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New treatment option for Dyslipidemias
Official title Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
ClinicalTrials.gov ID: NCT05488431
What this study is testing
What is Bempedoic acid?
Bempedoic acid is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dyslipidemias.
Also referred to as BA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count ≥ 200 cells/mm3
- Male or female between the ages ≥ 40 years of age
- LDL-C ≥ 50 mg/dL
You likely can't join if
- Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
- Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
- Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with...
- AST/ALT or alkaline phosphatase \>2x ULN
- Triglycerides \>500 mg/dL at screening
- Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
See the full eligibility criteria
- Documented HIV infection
- On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
- CD4 T-cell count ≥ 200 cells/mm3
- Male or female between the ages ≥ 40 years of age
- LDL-C ≥ 50 mg/dL
- 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...
- TBR of \>1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected...
- Female people must either be of non-childbearing potential (defined as post-menopausal or amenorrhea \> 12 months) or agree to use two forms of contraception (one hormonal and one barrier) throughout the study and for...
- Males must use at least one method of contraception throughout the study.
- Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
- Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
- Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)
- AST/ALT or alkaline phosphatase \>2x ULN
- Triglycerides \>500 mg/dL at screening
- Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
- Individuals on simvastatin \>20mg or pravastatin \>40mg. All other dosages and statins will be permitted with close monitoring for myopathies including assessment of CK levels
- Nephrotic syndrome or eGFR \<30 mL/min/1.73m2
- Cytopenias which include 1) WBC \<3.5 x103/uL 2) Platelet \<120 x103/uL 3) ANC \<1.5 x103/uL, and absolute lymphocytes \<0.8 x 103/uL
- Anemia as fined by Hgb \<10 g/dL
- Acute systemic infection within 30 days
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.