Clinical Trials

MainTitle

Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults (REPRIEVE)

This study is ongoing, but not recruiting participants.
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Kowa Pharmaceuticals America, Inc.
Gilead Sciences
Massachusetts General Hospital (MGH)
NEAT ID

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT02344290

First received: January 16, 2015
Last updated: February 4, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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).

The REPRIEVE trial consists of two parallel identical protocols:

  • REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided by the NIAID, and is conducted in U.S and select international sites (approximately 120 sites in 11 countries).
  • REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in
Spain.

Condition Intervention Phase
HIV Infections
Cardiovascular Diseases

Drug : Pitavastatin
Drug : Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Time to the first event of a composite of major cardiovascular events [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
    Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary or peripheral arterial revascularization, nonfatal stroke or transient ischemic attack (TIA), urgent peripheral arterial disease (PAD) ischemic event (acute or chronic limb ischemia, amputation, etc.)
Secondary Outcome Measures:
  • Time to the first of each individual component of the primary endpoint [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
    Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary or peripheral arterial revascularization, nonfatal stroke or TIA, urgent PAD ischemic event (acute or chronic limb ischemia, amputation, etc.)
  • Time to death (all-cause mortality) [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
  • Time to death (all-cause mortality) and/or major adverse cardiovascular events (MACE) [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
  • Time to any (composite) or each (individual) of the following clinical diagnoses (including recurrent diagnoses as appropriate) [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
    Non AIDS-defining cancers (excluding basal cell and squamous cell carcinomas of the skin); AIDS-defining events (based on Centers for Disease Control and Prevention [CDC] 2014 classification); initiation of dialysis or renal transplantation; cirrhosis, or hepatic decompensation requiring hospitalization.
  • Calculated fasting low-density lipoprotein (LDL) and non-high-density lipoprotein (HDL) cholesterol level [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
    Change from baseline expressed as absolute change and as a percentage of baseline. For participants with triglycerides greater than 400 mg/dL and less than 500 mg/dL, direct LDL will be determined and used in the statistical analysis.
  • Time to any of the following adverse events (including recurrent events as appropriate) [ Time Frame: Measured through participants' final study visit, at approximately Month 36 to 96 ]
    Serious adverse event as defined by International Conference on Harmonisation (ICH) criteria, incident diabetes mellitus (DM), grade 3 or 4 ALT, or grade 3 or 4 myopathy.
  • For substudy: evidence of non-calcified coronary atherosclerotic plaque (NCP) [ Time Frame: Measured through Year 2 ]
  • For substudy: volume of NCP at study entry and change in NCP over 2 years [ Time Frame: Measured through Year 2 ]
    Expressed as absolute change and as a percentage of baseline.
  • For substudy: progression of NCP [ Time Frame: Measured through Year 2 ]
    Participants with evidence of NCP at entry: any progression/increase in NCP volume; participants without evidence of NCP at entry, incident NCP.
  • For substudy: number of high risk plaque features [ Time Frame: Measured through Year 2 ]
    Low Hounsfield Unit attenuation by CT assessment; positive remodeling.
  • For substudy: changes in inflammatory markers [ Time Frame: Measured through Year 2 ]
    Expressed as change in CRP, Lp-PLA2, sCD163
  • For substudy: changes in markers of glucose homeostasis [ Time Frame: Measured through Year 2 ]
    Expressed as change in hemoglobin A1C

Enrollment: 7770
Study Start Date: March 26, 2015
Estimated Study Completion Date: March 26, 2023
Estimated Primary Completion Date: March 24, 2023 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Pitavastatin
Participants will receive pitavastatin once a day for the entire time they are enrolled in the study.
Drug: Pitavastatin

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

Placebo Comparator: Placebo
Participants will receive placebo for pitavastatin once a day for the entire time they are enrolled in the study.
Drug: Placebo

One tablet taken once daily, orally with or without food

Detailed Description:

Currently, there are few strategies to prevent CVD in HIV-infected people, 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 people infected with HIV. The purpose of this study is to evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on ART.
This study will enroll adults infected with HIV who are on any ART regimen (ART is not provided by the study) for at least 6 months before study entry considered low-to-moderate risk using the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) guideline thresholds for recommended statin initiation. Total study duration will be approximately 96 months from the time the first participant is enrolled.
Participants will be randomly assigned to receive 4 mg of pitavastatin or placebo once a day for the entire time they are enrolled in the study. Study visits will occur at study entry (Day 0) and Months 1 and 4. Starting at Month 4, study visits will occur every 4 months for the rest of the study. Depending on when participants enroll, they will be in the study for a total of 3 to 8 years. Study visits will include 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).
Some participants will have the option of enrolling in a substudy (Effects of Pitavastatin on Coronary Artery Disease and Inflammatory Biomarkers: Mechanistic Substudy of REPRIEVE [A5333s]). The substudy will evaluate the effect of pitavastatin on the progression of non-calcified coronary atherosclerotic plaque (NCP) and inflammatory biomarkers in adults infected with HIV. Participants in the substudy will attend study visits at study entry and Months 4 and 24. The visits will include questionnaires and assessments, a blood collection, and a coronary computed tomography angiography (CCTA). NOTE: The Mechanistic Substudy of REPRIEVE (A5333s) closed to accrual on 02/06/18.
Participants enrolled in REPRIEVE from select study sites, including international sites, through December, 2017, are included in the REPRIEVE Kidney Function Objectives Cohort to evaluate the effects of pitavastatin on parameters of kidney function in the setting of HIV infection. The analyses will also include an assessment of high risk groups and mechanisms driving kidney function decline in the setting of HIV infection.
Women and men enrolled in REPRIEVE after February, 2016 are included in an observational cohort (REPRIEVE Women's Objectives Cohort) facilitating assessment of sex-specific mechanisms of CVD risk and risk reduction among adults with HIV. This effort also includes an evidence-based recruitment campaign to enhance women's participation in REPRIEVE.

Eligibility

Eligibility

Ages Eligible for Study: 40 Years to 75 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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 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 be 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 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: Exceptions:
      • Successfully treated non-melanomatous skin cancer
      • 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. NOTE: Use of oral prednisone less than or equal to 10 mg/day or equivalent dosage 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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02344290

Locations

United States, Alabama
Alabama CRS
Birmingham, Alabama, United States, 35294
United States, Arizona
University of Arizona CRS
Tucson, Arizona, United States, 85724
United States, California
University of Southern California CRS
Los Angeles, California, United States, 90033-1079
UCLA CARE Center CRS
Los Angeles, California, United States, 90035
Mills Clinical Research CRS
Los Angeles, California, United States, 90069
VA West Los Angeles Medical Center CRS
Los Angeles, California, United States, 90073
Los Angeles LGBT Center CRS
Los Angeles, California, United States, 90232
Eisenhower Health Center at Rimrock CRS
Palm Springs, California, United States, 92264
Stanford AIDS Clinical Trials Unit CRS
Palo Alto, California, United States, 94304-5350
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
Ucsf Hiv/Aids Crs
San Francisco, California, United States, 94110
Harbor-UCLA CRS
Torrance, California, United States, 90502
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
Denver Public Health CRS
Denver, Colorado, United States, 80204
United States, Connecticut
Yale University CRS
New Haven, Connecticut, United States, 06510
VA Connecticut Healthcare System CRS
West Haven, Connecticut, United States, 06516
United States, District of Columbia
Whitman-Walker Health CRS
Washington, District of Columbia, United States, 20005
Georgetown University CRS (GU CRS)
Washington, District of Columbia, United States, 20007
Capital Medical Associates, PC CRS
Washington, District of Columbia, United States, 20036
Infectious Diseases Clinic, Washington DC Veterans Affairs Medical Center CRS
Washington, District of Columbia, United States, 20422
United States, Florida
Malcom Randall VA Medical Center CRS
Gainesville, Florida, United States, 32610
AHF-The Kinder Medical Group CRS
Miami, Florida, United States, 33133
The University of Miami AIDS Clinical Research Unit (ACRU) CRS
Miami, Florida, United States, 33136
University of Miami Infectious Disease Research Unit at Jackson Memorial Hospital CRS
Miami, Florida, United States, 33136
AHF - South Beach CRS
Miami, Florida, United States, 33140
Orlando Immunology Center CRS
Orlando, Florida, United States, 32803
Community AIDS Network/Comprehensive Care Clinic CRS
Sarasota, Florida, United States, 34237
Florida Department of Health - Hillsborough County
Tampa, Florida, United States, 33602
AIDS Research and Treatment Center of the Treasure Coast CRS
Vero Beach, Florida, United States, 32960
United States, Georgia
The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308-2012
Augusta University Research Institute, Inc. CRS
Augusta, Georgia, United States, 30912
United States, Illinois
Northwestern University CRS
Chicago, Illinois, United States, 60611
Rush University CRS
Chicago, Illinois, United States, 60612
UIC Project WISH CRS
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Infectious Diseases Research CRS
Indianapolis, Indiana, United States, 46202
United States, Iowa
Department of Internal Medicine, University of Iowa Hospitals & Clinics CRS
Iowa City, Iowa, United States, 52242
United States, Kentucky
Bluegrass Care Clinic/University of Kentucky Research Foundation CRS
Lexington, Kentucky, United States, 40536
550 Clinic -University of Louisville CRS
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane - Louisiana Community AIDS Research Program (T-LaCARP) CRS
New Orleans, Louisiana, United States, 70112
United States, Maryland
Johns Hopkins University CRS
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Tufts Medical Center CRS
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, United States, 02115
Boston Medical Center CRS
Boston, Massachusetts, United States, 02118
Baystate Infectious Diseases Clinical Research CRS
Springfield, Massachusetts, United States, 01199
United States, Michigan
Henry Ford Hosp. CRS
Detroit, Michigan, United States, 48202
St. John Newland Medical Associates CRS
Southfield, Michigan, United States, 48075
United States, Minnesota
Abbott Northwestern Hospital CRS
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
University of Mississippi Medical Center CRS
Jackson, Mississippi, United States, 39213
United States, Missouri
Washington University Therapeutics (WT) CRS
Saint Louis, Missouri, United States, 63110-1010
United States, Nebraska
Specialty Care Center CRS
Omaha, Nebraska, United States, 68106
United States, New Jersey
Cooper Univ. Hosp. CRS
Camden, New Jersey, United States, 08103
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States, 07103
United States, New York
James J Peters VA Medical Center CRS
Bronx, New York, United States, 10468
Mount Sinai Beth Israel CRS
New York, New York, United States, 10003
VA New York Harbor Healthcare System (NYHHS), NY Campus CRS
New York, New York, United States, 10010
Weill Cornell Chelsea CRS
New York, New York, United States, 10010
Mount Sinai Downtown CRS
New York, New York, United States, 10011
Mount Sinai West Samuels CRS
New York, New York, United States, 10019
Mount Sinai St. Luke's Morningside CRS
New York, New York, United States, 10025
Infectious Disease Clinical and Translational Research Center (CTRC) CRS
New York, New York, United States, 10029
Columbia P&S CRS
New York, New York, United States, 10032-3732
Weill Cornell Uptown CRS
New York, New York, United States, 10065
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, United States, 14642
United States, North Carolina
Chapel Hill CRS
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center CRS
Durham, North Carolina, United States, 27710
Greensboro CRS
Greensboro, North Carolina, United States, 27401
Wake Forest Baptist Medical Center CRS
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cincinnati Clinical Research Site
Cincinnati, Ohio, United States, 45219
Case Clinical Research Site
Cleveland, Ohio, United States, 44106
Ohio State University CRS
Columbus, Ohio, United States, 43210
University of Toledo Medical Center CRS
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma State University Center for Health Sciences CRS
Tulsa, Oklahoma, United States, 74127
United States, Pennsylvania
Division of Infectious Diseases Clinical Research Center- Drexel University CRS
Philadelphia, Pennsylvania, United States, 19102
Penn Therapeutics, CRS
Philadelphia, Pennsylvania, United States, 19104
Center of Translational AIDS Research, Lewis Katz School of Medicine at Temple University CRS
Philadelphia, Pennsylvania, United States, 19140
Positive Health Clinic CRS
Pittsburgh, Pennsylvania, United States, 15212
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
The Miriam Hospital Clinical Research Site (TMH CRS) CRS
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina: Division of Infectious Diseases CRS
Charleston, South Carolina, United States, 29425
Palmetto Health Clinical Trial Department CRS
Columbia, South Carolina, United States, 29209
United States, Tennessee
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States, 37204
United States, Texas
Trinity Health and Wellness Center CRS
Dallas, Texas, United States, 75208
Dallas VA Medical Center CRS
Dallas, Texas, United States, 75216
UT Southwestern HIV/ID Clinical Trials Unit CRS
Dallas, Texas, United States, 75235-9173
Houston AIDS Research Team CRS
Houston, Texas, United States, 77030
Michael E. DeBakey VAMC REPRIEVE CRS
Houston, Texas, United States, 77030
United States, Virginia
Inova Heart and Vascular Institute CRS
Falls Church, Virginia, United States, 22042
Virginia Commonwealth University CRS
Richmond, Virginia, United States, 23298
United States, Washington
University of Washington AIDS CRS
Seattle, Washington, United States, 98104-9929
United States, Wisconsin
Medical College of Wisconsin, Inc. CRS
Milwaukee, Wisconsin, United States, 53226
Botswana
Gaborone CRS
Gaborone, South-East District, Botswana
Brazil
Tropical Medicine Foundation Dr. Heitor Vieira Dourado CRS
Manaus, Amazonas, Brazil, 69040000
School of Medicine, Federal University of Minas Gerais CRS
Belo Horizonte, Minas Gerais, Brazil, 30130-100
HGNI HIV Family Care Clinic - HHFCC CRS
Nova Iguacu, Rio De Janeiro, Brazil, 26030-380
Hospital Nossa Senhora da Conceicao CRS
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Centro de Referencia e Treinamento DST/AIDS CRS
Sao Paulo, São Paulo, Brazil, 04121-000
Projeto Praça Onze Pesquisa em Saúde CRS
Rio de Janeiro, Brazil, 20020-000
Hospital Federal dos Servidores do Estado CRS
Rio de Janeiro, Brazil, 20221-903
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, Brazil, 21040-360
Instituto de Infectologia Emilio Ribas CRS
Sao Paulo, Brazil, 01246-900
Centro de Pesquisas Clínicas IC-HCFMUSP CRS
Sao Paulo, Brazil, 05403-010
Canada
Vancouver ID Research & Care Centre Society CRS
Vancouver, British Columbia, Canada, V6Z 2C7
Hamilton Health Sciences - Special Immunology Services Clinic CRS
Hamilton, Ontario, Canada, L8S 1A4
Maple Leaf Research CRS
Toronto, Ontario, Canada, M5G 1K2
Toronto General Hospital CRS
Toronto, Ontario, Canada, M5G 2N2
Chronic Viral Illness Service CRS
Montreal, Quebec, Canada, H4A 3J1
Centre hospitalier de l'Université Laval CRS
Quebec City, Quebec, Canada, G1V 4G2
Haiti
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
Port-au-Prince, Haiti, HT-6110
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
Port-au-Prince, Haiti, HT-6110
India
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, India, 411001
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, India, 600113
Peru
Barranco CRS
Lima, Peru, 15063
San Miguel CRS
Lima, Peru, 32 - 15088
Puerto Rico
Puerto Rico AIDS Clinical Trials Unit CRS
San Juan, Puerto Rico, 00935
South Africa
Soweto ACTG CRS
Johannesburg, Gauteng, South Africa, 1862
Wits Helen Joseph Hospital CRS (Wits HJH CRS)
Johannesburg, Gauteng, South Africa, 2092
Durban International Clinical Research Site CRS
Durban, Kwa Zulu Natal, South Africa, 4052
University of Cape Town Lung Institute (UCTLI) CRS
Cape Town, Western Cape Province, South Africa, 7700
Famcru Crs
Tygerberg, Western Cape Province, South Africa, 7505
Spain
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Germans Trias i Pujol
Badalona, Spain, 080916
Hospital Universitario Valle d'Hebron
Barcelona, Spain, 08003
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de Bellvitge
Barcelona, Spain, 08907
Hospital Universitario de Basurto de Basurto
Bilbao, Spain, 48013
Hospital General Universitario De Elche
Elche, Spain, 03203
Hospital Gregorio Universitario Maranon
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Thailand
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Bangkok, Thailand, 10330
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, Thailand, 50200
Uganda
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
Kampala, Uganda
Zimbabwe
Milton Park CRS
Harare, Zimbabwe

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
National Heart, Lung, and Blood Institute (NHLBI)
Kowa Pharmaceuticals America, Inc.
Gilead Sciences
Massachusetts General Hospital (MGH)
NEAT ID

Investigators

Study Chair: Steven Grinspoon, MD Harvard Medical School
More Information

More Information

Additional Information:

REPRIEVE Trial Website

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT02344290   History of Changes  
Other Study ID Numbers: A5332  
  11960  
  1U01HL123339-01  
  1U01HL123336-01  
  EU5332  
Study First Received: January 16, 2015  
Last Updated: February 4, 2020  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

HIV
Cardiovascular Disease
Myocardial Infarction
Inflammation
Statin
Computerized Tomography
Cholesterol

Additional relevant MeSH terms:
Cardiovascular Diseases
Pitavastatin

ClinicalTrials.gov processed this data on March 27, 2020
This information is provided by ClinicalTrials.gov.