Palo Alto 94304-5350 Stanford AIDS Clinical Trials Unit CRS
Philip M. Grant, M.D.
United States California San Diego 92103 UCSD Antiviral Research Center CRS
Jill Kunkel, R.N.
United States California San Francisco 94110 Ucsf Hiv/Aids Crs
Jay Dwyer
415-476-4082 ext. 353
United States California Torrance 90502 Harbor-UCLA CRS
Mario Guerrero
424-201-3000 ext. 7318
United States Colorado Aurora 80045 University of Colorado Hospital CRS
Mary Graham Ray, R.N., M.S.N.
United States Colorado Denver 80204 Denver Public Health CRS
James A. Scott, A.C.R.N., B.S.N.
United States Connecticut New Haven 06510 Yale University CRS
Laurie Andrews, R.N., M.P.H.
United States Connecticut West Haven 06516 VA Connecticut Healthcare System CRS
Laurie Andrews, R.N., M.P.H.
United States District of Columbia Washington, D.C. 20005 Whitman-Walker Health CRS
Anna Wimpelberg, B.A.
United States District of Columbia Washington, D.C. 20007 Georgetown University CRS (GU CRS)
Cathy Kangale-Whitney, R.N.
United States District of Columbia Washington, D.C. 20036 Capital Medical Associates, PC CRS
Kenneth Granville, CCRC
United States Florida Gainesville 32610 Malcom Randall VA Medical Center CRS
Evan Waters
United States Florida Gainesville 32610 University of Florida Clinical Research Center CRS
Evan Waters
United States Florida Miami 33133 AHF-The Kinder Medical Group CRS
Michele Manrique
786-497-4000 ext. 3063
United States Florida Miami 33136 The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Hancy Brignol, B.S.N., M.H.S.A.
United States Florida Miami 33136 University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Kenia Moreno, CRC
United States Florida Miami 33140 AHF - South Beach CRS
Emily Ruiz
305-538-1400 ext. 2520
United States Florida Orlando 32803 Orlando Immunology Center CRS
Jeffrey Dinsmore, R.N., A.C.R.N., C.C.R.C.
United States Florida Orlando 32805 Sunshine Care Center CRS
Willie M. Carter, M.P.H., CRC
United States Florida Sarasota 34237 Community AIDS Network/Comprehensive Care Clinic CRS
Angela Ristuccia
941-366-0134 ext. 1022
United States Florida Tampa 33602 Florida Department of Health - Hillsborough County
Irene Chen, M.A.
813-307-8015 ext. 8067
United States Florida Vero Beach 32960 AIDS Research and Treatment Center of the Treasure Coast CRS
Mona White, L.P.N.
United States Georgia Atlanta 30308-2012 The Ponce de Leon Center CRS
Ericka Patrick, M.S.N.
United States Georgia Augusta 30912 Augusta University Research Institute, Inc. CRS
Martha (Marti) Farrough, B.S.N., R.N.
United States Illinois Chicago 60611 Northwestern University CRS
Baiba Berzins, M.P.H.
United States Illinois Chicago 60612 Rush University CRS
Antoinette Lewis
United States Illinois Chicago 60612 UIC Project WISH CRS
Regina Harden, B.A.
United States Indiana Indianapolis 46202 Indiana University Infectious Diseases Research CRS
Patricia Anderson
United States Iowa Iowa City 52242 Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS
Wendy Sauter, B.S., B.S.N.
United States Kentucky Lexington 40536 Bluegrass Care Clinic/University of Kentucky Research Foundation CRS
Ryan M. Weeks
United States Kentucky Louisville 40202 550 Clinic -University of Louisville CRS
Andrea Reyes Vega
United States Louisiana New Orleans 70112 Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS
Suzanne Adams, R.N.
United States Maryland Baltimore 21201 University of Maryland Baltimore, Institute of Human Virology CRS
Amy Nelson, R.N., CCRP
United States Maryland Baltimore 21205 Johns Hopkins University CRS
Ilene Wiggins, R.N.
United States Massachusetts Boston 02111 Tufts Medical Center CRS
Deirdre Burke
United States Massachusetts Boston 02114 Massachusetts General Hospital CRS (MGH CRS)
Theresa Flynn, R.N., M.S.N., A.N.P., B.S.N.
United States Massachusetts Boston 02115 Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Cheryl E. Keenan, R.N.
United States Massachusetts Boston 02118 Boston Medical Center CRS
Julianne Steinberg, R.N.
United States Massachusetts Springfield 01199 Baystate Infectious Diseases Clinical Research CRS
Frances Santiago, R.N., CCRP
United States Michigan Detroit 48202 Henry Ford Hosp. CRS
Linda Makohon, R.N., B.S.N.
United States Minnesota Minneapolis 55407 Abbott Northwestern Hospital CRS
Adrienne Baranauskas, R.N.
United States Mississippi Jackson 39213 University of Mississippi Medical Center CRS
Jennifer K. Brumfield, R.N., M.H.S.
United States Missouri Saint Louis 63110-1010 Washington University Therapeutics (WT) CRS
Michael K. Klebert
United States Missouri Saint Louis 63139 Southampton Healthcare, Inc. CRS
Shineeka Smith, B.S.
314-647-2200 ext. 116
United States Nebraska Omaha 68106 Specialty Care Center CRS
Maureen Kubat, B.S.N., R.N.
United States New Jersey Camden 08103 Cooper Univ. Hosp. CRS
Patricia Coburn, R.N., B.S.N., CCRC
United States New Jersey Newark 07103 New Jersey Medical School Clinical Research Center CRS
Baljinder Singh
United States New York Brooklyn 11209 VA New York Harbor Healthcare System (NYHHS), Brooklyn Campus CRS
Christine Reel-Brander, R.N.
718-836-6600 ext. 6037
United States New York New York 10003 Mount Sinai Beth Israel CRS
Sondra Middleton, P.A. -C
United States New York New York 10010 VA New York Harbor Healthcare System (NYHHS), NY Campus CRS
Christine Reel-Brander, R.N.
718-836-6600 ext. 6037
United States New York New York 10010 Weill Cornell Chelsea CRS
Todd Stroberg, R.N., B.S.N.
United States New York New York 10011 Mount Sinai Downtown CRS
Helen M. Seedhom, R.N., B.S.N.
United States New York New York 10019 Mount Sinai West Samuels CRS
Janet Forcht, R.N.
United States New York New York 10025 Mount Sinai St. Luke's Morningside CRS
Janet Forcht, R.N.
United States New York New York 10029 Infectious Disease Clinical and Translational Research Center (CTRC) CRS
Karen Cavanagh, R.N.
United States New York New York 10032-3732 Columbia P&S CRS
Jolene Noel-Connor, RN
United States New York New York 10065 Weill Cornell Uptown CRS
Louise Walshe
United States New York Rochester 14642 University of Rochester Adult HIV Therapeutic Strategies Network CRS
Mary Adams
United States New York The Bronx 10468 James J Peters VA Medical Center CRS
Johane Simelane
718-584-9000 ext. 6671
United States North Carolina Chapel Hill 27599 Chapel Hill CRS
Susan Pedersen
United States North Carolina Durham 27710 Duke University Medical Center CRS
Emily Hecker
United States North Carolina Greensboro 27401 Greensboro CRS
Kim Epperson, R.N., B.S.N., CRC
United States North Carolina Winston-Salem 27157 Wake Forest Baptist Medical Center CRS
Katherine Strand
United States Ohio Cincinnati 45219 Cincinnati Clinical Research Site
Sharon Kohrs, R.N., B.S.N.
United States Ohio Cleveland 44106 Case Clinical Research Site
Jane Baum, R.N.
United States Ohio Columbus 43210 Ohio State University CRS
Kathy Watson, B.S.N.
United States Ohio Toledo 43614 University of Toledo Medical Center CRS
Nicole Amadio, R.N.
United States Oklahoma Tulsa 74127 Oklahoma State University Center for Health Sciences CRS
Sherrita Sweet, M.H.A.
United States Pennsylvania Philadelphia 19102 Division of Infectious Diseases Clinical Research Center- Drexel University CRS
Theresa Linus, R.N., B.S.N.
United States Pennsylvania Philadelphia 19104 Penn Therapeutics, CRS
Eileen B. Donaghy, C.R.N.P.
United States Pennsylvania Philadelphia 19140 Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS
James Robinson, M.S.W., M.P.H.
United States Pennsylvania Pittsburgh 15212 Positive Health Clinic CRS
Megan Finnerty
United States Pennsylvania Pittsburgh 15213 University of Pittsburgh CRS
Patricia Peters, R.Ph.
United States Rhode Island Providence 02906 The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Pamela Poethke, R.N.
United States South Carolina Charleston 29425 Medical University of South Carolina: Division of Infectious Diseases CRS
Tamara D. Jenkins, M.A.
United States South Carolina Columbia 29209 Palmetto Health Clinical Trial Department CRS
Julia M. Adams
United States Tennessee Nashville 37204 Vanderbilt Therapeutics (VT) CRS
Beverly O. Woodward, M.S.N., R.N.
United States Texas Dallas 75208 Trinity Health and Wellness Center CRS
Lauren Rogers, CCRC
United States Texas Dallas 75216 Dallas VA Medical Center CRS
Teagan Lampkin, B.A.
United States Texas Dallas 75235-9173 UT Southwestern HIV/ID Clinical Trials Unit CRS
Tianna Petersen, M.S.
United States Texas Houston 77030 Houston AIDS Research Team CRS
Maria L. Martinez
United States Texas Houston 77030 Michael E. DeBakey VAMC REPRIEVE CRS
Mahwish Mushtaq, M.D., M.P.H.
713-791-1414 ext. 2558
United States Virginia Falls Church 22042 Inova Heart and Vascular Institute CRS
Jane Lettmann, R.N., C.C.R.C.
United States Virginia Richmond 23298 Virginia Commonwealth University CRS
Vicky Watson
United States Washington Seattle 98104-9929 University of Washington AIDS CRS
Christine Jonsson
United States Wisconsin Milwaukee 53226 Medical College of Wisconsin, Inc. CRS
Sonija Parker, B.S., C.C.R.C.
Botswana South-East District Gaborone Gaborone CRS
Tebogo J. Kakhu
Brazil Amazonas Manaus 69040000 Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS
Kim V. Amaral Machado, R.N., M.Sc.
Brazil Minas Gerais Belo Horizonte 30130-100 School of Medicine, Federal University of Minas Gerais CRS
Laura V. Costa
Brazil Rio de Janeiro Nova Iguacu 26030-380 HGNI HIV Family Care Clinic - HHFCC CRS
Flavio P. Bustorff, M.D.
Brazil Rio Grande do Sul Porto Alegre 91350-200 Hospital Nossa Senhora da Conceicao CRS
Rita d. Lira, M.D.
Brazil São Paulo Sao Paulo 04121-000 Centro de Referencia e Treinamento DST/AIDS CRS
Priscilla de Lima e Menezes, R.N.
Brazil Rio de Janeiro 20020-000 Projeto Praça Onze Pesquisa em Saúde CRS
Carina B. Yoshida, R.N.
Brazil Rio de Janeiro 20221-903 Hospital Federal dos Servidores do Estado CRS
Jacqueline A. de Menezes, M.D
Brazil Rio de Janeiro 21040-360 Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Sandra W. Cardoso, Ph.D., M.D.
Brazil Sao Paulo 01246-900 Instituto de Infectologia Emilio Ribas CRS
Ricardo A. Braga
Brazil Sao Paulo 05403-000 Centro de Pesquisas Clínicas IC-HCFMUSP CRS
Zelinda M. Nakagawa, M.Sc.
Canada British Columbia Vancouver V6Z 2C7 Vancouver ID Research & Care Centre Society CRS
Victor Chiang
Canada Ontario Hamilton L8S 1A4 Hamilton Health Sciences - Special Immunology Services Clinic CRS
Laura Puri
905-521-2100 ext. 73538
Canada Ontario Toronto M5G 1K2 Maple Leaf Research CRS
Roberta Halpenny, M.Sc., CCRP
Canada Ontario Toronto M5G 2N2 Toronto General Hospital CRS
Rosemarie J. Clarke, R.N.
416-340-4800 ext. 6723
Canada Quebec Montreal H2L 4P9 Clinique Medicale L'Actuel CRS
Tevy-Suzy Tep
Canada Quebec Montreal H4A 3J1 Chronic Viral Illness Service CRS
Rhyan Pineda
514-934-1934 ext. 32538
Canada Quebec Quebec City G1V 4G2 Centre hospitalier de l'Université Laval CRS
Isabelle Chabot
1-418-525-4444 ext. 47778
India Maharashtra Pune 411001 Byramjee Jeejeebhoy Medical College (BJMC) CRS
Nishi Suryavanshi, Ph.D.
India Tamil Nadu Chennai 600113 Chennai Antiviral Research and Treatment (CART) CRS
Faith E. Samson
Peru Lima 04 - 15063 Barranco CRS
Fanny Rosas, R.N.
51-1-2067800 ext. Ext. 401
Peru Lima 32 - 15088 San Miguel CRS
Carla J. Porcile, R.N.
51-1-5621600 ext. Ext. 644
Puerto Rico San Juan 00935 Puerto Rico AIDS Clinical Trials Unit CRS
Sylvia I. Davila Nieves, M.Sc.
South Africa Gauteng Johannesburg 1862 Soweto ACTG CRS
Debra Peters
27-119899700 ext. 915
South Africa Gauteng Johannesburg 2092 Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Anne Reyneke
South Africa Kwa Zulu Natal Durban 4007 Durban International Clinical Research Site CRS
Rosie Mngqibisa, MB ChB, M.B.B.S.
South Africa Western Cape Province Cape Town 7700 University of Cape Town Lung Institute (UCTLI) CRS
Gidea Conradie, Ph.D.
South Africa Western Cape Province Tygerberg 7505 Fam-Cru Crs
Joan Coetzee
Thailand Bangkok 10330 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Parawee Thongpaeng
662-6523040 ext. 106
Thailand Chiang Mai 50200 Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Daralak Tavornprasit, R.N., M.Sc.


Kathleen Fitch, ANP

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