Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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CTRI |
Last refreshed on:
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19 December 2023 |
Main ID: |
CTRI/2017/08/009558 |
Date of registration:
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31-08-2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Randomized Trial to Prevent Vascular Events in HIV - REPRIEVE
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Scientific title:
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REPRIEVE (A5332) Randomised Trial to Prevent Vascular Events in HIV - A5332 |
Date of first enrolment:
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07-08-2017 |
Target sample size:
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6500 |
Recruitment status: |
Completed |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18561 |
Study type:
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Interventional |
Study design:
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Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
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Phase:
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Phase 3
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Countries of recruitment
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Botswana
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Brazil
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Canada
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South Africa
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Thailand
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United States of America
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Contacts
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Name:
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Dr Vidya Mave
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Address:
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BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals
411001
Pune, MAHARASHTRA
India |
Telephone:
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Email:
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vidyamave@gmail.com |
Affiliation:
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B J Govt Medical College |
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Name:
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Dr Nishi Suryavanshi
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Address:
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BJMC CTU, 1st floor Pathology Museum, BJ Govt medical college and Sassoon General Hospitals
411001
Pune, MAHARASHTRA
India |
Telephone:
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Email:
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vidyamave@gmail.com |
Affiliation:
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B J Govt Medical College |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1 HIV 1 infected individuals
2 Combination antiretroviral therapy ART for at least 180 days prior to study entry
3 CD4 plus cell count greater than 100 cells per mm cube
4 Acceptable screening laboratories including a
Fasting low-density lipoprotein LDL cholesterol as follows If ASCVD risk score is less than 7.5 percent LDL cholesterol must be less than 190 mg per dL
If ASCVD risk score is greater than or equal to 7.5 percent and less than or equal to 10 percent LDL must be less than 160 mg per dL
If ASCVD risk score is greater than 10 percent and less than or equal to 15percent LDL must be less than 130 mg per dL
NOTE If LDL is less than 70 mg per dL participant is eligible regardless of risk score in line with the ACC AHA 2013 Prevention Guidelines
Fasting triglycerides less than 500 mg per dL
Hemoglobin greater than or equal to 8 g per dL for female participants and greater than or equal to 9 g per dL for male participants
Glomerular filtration rate GFR greater than or equal to 60 mL per min per 1.73m square or creatinine clearance CrCl greater than or equal to 60 mL per min
Alanine aminotransferase ALT less than or equal to 2.5 times the upper limit of normal
5 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
6 Men and women 40 to 75 years of age
7 Ability and willingness of participant or legal representative to provide written informed consent
Exclusion criteria: 1 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
2 Current diabetes mellitus if LDL is greater than or equal to 70 mg/dL
3 10-year ASCVD risk score estimated by Pooled Cohort Equations greater than 15%
4 Active cancer within 36 months prior to study entry (Subjects with successfully treated non-melanomatous skin cancer within 36 months prior to study entry are acceptable.)
5 Known cirrhosis
History of myositis or myopathy with active disease in the 180 days prior to study entry
6 Known untreated symptomatic thyroid disease
7 History of allergy or severe adverse reaction to statins
8 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.
9 Current use of erythromycin, colchicine, or rifampin
10 Use of any statin drugs, gemfibrozil, or PCSK9 inhibitors in the 90 days prior to study entry
11 Current use of an investigational new drug that would be contraindicated
12 Serious illness or trauma requiring systemic treatment or hospitalization in the 30 days prior to study entry
13 Current pregnancy or breastfeeding
14 Alcohol or drug use that, in the opinion of the site investigator, would interfere with completion of study procedures
15 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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- HIV infected patients with cardiovascular disease
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Intervention(s)
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Intervention1: Pitavastatin One tablet 4 mg taken once daily orally with or without food: Participants will receive pitavastatin once a day for the entire time they are enrolled in the study. Control Intervention1: Placebo One tablet taken once daily orally with or without food: Placebo Participants will receive placebo for pitavastatin once a day for the entire time they are enrolled in the study
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Primary Outcome(s)
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Time to the first event of a composite of major cardiovascular events
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.)Timepoint: Measured through participants final study visit, at approximately Month 42 to 72
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Secondary Outcome(s)
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Time to the first of each individual component of the primary endpoint
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
Time to death (all-cause mortality) and/or major adverse cardiovascular events (MACE)
Timepoint: Measured through participants final study visit at approximately Month 42 to 72
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Secondary ID(s)
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NCT02344290
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A5332 version 3.0 28 Jan 2016
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Source(s) of Monetary Support
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National Institute of Allergy and Infectious Diseases, Division of AIDS, Maryland, USA
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Ethics review
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Status: Approved
Approval date: 29/11/2016
Contact:
Ethics Commitee B.J.Medical College and Sassoon General Hospital
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/07/2023 |
URL:
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