Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults
NCT ID: NCT02344290
Last Updated: 2025-09-04
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
7769 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-03-26
Study Completion Date
2023-08-21
Brief Summary
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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.
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.
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Detailed Description
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There are few strategies to prevent CVD in people with HIV (PWH), even though they are at high risk for developing CVD. Statin medications are used to lower cholesterol and may be effective at reducing the risk of CVD in PWH. The purpose of this study was to evaluate the use of pitavastatin to reduce the risk of CVD in PWH on ART.
This study enrolled PWH who were on any ART regimen (ART was not provided by the study) for at least 6 months before study entry and were at low to moderate risk of CVD using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation.
Participants were randomly assigned to receive 4 mg of pitavastatin or placebo once a day for their entire study duration. Pitavastatin or placebo could be discontinued and clinically indicated statin therapy initiated at the discretion of the site investigator or the participant's care provider, with the intention of following the participant according to the intention-to-treat trial design. Study visits occurred at study entry and Months 1 and 4. Starting at Month 4, study visits occurred every 4 months for the rest of the study. Depending on when participants enrolled, they were in the study for a total of 4 to 8 years. Study visits included medical and medication history reviews, physical examinations, blood collections, assessments and questionnaires, urine collections (for some participants), and an electrocardiogram (ECG) (at study entry only).
Participants at US sites had the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE \[A5333s\]). The substudy evaluated the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in PWH. Participants in the substudy attended study visits at study entry and Months 4 and 24. The visits included questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA). The Mechanistic Substudy closed to accrual on February 6, 2018, when its accrual target of 800 participants had been reached. Sites that enrolled participants into the Mechanistic Substudy are indicated with asterisk (\*) at the end of the institution names in the Contacts and Locations section.
Participants enrolled in REPRIEVE from select study sites, including international sites, through December, 2017, were included in the REPRIEVE Kidney Function Objectives Cohort to evaluate the effects of pitavastatin on parameters of kidney function in the setting of HIV. These objectives include evaluating high risk groups and mechanisms driving kidney function decline in the setting of HIV.
Women and men enrolled in REPRIEVE after February, 2016 were included in an observational cohort (REPRIEVE Women's Objectives Cohort) facilitating assessment of sex-specific mechanisms of CVD risk and risk reduction among PWH. This effort also included an evidence-based recruitment campaign to enhance women's participation in REPRIEVE.
In response to the SARS-CoV-2 pandemic, a supplemental objective was added in 2020. To better understand how COVID-19 affects PWH and if pitavastatin may reduce the risk of serious COVID-19 disease, we evaluated interrelated but independent key topics including epidemiology, host factors, and protective strategies. Starting from April 2020, COVID-19 assessment was completed at each study visit, and blood was collected for COVID-19 biomarkers.
The data and safety monitoring board (DSMB) recommended stopping the trial for efficacy at the second planned review on March 30, 2023, and concluded that no unexpected safety concerns had been reported. Following the DSMB action, participants were asked to return for the final study visit. All final visits were completed by August 21, 2023. We here present the results based on the final trial database, including the full follow-up out to closeout visits.
This study enrolled PWH who were on any ART regimen (ART was not provided by the study) for at least 6 months before study entry and were at low to moderate risk of CVD using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation.
Participants were randomly assigned to receive 4 mg of pitavastatin or placebo once a day for their entire study duration. Pitavastatin or placebo could be discontinued and clinically indicated statin therapy initiated at the discretion of the site investigator or the participant's care provider, with the intention of following the participant according to the intention-to-treat trial design. Study visits occurred at study entry and Months 1 and 4. Starting at Month 4, study visits occurred every 4 months for the rest of the study. Depending on when participants enrolled, they were in the study for a total of 4 to 8 years. Study visits included medical and medication history reviews, physical examinations, blood collections, assessments and questionnaires, urine collections (for some participants), and an electrocardiogram (ECG) (at study entry only).
Participants at US sites had the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE \[A5333s\]). The substudy evaluated the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in PWH. Participants in the substudy attended study visits at study entry and Months 4 and 24. The visits included questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA). The Mechanistic Substudy closed to accrual on February 6, 2018, when its accrual target of 800 participants had been reached. Sites that enrolled participants into the Mechanistic Substudy are indicated with asterisk (\*) at the end of the institution names in the Contacts and Locations section.
Participants enrolled in REPRIEVE from select study sites, including international sites, through December, 2017, were included in the REPRIEVE Kidney Function Objectives Cohort to evaluate the effects of pitavastatin on parameters of kidney function in the setting of HIV. These objectives include evaluating high risk groups and mechanisms driving kidney function decline in the setting of HIV.
Women and men enrolled in REPRIEVE after February, 2016 were included in an observational cohort (REPRIEVE Women's Objectives Cohort) facilitating assessment of sex-specific mechanisms of CVD risk and risk reduction among PWH. This effort also included an evidence-based recruitment campaign to enhance women's participation in REPRIEVE.
In response to the SARS-CoV-2 pandemic, a supplemental objective was added in 2020. To better understand how COVID-19 affects PWH and if pitavastatin may reduce the risk of serious COVID-19 disease, we evaluated interrelated but independent key topics including epidemiology, host factors, and protective strategies. Starting from April 2020, COVID-19 assessment was completed at each study visit, and blood was collected for COVID-19 biomarkers.
The data and safety monitoring board (DSMB) recommended stopping the trial for efficacy at the second planned review on March 30, 2023, and concluded that no unexpected safety concerns had been reported. Following the DSMB action, participants were asked to return for the final study visit. All final visits were completed by August 21, 2023. We here present the results based on the final trial database, including the full follow-up out to closeout visits.
Conditions
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HIV
Cardiovascular Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Pitavastatin
Participants received pitavastatin once a day for the entire time they were in study follow-up.
Group Type
EXPERIMENTAL
Pitavastatin
Intervention Type
DRUG
One tablet (4 mg) taken once daily, orally with or without food
Placebo
Participants received placebo for pitavastatin once a day for the entire time they were in study follow-up.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
One tablet taken once daily, orally with or without food
Interventions
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Pitavastatin
One tablet (4 mg) taken once daily, orally with or without food
Intervention Type
DRUG
Placebo
One tablet taken once daily, orally with or without food
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 10-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
* 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.
* 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
* 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
* 10-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
* 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.
* 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
Minimum Eligible Age
40 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Kowa Pharmaceuticals America, Inc.
INDUSTRY
Sponsor Role
collaborator
Gilead Sciences
INDUSTRY
Sponsor Role
collaborator
Massachusetts General Hospital
OTHER
Sponsor Role
collaborator
NEAT ID Foundation
OTHER
Sponsor Role
collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steven Grinspoon, MD
Role: STUDY_CHAIR
Harvard Medical School (HMS and HSDM)
Locations
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Alabama CRS*
Birmingham, Alabama, United States
Site Status
University of Arizona CRS
Tucson, Arizona, United States
Site Status
University of Southern California CRS*
Los Angeles, California, United States
Site Status
UCLA CARE Center CRS*
Los Angeles, California, United States
Site Status
Mills Clinical Research CRS
Los Angeles, California, United States
Site Status
VA West Los Angeles Medical Center CRS
Los Angeles, California, United States
Site Status
Los Angeles LGBT Center CRS
Los Angeles, California, United States
Site Status
Eisenhower Health Center at Rimrock CRS
Palm Springs, California, United States
Site Status
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States
Site Status
UCSD Antiviral Research Center CRS*
San Diego, California, United States
Site Status
Ucsf Hiv/Aids Crs*
San Francisco, California, United States
Site Status
Harbor-UCLA CRS*
Torrance, California, United States
Site Status
University of Colorado Hospital CRS*
Aurora, Colorado, United States
Site Status
Denver Public Health CRS
Denver, Colorado, United States
Site Status
Yale University CRS
New Haven, Connecticut, United States
Site Status
VA Connecticut Healthcare System CRS
West Haven, Connecticut, United States
Site Status
Whitman-Walker Health CRS
Washington D.C., District of Columbia, United States
Site Status
Georgetown University CRS (GU CRS)
Washington D.C., District of Columbia, United States
Site Status
Capital Medical Associates, PC CRS
Washington D.C., District of Columbia, United States
Site Status
Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS
Washington D.C., District of Columbia, United States
Site Status
Malcom Randall VA Medical Center CRS
Gainesville, Florida, United States
Site Status
AHF-The Kinder Medical Group CRS
Miami, Florida, United States
Site Status
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Miami, Florida, United States
Site Status
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Miami, Florida, United States
Site Status
AHF - South Beach CRS
Miami, Florida, United States
Site Status
Orlando Immunology Center CRS
Orlando, Florida, United States
Site Status
Community AIDS Network/Comprehensive Care Clinic CRS
Sarasota, Florida, United States
Site Status
Florida Department of Health - Hillsborough County
Tampa, Florida, United States
Site Status
AIDS Research and Treatment Center of the Treasure Coast CRS
Vero Beach, Florida, United States
Site Status
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Site Status
Augusta University Research Institute, Inc. CRS
Augusta, Georgia, United States
Site Status
Northwestern University CRS*
Chicago, Illinois, United States
Site Status
Rush University CRS*
Chicago, Illinois, United States
Site Status
UIC Project WISH CRS
Chicago, Illinois, United States
Site Status
Indiana University Infectious Diseases Research CRS
Indianapolis, Indiana, United States
Site Status
Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS
Iowa City, Iowa, United States
Site Status
Bluegrass Care Clinic/University of Kentucky Research Foundation CRS
Lexington, Kentucky, United States
Site Status
550 Clinic -University of Louisville CRS
Louisville, Kentucky, United States
Site Status
Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS
New Orleans, Louisiana, United States
Site Status
Johns Hopkins University CRS*
Baltimore, Maryland, United States
Site Status
Tufts Medical Center CRS
Boston, Massachusetts, United States
Site Status
Massachusetts General Hospital CRS (MGH CRS)*
Boston, Massachusetts, United States
Site Status
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS*
Boston, Massachusetts, United States
Site Status
Boston Medical Center CRS
Boston, Massachusetts, United States
Site Status
Baystate Infectious Diseases Clinical Research CRS
Springfield, Massachusetts, United States
Site Status
Henry Ford Hosp. CRS
Detroit, Michigan, United States
Site Status
St. John Newland Medical Associates CRS
Southfield, Michigan, United States
Site Status
Abbott Northwestern Hospital CRS
Minneapolis, Minnesota, United States
Site Status
University of Mississippi Medical Center CRS
Jackson, Mississippi, United States
Site Status
Washington University Therapeutics (WT) CRS*
St Louis, Missouri, United States
Site Status
Specialty Care Center CRS
Omaha, Nebraska, United States
Site Status
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States
Site Status
New Jersey Medical School Clinical Research Center CRS*
Newark, New Jersey, United States
Site Status
Mount Sinai Beth Israel CRS*
New York, New York, United States
Site Status
VA New York Harbor Healthcare System (NYHHS), NY Campus CRS
New York, New York, United States
Site Status
Weill Cornell Chelsea CRS*
New York, New York, United States
Site Status
Mount Sinai Downtown CRS*
New York, New York, United States
Site Status
Mount Sinai West Samuels CRS*
New York, New York, United States
Site Status
Mount Sinai St. Luke's Morningside CRS*
New York, New York, United States
Site Status
Infectious Disease Clinical and Translational Research Center (CTRC) CRS
New York, New York, United States
Site Status
Columbia P&S CRS*
New York, New York, United States
Site Status
Weill Cornell Uptown CRS*
New York, New York, United States
Site Status
University of Rochester Adult HIV Therapeutic Strategies Network CRS*
Rochester, New York, United States
Site Status
James J Peters VA Medical Center CRS
The Bronx, New York, United States
Site Status
Chapel Hill CRS*
Chapel Hill, North Carolina, United States
Site Status
Duke University Medical Center CRS
Durham, North Carolina, United States
Site Status
Greensboro CRS*
Greensboro, North Carolina, United States
Site Status
Wake Forest Baptist Medical Center CRS
Winston-Salem, North Carolina, United States
Site Status
Cincinnati Clinical Research Site*
Cincinnati, Ohio, United States
Site Status
Case Clinical Research Site*
Cleveland, Ohio, United States
Site Status
Ohio State University CRS*
Columbus, Ohio, United States
Site Status
University of Toledo Medical Center CRS
Toledo, Ohio, United States
Site Status
Oklahoma State University Center for Health Sciences CRS
Tulsa, Oklahoma, United States
Site Status
Division of Infectious Diseases Clinical Research Center- Drexel University CRS
Philadelphia, Pennsylvania, United States
Site Status
Penn Therapeutics, CRS*
Philadelphia, Pennsylvania, United States
Site Status
Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS
Philadelphia, Pennsylvania, United States
Site Status
Positive Health Clinic CRS
Pittsburgh, Pennsylvania, United States
Site Status
University of Pittsburgh CRS*
Pittsburgh, Pennsylvania, United States
Site Status
The Miriam Hospital Clinical Research Site (TMH CRS) CRS*
Providence, Rhode Island, United States
Site Status
Medical University of South Carolina: Division of Infectious Diseases CRS
Charleston, South Carolina, United States
Site Status
Prisma Health CRS
Columbia, South Carolina, United States
Site Status
Vanderbilt Therapeutics (VT) CRS*
Nashville, Tennessee, United States
Site Status
Trinity Health and Wellness Center CRS
Dallas, Texas, United States
Site Status
Dallas VA Medical Center CRS
Dallas, Texas, United States
Site Status
UT Southwestern HIV/ID Clinical Trials Unit CRS
Dallas, Texas, United States
Site Status
Houston AIDS Research Team CRS*
Houston, Texas, United States
Site Status
Michael E. DeBakey VAMC REPRIEVE CRS
Houston, Texas, United States
Site Status
Inova Heart and Vascular Institute CRS
Falls Church, Virginia, United States
Site Status
Virginia Commonwealth University CRS
Richmond, Virginia, United States
Site Status
University of Washington AIDS CRS*
Seattle, Washington, United States
Site Status
Medical College of Wisconsin, Inc. CRS
Milwaukee, Wisconsin, United States
Site Status
Gaborone CRS
Gaborone, South-East District, Botswana
Site Status
Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS
Manaus, Amazonas, Brazil
Site Status
School of Medicine, Federal University of Minas Gerais CRS
Belo Horizonte, Minas Gerais, Brazil
Site Status
HGNI HIV Family Care Clinic - HHFCC CRS
Nova Iguaçu, Rio de Janeiro, Brazil
Site Status
Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
Centro de Referencia e Treinamento DST/AIDS CRS
São Paulo, São Paulo, Brazil
Site Status
Projeto Praça Onze Pesquisa em Saúde CRS
Rio de Janeiro, , Brazil
Site Status
Hospital Federal dos Servidores do Estado CRS
Rio de Janeiro, , Brazil
Site Status
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, , Brazil
Site Status
Instituto de Infectologia Emilio Ribas CRS
São Paulo, , Brazil
Site Status
Centro de Pesquisas Clínicas IC-HCFMUSP CRS
São Paulo, , Brazil
Site Status
Vancouver ID Research & Care Centre Society CRS
Vancouver, British Columbia, Canada
Site Status
Hamilton Health Sciences - Special Immunology Services Clinic CRS
Hamilton, Ontario, Canada
Site Status
Maple Leaf Research CRS
Toronto, Ontario, Canada
Site Status
Toronto General Hospital CRS
Toronto, Ontario, Canada
Site Status
Chronic Viral Illness Service CRS
Montreal, Quebec, Canada
Site Status
Centre hospitalier de l'Université Laval CRS
Québec, Quebec, Canada
Site Status
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
Port-au-Prince, , Haiti
Site Status
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, , Haiti
Site Status
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, India
Site Status
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, India
Site Status
Barranco CRS
Lima, , Peru
Site Status
San Miguel CRS
Lima, , Peru
Site Status
Puerto Rico AIDS Clinical Trials Unit CRS*
San Juan, PR, Puerto Rico
Site Status
Soweto ACTG CRS
Johannesburg, Gauteng, South Africa
Site Status
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Johannesburg, Gauteng, South Africa
Site Status
Durban International Clinical Research Site CRS
Durban, KwaZulu-Natal, South Africa
Site Status
University of Cape Town Lung Institute (UCTLI) CRS
Cape Town, Western Cape, South Africa
Site Status
Famcru Crs
Tygerberg, Western Cape, South Africa
Site Status
Hospital General Universitario de Alicante
Alicante, , Spain
Site Status
Hospital Germans Trias i Pujol
Badalona, , Spain
Site Status
Hospital Universitario Valle d'Hebron
Barcelona, , Spain
Site Status
Hospital Clinic de Barcelona
Barcelona, , Spain
Site Status
Hospital Universitario de Bellvitge
Barcelona, , Spain
Site Status
Hospital Universitario de Basurto de Basurto
Bilbao, , Spain
Site Status
Hospital General Universitario De Elche
Elche, , Spain
Site Status
Hospital Gregorio Universitario Maranon
Madrid, , Spain
Site Status
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Site Status
Hospital Universitario Clinico San Carlos
Madrid, , Spain
Site Status
Hospital Universitario 12 de Octubre
Madrid, , Spain
Site Status
Hospital Universitario La Paz
Madrid, , Spain
Site Status
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Site Status
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Bangkok, , Thailand
Site Status
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, , Thailand
Site Status
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
Kampala, , Uganda
Site Status
Milton Park CRS
Harare, , Zimbabwe
Site Status
Countries
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United States
Botswana
Brazil
Canada
Haiti
India
Peru
Puerto Rico
South Africa
Spain
Thailand
Uganda
Zimbabwe
References
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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RESULT
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.
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RESULT
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.
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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.
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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.
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RESULT
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DERIVED
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DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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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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.
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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.
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Informed Consent Form: English
Document Type: Statistical Analysis Plan: REPRIEVE SAP
Document Type: Statistical Analysis Plan: Mechanistic Substudy SAP
Document Type: Informed Consent Form: Spanish
Related Links
Access external resources that provide additional context or updates about the study.
http://reprievetrial.org/
REPRIEVE Trial Website
https://rsc.niaid.nih.gov/sites/default/files/daids-ae-grading-table-v2-nov2014.pdf
Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
https://database.ich.org/sites/default/files/E2A_Guideline.pdf
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11960
Identifier Type: OTHER
Identifier Source: secondary_id
EU5332
Identifier Type: OTHER
Identifier Source: secondary_id
A5332
Identifier Type: -
Identifier Source: org_study_id
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