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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 467 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection

Interventions

Type	Name	Description
DRUG	Evolocumab	Dose of subcutaneous evolocumab QM
DRUG	Placebo	Dose of matching placebo QM

Timeline

• Start date: 2017-05-22
• Primary completion: 2019-07-09
• Completion: 2020-01-27
• First posted: 2016-07-14
• Last updated: 2022-07-22
• Results posted: 2020-07-21

Locations

78 sites across 15 countries: United States, Australia, Belgium, Brazil, Canada, France, Greece, Italy, Poland, Portugal, Romania, South Africa, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study