Clinical Trials

MainTitle

Safety, Tolerability & Efficacy on LDL-C of Evolocumab in Subjects With HIV & Hyperlipidemia/Mixed Dyslipidemia

This study is currently recruiting participants. (see Contacts and Locations)

Verified November 2017 by Amgen

Sponsor
Amgen


Information provided by (Responsible Party)
Amgen
ClinicalTrials.gov Identifier
NCT02833844

First received: June 13, 2016
Last updated: November 9, 2017
Last Verified: November 2017
History of Changes
Purpose

Purpose

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, subjects will be randomized in a ratio of 2:1 to receive either Repatha (evolocumab) QM or placebo QM.

The second part of the study is a 24-week open label extension period. During this time all subjects will receive Repatha (evolocumab) QM.

The clinical hypothesis is that subcutaneous Repatha (evolocumab) QM will be well tolerated and will result in greater reduction of LDL-C, defined as percent change from baseline at week 24, compared with placebo QM in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia.

Condition Intervention Phase
Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection

Drug : Repatha (Evolocumab)
Drug : Placebo
Drug : Repatha (Evolocumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Amgen:

Primary Outcome Measures

  • Effect of Repatha (Evolocumab) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in human immunodeficiency virus (HIV)-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    HIV = human immunodeficiency virus
Secondary Outcome Measures:
  • Effect of Repatha (Evolocumab) on change from baseline in LDL-C in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    LDL-C=low-density lipoprotein cholesterol
  • Effect of Repatha (Evolocumab) on percent of subjects attaining LDL-C < 70 mg/dL (1.8 mmol/L) in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    LDL-C=low-density lipoprotein cholesterol
  • Effect of Repatha (Evolocumab) on percent of subjects attaining a 50% reduction in LDL-C from baseline in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    LDL-C=low-density lipoprotein cholesterol
  • Effect of Repatha (Evolocumab) on percent change from baseline in ApoB in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    ApoB=apolipoprotein B
  • Effect of Repatha (Evolocumab) on percent change from baseline in TC in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    TC=total cholesterol
  • Effect of Repatha (Evolocumab) on percent chang from baseline in Lp(a) in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    Lp(a)=lipoprotein(a)
  • Effect of Repatha (Evolocumab) on percent change from baseline in triglycerides in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
  • Effect of Repatha (Evolocumab) on percent change from baseline in HDL-C in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    HDL-C=high-density lipoprotein cholesterol
  • Effect of Repatha (Evolocumab) on percent change from baseline in non-HDL-C in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    non-HDL-C=non-high-density lipoprotein cholesterol
  • Effect of Repatha (Evolocumab) on percent change from baseline in VLDL-C in HIV-positive subjects with hyperlipidemia or mixed dyslipidemia [ Time Frame: Week 24 ]
    VLDL-C=very low-density lipoprotein cholesterol
Other Outcome Measures:
  • Subject incidence of treatment emergent adverse events [ Time Frame: From date of screening until week 52 Visit (defined as end of study). ]
  • Safety laboratory values and vital signs at each scheduled assessment [ Time Frame: From date of screening until week 52 Visit (defined as end of study). ]
  • Incidence of anti-evolocumab antibody (binding and neutralizing) formation at each scheduled assessment [ Time Frame: From date of randomisation until week 52 Visit (defined as end of study). ]

Estimated Enrollment: 450
Study Start Date: May 22, 2017
Estimated Study Completion Date: February 7, 2020
Estimated Primary Completion Date: July 26, 2019 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 24-week Double Blind Period Repatha (Evolocumab)
Repatha (Evolocumab) subcutaneous injection every 4 weeks (QM)
Drug: Repatha (Evolocumab)

Dose of subcutaneous Repatha (Evolocumab) every 4 weeks (QM)

Placebo Comparator: 24-week Double Blind Period Repatha (Evolocumab) Placebo
Repatha (Evolocumab) Matching Placebo subcutaneous injection every 4 weeks (QM)
Drug: Placebo

Dose of subcutaneous Repatha (Evolocumab) Matching Placebo every 4 weeks (QM)

Experimental: 24-week Open Label Period Repatha (Evolocumab)
Repatha (Evolocumab) subcutaneous injection every 4 weeks (QM)
Drug: Repatha (Evolocumab)

Dose of subcutaneous Repatha (Evolocumab) every 4 weeks (QM)

Detailed Description:

LDL-C = low density lipoprotein cholesterol QM = once monthly Double blind = neither the subject, the site staff nor the Sponsor study team will know whether the subject is receiving either evolocumab or placebo Open label = all subjects receive evolocumab

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Known HIV (human immunodeficiency virus) infection with stable HIV therapy for ≥ 6 months
  • Cluster of differentiation 4 (CD4) ≥ 250 cells/mm3 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 astherosclerotic CVD (ASCVD), fasting LDL-C of ≥ 70 mg/dL or 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
  • NYHA III or IV heart failure, or last known left ventricular ejection fraction (LVEF) < 30%
  • Known opportunistic infection/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 cholesterylester 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.

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: NCT02833844

Contacts

Contact:   Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations

United States, California
Research Site Recruiting
Los Angeles, California, United States, 90035
United States, Connecticut
Research Site Recruiting
Hartford, Connecticut, United States, 06102
United States, District of Columbia
Research Site Recruiting
Washington, District of Columbia, United States, 20005
Research Site Recruiting
Washington, District of Columbia, United States, 20007
Research Site Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Research Site Recruiting
Miami, Florida, United States, 33136
Research Site Recruiting
Tampa, Florida, United States, 33602
Research Site Recruiting
Vero Beach, Florida, United States, 32960
United States, Georgia
Research Site Recruiting
Augusta, Georgia, United States, 30912
United States, Michigan
Research Site Recruiting
Berkley, Michigan, United States, 48072
Research Site Recruiting
Detroit, Michigan, United States, 48202
Research Site Recruiting
Southfield, Michigan, United States, 48075
United States, Minnesota
Research Site Recruiting
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Research Site Recruiting
Camden, New Jersey, United States, 08103
United States, New York
Research Site Recruiting
Albany, New York, United States, 12208
Research Site Recruiting
New York, New York, United States, 10029
Research Site Recruiting
The Bronx, New York, United States, 10467
United States, Ohio
Research Site Recruiting
Cincinnati, Ohio, United States, 45267
United States, Virginia
Research Site Recruiting
Falls Church, Virginia, United States, 22042
Australia
Research Site Recruiting
Darlinghurst, New South Wales, Australia, 2010
Research Site Recruiting
East Sydney, New South Wales, Australia, 2010
Research Site Recruiting
Sydney, New South Wales, Australia, 2010
Research Site Recruiting
Fortitude Valley, Queensland, Australia, 4006
Research Site Recruiting
Melbourne, Victoria, Australia, 3004
Research Site Recruiting
Prahran, Victoria, Australia, 3181
Belgium
Research Site Recruiting
Antwerp, Belgium, 2000
Research Site Recruiting
Brussels, Belgium, 1000
Research Site Recruiting
Gent, Belgium, 9000
Canada
Research Site Recruiting
Calgary, Alberta, Canada, T2R 0X7
Research Site Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Research Site Recruiting
Hamilton, Ontario, Canada, L8S 1A4
Research Site Recruiting
Quebec, Canada, G1V 4G2
France
Research Site Recruiting
Bordeaux, France, 33075
Research Site Recruiting
Lyon cedex 04, France, 69317
Research Site Recruiting
Montpellier cedex 5, France, 34295
Research Site Recruiting
Nantes Cedex 1, France, 44093
Research Site Recruiting
Paris Cedex 12, France, 75571
Research Site Recruiting
Paris Cedex 13, France, 75651
Greece
Research Site Recruiting
Athens, Greece, 10676
Research Site Recruiting
Athens, Greece, 11527
Research Site Recruiting
Athens, Greece, 12462
Research Site Recruiting
Athens, Greece, 16121
Research Site Recruiting
Thessaloniki, Greece, 54636
Italy
Research Site Recruiting
Bologna, Italy, 40138
Research Site Recruiting
Genova, Italy, 16132
Research Site Recruiting
Modena, Italy, 41100
Research Site Recruiting
Roma, Italy, 00149
Poland
Research Site Recruiting
Bydgoszcz, Poland, 85-030
Research Site Recruiting
Krakow, Poland, 31-531
Research Site Recruiting
Wroclaw, Poland, 50-136
Portugal
Research Site Recruiting
Aveiro, Portugal, 3814-501
Research Site Recruiting
Coimbra, Portugal, 3000-075
Research Site Recruiting
Porto, Portugal, 4200-319
Romania
Research Site Recruiting
Bucharest, Romania, 021105
Research Site Recruiting
Constanta, Romania, 900708
Research Site Recruiting
Timisoara, Romania, 300310
South Africa
Research Site Recruiting
Bloemfontein, South Africa, 9301
Spain
Research Site Recruiting
Barcelona, Cataluña, Spain, 08035
Research Site Recruiting
Barcelona, Cataluña, Spain, 08036
Research Site Recruiting
Madrid, Spain, 28040
Research Site Recruiting
Madrid, Spain, 28046
Switzerland
Research Site Recruiting
Geneva 14, Switzerland, 1211
Research Site Recruiting
Lausanne, Switzerland, 1011
Research Site Recruiting
Lugano, Switzerland, 6900
Research Site Recruiting
Zuerich, Switzerland, 8091
United Kingdom
Research Site Recruiting
London, United Kingdom, SE1 9RT
Research Site Recruiting
London, United Kingdom, SW10 9NH
Research Site Recruiting
London, United Kingdom, W2 1NY

Sponsors and Collaborators

Amgen

Investigators

Study Director: MD Amgen
More Information

More Information

Additional Information:

AmgenTrials clinical trials website

Responsible Party: Amgen  
ClinicalTrials.gov Identifier: NCT02833844   History of Changes  
Other Study ID Numbers: 20130286  
  2015-004735-12  
Study First Received: June 13, 2016  
Last Updated: November 9, 2017  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Amgen:

Hyperlipidemia
Dyslipidemia
Proprotein convertase subtilisin/kexin type 9 (PCSK9)
Inhibition
HIV infection
Cluster of differentiation
Viral load

Additional relevant MeSH terms:
HIV Infections
Dyslipidemias
Hyperlipidemias
Hyperlipoproteinemias
Antibodies, Monoclonal

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.