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

Conditions

• Subjects With Hyperlipidemia, Dyslipidemia and HIV Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Evolocumab — DRUG
  Dose of subcutaneous evolocumab QM
• Placebo — DRUG
  Dose of matching placebo QM

Study Details

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.

Key Dates

Start date

May 22, 2017

Status verified

Jul 2022

Primary completion

Jul 9, 2019

Completion

Jan 27, 2020

Study Design

Enrollment

467 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-Blind Placebo SC QM/Open-Label Evolocumab 420 mg SC QM
  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.
• Placebo Comparator: Double-Blind Evolocumab 420 mg SC QM/Open-Label Evolocumab 420 mg SC QM
  Double-blind evolocumab SC injection QM for 24 weeks, followed by open-label evolocumab 420 mg SC QM for 24 weeks.

Primary Outcome Measure

Percent Change From Baseline in LDL-C at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (20)

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