Subjects With Hyperlipidemia, Dyslipidemia and HIV InfectionPhase 3NCT02833844

Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia

A Phase 3 study testing Evolocumab in people with Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection, run by Amgen at 78 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
What is being tested?: Evolocumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 467 participants
Where: 78 sitesin 15 countries
Study dates: 22 May 2017to 27 Jan 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

78 sites in 15 countries.

Country

City, postcode or hospital

78 sites in 15 countries

United States20 sites

Research Site
Albany, New York, 12208
Research Site
Augusta, Georgia, 30912
Research Site
Berkley, Michigan, 48072
Research Site
Camden, New Jersey, 08103
Research Site
Cincinnati, Ohio, 45267
Research Site
Detroit, Michigan, 48202
Research Site
Falls Church, Virginia, 22042
Research Site
Hartford, Connecticut, 06102
Research Site
Los Angeles, California, 90035
Research Site
Miami, Florida, 33136
Research Site
Minneapolis, Minnesota, 55415
Research Site
New York, New York, 10029
Research Site
Southfield, Michigan, 48075
Research Site
St Louis, Missouri, 63110
Research Site
Tampa, Florida, 33602
Research Site
The Bronx, New York, 10467
Research Site
Vero Beach, Florida, 32960
Research Site
Washington D.C., District of Columbia, 20005
Research Site
Washington D.C., District of Columbia, 20007
Research Site
Washington D.C., District of Columbia, 20037

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France7 sites

Research Site
Bordeaux, 33075
Research Site
Lyon, 69317
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Paris, 75475
Research Site
Paris, 75571
Research Site
Paris, 75651

Other trials in France

Australia6 sites

Research Site
Darlinghurst, New South Wales, 2010
Research Site
East Sydney, New South Wales, 2010
Research Site
Fortitude Valley, Queensland, 4006
Research Site
Melbourne, Victoria, 3004
Research Site
Prahran, Victoria, 3181
Research Site
Sydney, New South Wales, 2010

Other trials in Australia

Italy6 sites

Research Site
Bologna, 40138
Research Site
Genova, 16132
Research Site
Milan, 20157
Research Site
Modena, 41100
Research Site
Pisa, 56124
Research Site
Roma, 00149

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Canada5 sites

Research Site
Calgary, Alberta, T2R 0X7
Research Site
Hamilton, Ontario, L8S 1A4
Research Site
Montreal, Quebec, H4A 3T2
Research Site
Québec, Quebec, G1V 4G2
Research Site
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Greece5 sites

Research Site
Athens, 10676
Research Site
Athens, 11527
Research Site
Athens, 12462
Research Site
Athens, 16121
Research Site
Thessaloniki, 54636

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Portugal4 sites

Research Site
Almada, 2801-951
Research Site
Aveiro, 3814-501
Research Site
Coimbra, 3000-075
Research Site
Porto, 4200-319

Other trials in Portugal

Romania4 sites

Research Site
Brasov, 500174
Research Site
Bucharest, 021105
Research Site
Constanța, 900708
Research Site
Timișoara, 300310

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Spain4 sites

Research Site
Barcelona, Catalonia, 08035
Research Site
Barcelona, Catalonia, 08036
Research Site
Madrid, 28040
Research Site
Madrid, 28046

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Switzerland4 sites

Research Site
Geneva, 1211
Research Site
Lausanne, 1011
Research Site
Lugano, 6900
Research Site
Zurich, 8091

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Belgium3 sites

Research Site
Antwerp, 2000
Research Site
Brussels, 1000
Research Site
Ghent, 9000

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Brazil3 sites

Research Site
Rio de Janeiro, 21040-900
Research Site
São Paulo, São Paulo, 04121-000
Research Site
São Paulo, 05403-000

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South Africa3 sites

Research Site
Bloemfontein, 9301
Research Site
Pretoria, Gauteng, 0122
Research Site
Westdene, Gauteng, 2092

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United Kingdom3 sites

Research Site
London, SE1 9RT
Research Site
London, SW10 9NH
Research Site
London, W2 1NY

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Poland1 site

Research Site
Warsaw, 01-201

Other trials in Poland

About this study

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

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.

Conditions: Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection
Being tested: Evolocumab, Placebo
Keywords: Hyperlipidemia, Dyslipidemia, Proprotein convertase subtilisin/kexin type 9 (PCSK9), Inhibition, HIV infection, Cluster of differentiation, Viral load
Medical subject headings: Dyslipidemias, HIV Infections, Hyperlipidemias, Hypercholesterolemia, Autosomal Dominant, 3, Inhibition, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EvolocumabDrug
Also called EvoMab, Repatha, AMG 145
Dose of subcutaneous evolocumab QM
PlaceboDrug
Dose of matching placebo QM

Study groups in NCT02833844
Study group	Role	What they receive
Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM	Experimental	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. Receives: Drug: Evolocumab; Drug: Placebo
Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM	Placebo comparator	Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks. Receives: Drug: Evolocumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.)
Measured: Baseline, Week 24

Secondary outcomes (10)

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.)
Measured: Baseline, Week 24
Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24
Measured: Week 24
Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24
Measured: Baseline, 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.)
Measured: Baseline, Week 24
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.)
Measured: Baseline, Week 24
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.)
Measured: Baseline, Week 24
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.)
Measured: Baseline, Week 24
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.)
Measured: Baseline, Week 24
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.)
Measured: Bseline, Week 24
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.)
Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201727 Jan 2020

First posted14 Jul 2016 (estimated)
Study start22 May 2017
Primary completion9 Jul 2019
Study completion27 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Subjects With Hyperlipidemia, Dyslipidemia and HIV InfectionStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 467 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02833844
Sponsor's protocol ID: 20130286
Other IDs: 2015-004735-12, 2015
Status last verified: Jul 2022
First submitted: 13 Jun 2016
Last updated: 22 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

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.
PubMed 32234462
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.
PubMed 31841795
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.
PubMed 35025817
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.
PubMed 33078867

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02833844
Acronym / sponsor ID: 20130286
Conditions: 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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 467 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 22 May 2017 (actual)
Primary completion: 9 Jul 2019 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 14 Jul 2016 (estimated)
Results: Posted 21 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM	Experimental	Drug: Evolocumab, Drug: PlaceboDouble-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 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM	Placebo comparator	Drug: EvolocumabDouble-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EvolocumabAlso: EvoMab, Repatha, AMG 145Dose of subcutaneous evolocumab QM	Drug	Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM, Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM
PlaceboDose of matching placebo QM	Drug	Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM

Primary outcome

Percent Change From Baseline in LDL-C at Week 24
Time frame: Baseline, 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.)

10 secondary outcomes

Change From Baseline in LDL-C at Week 24
Time frame: Baseline, Week 24
Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24
Time frame: Week 24
Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-C) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Apolipoprotein B (ApoB) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Total Cholesterol (TC) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in Triglycerides at Week 24
Time frame: Baseline, Week 24
Percent Change From Baseline in HDL-C at Week 24
Time frame: Bseline, Week 24
Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-C) at Week 24
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 21 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double-Blind Placebo/Open-Label Evolocumab	157	155
Double-Blind Evolocumab/Open-Label Evolocumab	310	303

Primary outcome: Percent Change From Baseline in LDL-C at Week 24

Time frame: Baseline, Week 24. Least squares mean (Standard Error). Unit: percent change

Measure	Double-Blind Placebo n = 151	Double-Blind Evolocumab n = 295
Value	1.68 (2.03)	-55.23 (1.52)

Double-Blind Placebo vs Double-Blind Evolocumab: treatment difference: -56.92 (95% CI -61.55 to -52.28), p < 0.0001, repeated measures linear effects model

Population analysed: Full Analysis Set: randomized participants who received at least 1 dose of investigational product. Participants with an assessment.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Double-blind Treatment (DBT) Period: From randomization (for all-cause mortality) or first dose of study drug (for adverse events) to up to week 24. Open-label Extension (OLE) Period: From the start of the OLE (week 24) to end of study (week 52) for all-cause mortality; and from first dose of study drug in the OLE up to 30 days after last dose, or end of study, whichever was earlier, for adverse events.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-Blind Placebo	8 of 157 (5.1%)	41 of 157 (26.1%)	0 of 157
Double-Blind Evolocumab	10 of 307 (3.3%)	78 of 307 (25.4%)	0 of 310
Double-Blind Placebo/Open-Label Evolocumab	8 of 152 (5.3%)	23 of 152 (15.1%)	0 of 152
Double-Blind Evolocumab/Open-Label Evolocumab	14 of 299 (4.7%)	50 of 299 (16.7%)	2 of 303

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 32234462Boccara 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.
Background: PubMed 31841795Boccara 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.
Background: PubMed 35025817Boccara 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.
Derived from this study: PubMed 33078867Schmidt 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

78 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Evolocumab in people with Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection, run by Amgen at 78 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, France, Australia, Italy, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in LDL-C at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02833844, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.