Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05488431
Registration number
NCT05488431
Ethics application status
Date submitted
25/07/2022
Date registered
4/08/2022
Date last updated
3/07/2023
Titles & IDs
Public title
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Query!
Scientific title
Cholesterol and Inflammation Lowering Via Bempedoic Acid, an ACL-inhibiting Regimen in HIV Trial (CLEAR HIV Trial)
Query!
Secondary ID [1]
0
0
1.0
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Cardiovascular
0
0
0
0
Query!
Diseases of the vasculature and circulation including the lymphatic system
Query!
Cardiovascular
0
0
0
0
Query!
Other cardiovascular diseases
Query!
Blood
0
0
0
0
Query!
Other blood disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Bempedoic acid
Other interventions - Placebo
Experimental: Bempedoic acid (BA) - Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks.
Placebo Comparator: Placebo - Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks.
Treatment: Drugs: Bempedoic acid
Bempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in >4300 individuals and is currently being studied in >14,000 individuals in CLEAR Outcomes (NCT02993406).
Other interventions: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
FDG PET/CT Endpoint
Query!
Assessment method [1]
0
0
Change in Target-to-background ratio from baseline to follow-up study at 52 weeks. The main arterial endpoint is the most diseased segment of the index vessel. These findings will be correlated to measurements in the secondary endpoint.
Query!
Timepoint [1]
0
0
Baseline and Week 52
Query!
Secondary outcome [1]
0
0
Total Cholesterol Endpoint
Query!
Assessment method [1]
0
0
Change in total cholesterol will be assessed from baseline to week 24 and week 52.
Query!
Timepoint [1]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [2]
0
0
HDL Endpoint
Query!
Assessment method [2]
0
0
Change in HDL will be assessed from baseline to week 24 and week 52.
Query!
Timepoint [2]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [3]
0
0
LDL Endpoint
Query!
Assessment method [3]
0
0
Change in LDL will be assessed from baseline to week 24 and week 52.
Query!
Timepoint [3]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [4]
0
0
Triglycerides Endpoint
Query!
Assessment method [4]
0
0
Change in triglycerides will be assessed from baseline to week 24 and week 52.
Query!
Timepoint [4]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [5]
0
0
Apolipoprotein B Endpoint
Query!
Assessment method [5]
0
0
Change in apolipoprotein B will be assessed from baseline to week 24 and week 52.
Query!
Timepoint [5]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [6]
0
0
Hb A1c Endpoint
Query!
Assessment method [6]
0
0
Change in HbA1c from baseline to week 24 and week 52.
Query!
Timepoint [6]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [7]
0
0
Fasting glucose Endpoint
Query!
Assessment method [7]
0
0
Change in fasting glucose measurements from baseline to week 24 and week 52.
Query!
Timepoint [7]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [8]
0
0
Insulin Endpoint
Query!
Assessment method [8]
0
0
Change in insulin measurements from baseline to week 24 and week 52.
Query!
Timepoint [8]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [9]
0
0
homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Endpoints
Query!
Assessment method [9]
0
0
The change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), a calculation based on insulin and glucose, will also be assessed from baseline to week 24 and 52.
The equation simplifies to [HOMA-IR = fasting insulin *fasting glucose /22.5] where fasting plasma insulin is measured in (µIU/mL) and fasting plasma glucose is measured in (mmol/L). Values below 1.0 are generally considered optimal.
Query!
Timepoint [9]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [10]
0
0
Adipose Volume Endpoint
Query!
Assessment method [10]
0
0
Change in adipose tissue volumes will be assessed by FDG PET/CT (as measured in primary outcome) from baseline to week 52.
Query!
Timepoint [10]
0
0
Baseline and Week 52
Query!
Secondary outcome [11]
0
0
hsCRP Endpoint
Query!
Assessment method [11]
0
0
Change in hsCRP from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [11]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [12]
0
0
IL-1B Endpoint
Query!
Assessment method [12]
0
0
Change in IL-1B from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [12]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [13]
0
0
IL-18 Endpoint
Query!
Assessment method [13]
0
0
Change in IL-18 from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [13]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [14]
0
0
SAA Endpoint
Query!
Assessment method [14]
0
0
Change in SAA from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [14]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [15]
0
0
Lp-PLA2 Endpoint
Query!
Assessment method [15]
0
0
Change in Lp-PLA2 from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [15]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [16]
0
0
sCD163 Endpoint
Query!
Assessment method [16]
0
0
Change in sCD163 from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [16]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [17]
0
0
IL-6 Endpoint
Query!
Assessment method [17]
0
0
Change in IL-6 from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [17]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [18]
0
0
D-Dimer Endpoint
Query!
Assessment method [18]
0
0
Change in D-Dimer from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [18]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [19]
0
0
Fibrinogen Endpoint
Query!
Assessment method [19]
0
0
Change in fibrinogen from baseline to follow-up at weeks 24 and 52.
Query!
Timepoint [19]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [20]
0
0
T-cell Endpoint
Query!
Assessment method [20]
0
0
Change in T-cell marker from baseline to follow up at weeks 24 and 52.
Query!
Timepoint [20]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [21]
0
0
B-cell Endpoint
Query!
Assessment method [21]
0
0
Change in B-cell marker from baseline to follow up at weeks 24 and 52.
Query!
Timepoint [21]
0
0
Baseline, Week 24 and Week 52
Query!
Secondary outcome [22]
0
0
Monocyte activation Endpoint
Query!
Assessment method [22]
0
0
Change in monocyte activation marker from baseline to follow up at weeks 24 and 52.
Query!
Timepoint [22]
0
0
Baseline, Week 24 and Week 52
Query!
Eligibility
Key inclusion 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 = 70 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 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)
- 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 individuals will have lower TBRs, it is rare
that an HIV infected individual will fall below this range.
- Female subjects 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 at least one month
following study completion and have a negative pregnancy test at screening and prior
to the first dose of drug.
- Males must use at least one method of contraception throughout the study.
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/03/2028
Query!
Actual
Query!
Sample size
Target
121
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Priscilla Hsue, MD
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05488431
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Priscilla Hsue, MD
Query!
Address
0
0
University of California, San Francisco
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Marta Levkova
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
628-206-8037
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/ct2/show/NCT05488431
Download to PDF