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Completed

NCT Number: NCT02833844

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

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.

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Key information

Conditions

Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection Behavior Blood-Borne Infections Communicable Diseases Dyslipidemias Genital Diseases HIV Infections Hypercholesterolemia, Autosomal Dominant, 3 Hyperlipidemias Immune System Diseases Immunologic Deficiency Syndromes Infections Inhibition, Psychological Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evolocumab

Drug

Dose of subcutaneous evolocumab QM

Other names: EvoMab, Repatha, AMG 145

Placebo

Drug

Dose of matching placebo QM

Primary outcomes

  1. 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.)

Secondary outcomes

  1. 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.)

  2. Percentage of Participants Acheiving LDL-C < 70 mg/dL (1.8 mmol/L) at Week 24

    Time frame: Week 24

  3. Percentage of Participants With an LDL-C Response (50% Reduction of LDL-C From Baseline) at Week 24

    Time frame: Baseline, Week 24

  4. Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (HDL-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.)

  5. Percent Change From Baseline in Apolipoprotein B (ApoB) 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.)

  6. Percent Change From Baseline in Total Cholesterol (TC) 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.)

  7. Percent Change From Baseline in Lipoprotein(a) (Lp[a]) 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.)

  8. Percent Change From Baseline in Triglycerides 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.)

  9. Percent Change From Baseline in HDL-C at Week 24

    Time frame: Bseline, 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. Percent Change From Baseline in Very Low-Density Lipoprotein Cholesterol (VLDL-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.)

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 14, 2016
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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