Back to resultsSafety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
Primary Purpose
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Evolocumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection focused on measuring Hyperlipidemia, Dyslipidemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Inhibition, HIV infection, Cluster of differentiation, Viral load
Eligibility Criteria
Inclusion Criteria:
- Male or female ≥ 18 years of age
- 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:
- Taking a combination of background lipid-lowering therapy and HIV therapy known to have significant drug-drug interaction
- 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
Other exclusion criteria may apply.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM
Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM
Arm Description
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.
Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.
Outcomes
Primary Outcome Measures
Percent Change From Baseline in LDL-C at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Secondary Outcome Measures
Change From Baseline in LDL-C at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24
Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in Total Cholesterol (TC) at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in Triglycerides at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in HDL-C at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 24
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02833844
Brief Title
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
Official Title
A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2017 (Actual)
Primary Completion Date
July 9, 2019 (Actual)
Study Completion Date
January 27, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Keywords
Hyperlipidemia, Dyslipidemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Inhibition, HIV infection, Cluster of differentiation, Viral load
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
467 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM
Arm Type
Experimental
Arm Description
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.
Arm Title
Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM
Arm Type
Placebo Comparator
Arm Description
Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Evolocumab
Other Intervention Name(s)
EvoMab, Repatha, AMG 145
Intervention Description
Dose of subcutaneous evolocumab QM
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose of matching placebo QM
Primary Outcome Measure Information:
Title
Percent Change From Baseline in LDL-C at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in LDL-C at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24
Time Frame
Week 24
Title
Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Total Cholesterol (TC) at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in Triglycerides at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
Title
Percent Change From Baseline in HDL-C at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Bseline, Week 24
Title
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 24
Description
Least squares mean is from the repeated measures model which includes treatment group, statin stratification factor, scheduled visit and the interaction of treatment with scheduled visit as covariates. (Hepatitis C stratification factor is not included in the model due to low participant numbers.)
Time Frame
Baseline, Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ≥ 18 years of age
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:
Taking a combination of background lipid-lowering therapy and HIV therapy known to have significant drug-drug interaction
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
Other exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Research Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33602
Country
United States
Facility Name
Research Site
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Research Site
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Research Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Research Site
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Research Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Research Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Research Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
East Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Research Site
City
Fortitude Valley
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Research Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Research Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Research Site
City
Antwerp
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04121-000
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
21040-900
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Research Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 1A4
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3T2
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Research Site
City
Lyon cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Research Site
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Research Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Research Site
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Research Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Research Site
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
16121
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Research Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Research Site
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Research Site
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Research Site
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
Research Site
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Research Site
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500174
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
021105
Country
Romania
Facility Name
Research Site
City
Constanta
ZIP/Postal Code
900708
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
Research Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0122
Country
South Africa
Facility Name
Research Site
City
Westdene
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Geneva 14
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Research Site
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Research Site
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Research Site
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
IPD Sharing URL
https://www.amgen.com/datasharing
Citations:
PubMed Identifier
32234462
Citation
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. Erratum In: J Am Coll Cardiol. 2020 Aug 11;76(6):762-765.
Results Reference
background
PubMed Identifier
31841795
Citation
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.
Results Reference
background
PubMed Identifier
35025817
Citation
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.
Results Reference
background
PubMed Identifier
33078867
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia
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