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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24 and week 52
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24 and week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24 and week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fluorodeoxyglucose F18
Secondary outcome measures
Adipose Volume Endpoint
Apolipoproteins B
B-cell Endpoint
+19 moreOther outcome measures
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 • NCT030010768%
Blood uric acid increase
4%
Headache
4%
Liver function test increased
3%
Muscle spasms
3%
Nausea
3%
Urinary tract infection
3%
Sinusitis
2%
Myalgia
2%
Nasopharyngitis
2%
Glomerular filtration rate decreased
1%
Intestinal obstruction
1%
Hepatic cancer
1%
Syncope
1%
Dysuria
1%
Bronchitis
1%
Osteoarthritis
1%
Diabetes mellitus
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
1,099 Previous Clinical Trials
1,778,568 Total Patients Enrolled
University of California, Los AngelesOTHER
1,530 Previous Clinical Trials
10,264,587 Total Patients Enrolled
Priscilla Hsue, MDLead Sponsor
3 Previous Clinical Trials
77 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your carotid artery or aorta has too much inflammation. This helps make sure that only people with enough inflammation can join the study.I will use contraception during the study.I have not had a serious infection in the last 30 days.I am 40 years old or older.I take insulin for my diabetes.I am taking simvastatin over 20mg or pravastatin over 40mg.I have a history of heart disease or risk factors for it.Your white blood cell count, platelet count, or absolute neutrophil count is too low.I have been diagnosed with HIV.You have low levels of hemoglobin, which is a protein in your blood.Your CD4 T-cell count is at least 200 cells per cubic millimeter.I have been on HIV medication for 12 weeks or more and my HIV is under control.Your blood pressure is not well controlled, and it is very high.Your liver enzymes are more than twice the normal level.I am a woman not able to have children or will use two forms of birth control during the study.My kidney function is severely impaired.Your LDL cholesterol is higher than 70 mg/dL.Your triglyceride levels are higher than 500 mg/dL when tested before the trial.I have not had cancer in the last 5 years, except for skin cancer.You are pregnant or breastfeeding, since there is no information about how the study drug bempedoic acid might affect you or your baby.
Research Study Groups:
This trial has the following groups:- Group 1: Bempedoic acid (BA)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any reported dangers of Bempedoic acid?
"Bempedoic acid has a Phase 3 clinical trial classification, meaning that there is some data to support both its efficacy and safety. Our team rates it as a 3 on our 1-to-3 scale."
Answered by AI
Are people enrolling in this clinical trial as of now?
"This particular trial is not currently recruiting patients, as seen on clinicaltrials.gov. The study was posted December 1st, 2022 and last edited on August 3rd, 2022; however, there are 1419 other trials active right now that are looking for volunteers."
Answered by AI
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