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ACL-inhibiting Regimen

Bempedoic Acid for HIV-Related Cardiovascular Disease

Phase 2
Recruiting
Research Sponsored by Priscilla Hsue, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Documented cardiovascular disease as defined by: 1. Prior myocardial infarction, 2. Prior cerebrovascular disease, 3. Prior peripheral arterial disease, 4. History of percutaneous coronary intervention, 5. History of coronary artery bypass graft OR 6. Angiographic evidence of >50% stenosis in at least one coronary artery OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
Male or female between the ages ≥ 40 years of age
Must not have
Acute systemic infection within 30 days
Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24 and week 52

Summary

This trial will study the effect of Bempedoic acid (BA) on safety, arterial inflammation, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in HIV-infected individuals aged ≥40 years with known CVD or 1 CVD risk factor.

Who is the study for?
This trial is for HIV-infected individuals aged ≥40 with controlled infection and either known cardiovascular disease or one risk factor. Participants must have a CD4 count ≥200 cells/mm3, LDL-C ≥70 mg/dL, and agree to contraception if applicable. Exclusions include pregnancy, certain liver enzyme levels, severe kidney dysfunction, anemia, uncontrolled hypertension, recent acute infections, specific blood cell count abnormalities, very high triglycerides at screening or insulin-treated diabetes.
What is being tested?
The CLEAR HIV Trial is testing the safety and effects of Bempedoic acid on arterial inflammation (measured by FDG-PET/CT), cholesterol levels (lipids), immune activation and non-calcified plaque in coronary arteries among treated HIV patients with cardiovascular risks. It's a randomized study comparing Bempedoic acid against a placebo.
What are the potential side effects?
Potential side effects of Bempedoic acid may include muscle pain or weakness (myopathy), increased liver enzymes which could indicate liver problems. Since it's being compared to a placebo any additional side effects will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a history of heart disease or risk factors for it.
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I am 40 years old or older.
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I have been diagnosed with HIV.
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I am a woman not able to have children or will use two forms of birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a serious infection in the last 30 days.
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I take insulin for my diabetes.
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My kidney function is severely impaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24 and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fluorodeoxyglucose F18
Secondary study objectives
Adipose Volume Endpoint
Apolipoproteins B
B-cell Endpoint
+19 more
Other study objectives
Coronary CTA Coronary Plaque Incidence Endpoint
Coronary CTA High-risk Plaque Endpoint
Coronary CTA Non-calcified Plaque Endpoint

Side effects data

From 2018 Phase 3 trial • 269 Patients • NCT03001076
8%
Blood uric acid increase
4%
Headache
4%
Liver function test increased
3%
Urinary tract infection
3%
Nausea
3%
Muscle spasms
3%
Sinusitis
2%
Nasopharyngitis
2%
Myalgia
2%
Glomerular filtration rate decreased
1%
Hepatic cancer
1%
Syncope
1%
Dysuria
1%
Osteoarthritis
1%
Intestinal obstruction
1%
Diabetes mellitus
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Bempedoic Acid

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bempedoic acid (BA)Experimental Treatment1 Intervention
Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempedoic acid
2016
Completed Phase 3
~270

Find a Location

Who is running the clinical trial?

University of UtahOTHER
1,147 Previous Clinical Trials
1,699,500 Total Patients Enrolled
University of California, Los AngelesOTHER
1,568 Previous Clinical Trials
10,314,151 Total Patients Enrolled
Priscilla Hsue, MDLead Sponsor
3 Previous Clinical Trials
77 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,699 Total Patients Enrolled

Media Library

Bempedoic acid (ACL-inhibiting Regimen) Clinical Trial Eligibility Overview. Trial Name: NCT05488431 — Phase 2
Human Immunodeficiency Virus Infection Research Study Groups: Bempedoic acid (BA), Placebo
Human Immunodeficiency Virus Infection Clinical Trial 2023: Bempedoic acid Highlights & Side Effects. Trial Name: NCT05488431 — Phase 2
Bempedoic acid (ACL-inhibiting Regimen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488431 — Phase 2
~77 spots leftby Mar 2028
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