Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
NCT ID: NCT02833844
Last Updated: 2022-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
467 participants
INTERVENTIONAL
2017-05-22
2020-01-27
Brief Summary
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The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM
Double-blind placebo subcutaneous (SC) injection every 4 weeks (QM) for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.
Evolocumab
Dose of subcutaneous evolocumab QM
Placebo
Dose of matching placebo QM
Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM
Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.
Evolocumab
Dose of subcutaneous evolocumab QM
Interventions
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Evolocumab
Dose of subcutaneous evolocumab QM
Placebo
Dose of matching placebo QM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known HIV infection with stable HIV therapy for ≥ 6 months
* Cluster of differentiation 4 (CD4) ≥ 250 cells/mm\^3 for ≥ 6 months
* HIV viral load ≤ 50 copies/mL at screening and ≤ 200 copies/mL for ≥ 6 months
* Subject on stable lipid-lowering therapy for ≥ 4 weeks prior to randomization and not expected to change during the duration of study
* For subjects with known clinical atherosclerotic cardiovascular disease (ASCVD), fasting LDL-C of ≥ 70 mg/dL or non-high density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL. For subjects without known clinical ASCVD: fasting LDL-C of ≥ 100 mg/dL or non-HDL-C of ≥ 130 mg/dL
* Fasting triglycerides ≤ 600 mg/dL (6.8 mmol/L)
Exclusion Criteria
* New York Heart Association (NYHA) III or IV heart failure, or last known left ventricular ejection fraction (LVEF) \< 30%
* Known opportunistic infection/acquired immunodeficiency syndrome (AIDS) defining illness within 1 year prior to randomization
* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months
* Type 1 diabetes, new-onset or poorly controlled type 2 diabetes
* Uncontrolled hypertension
* Taken a cholesteryl ester transfer protein inhibitor in the last 12 months
* Moderate to severe renal dysfunction
* Persistent active liver disease or hepatic dysfunction (Stable chronic hepatitis C of at least 1 year duration prior to randomization is allowed)
* Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or stage 1 prostate carcinoma) within the last 5 years prior to randomization
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Los Angeles, California, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Augusta, Georgia, United States
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Berkley, Michigan, United States
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Detroit, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Camden, New Jersey, United States
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Albany, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Cincinnati, Ohio, United States
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Falls Church, Virginia, United States
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Darlinghurst, New South Wales, Australia
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East Sydney, New South Wales, Australia
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Sydney, New South Wales, Australia
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Fortitude Valley, Queensland, Australia
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Melbourne, Victoria, Australia
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Prahran, Victoria, Australia
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Antwerp, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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São Paulo, , Brazil
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Hamilton, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Bordeaux, , France
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Lyon, , France
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Montpellier, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Bologna, , Italy
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Genova, , Italy
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Milan, , Italy
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Modena, , Italy
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Pisa, , Italy
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Roma, , Italy
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Warsaw, , Poland
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Almada, , Portugal
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Aveiro, , Portugal
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Coimbra, , Portugal
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Porto, , Portugal
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Brasov, , Romania
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Bucharest, , Romania
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Constanța, , Romania
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Timișoara, , Romania
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Pretoria, Gauteng, South Africa
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Westdene, Gauteng, South Africa
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Bloemfontein, , South Africa
Research Site
Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Geneva, , Switzerland
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Lausanne, , Switzerland
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Lugano, , Switzerland
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Zurich, , Switzerland
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London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Countries
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References
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Boccara F, Kumar PN, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS; BEIJERINCK Investigators. Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study. J Am Coll Cardiol. 2020 May 26;75(20):2570-2584. doi: 10.1016/j.jacc.2020.03.025. Epub 2020 Mar 28.
Boccara F, Kumar P, Caramelli B, Calmy A, Lopez JAG, Bray S, Cyrille M, Rosenson RS. Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics. Am Heart J. 2020 Feb;220:203-212. doi: 10.1016/j.ahj.2019.11.004. Epub 2019 Nov 12.
Boccara F, Caramelli B, Calmy A, Kumar P, Lopez JAG, Bray S, Cyrille M, Rosenson RS; investigators of the BEIJERINCK study. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period. AIDS. 2022 Apr 1;36(5):675-682. doi: 10.1097/QAD.0000000000003175.
Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2015-004735-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130286
Identifier Type: -
Identifier Source: org_study_id
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