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Monoclonal Antibodies
PCSK9 Inhibition for HIV-Related Cardiovascular Risk (EPIC-HIV Trial)
Phase 3
Recruiting
Led By Priscilla Hsue, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females equal or greater than 40 years of age
Moderate or high CVD risk as defined by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24 and week 52
Awards & highlights
EPIC-HIV Trial Summary
This trial will study whether a drug that lowers cholesterol can also reduce inflammation and improve endothelial function in people with HIV.
Who is the study for?
This trial is for men and women over 40 with HIV, on stable antiretroviral therapy (ART) for at least 12 weeks, who have cardiovascular disease (CVD) or are at risk. They should not have had recent changes in heart or cholesterol medications, severe heart failure, uncontrolled blood pressure, certain medical conditions including recent cancer, or be pregnant. Participants must also have controlled HIV viral loads and meet specific criteria for cholesterol levels.Check my eligibility
What is being tested?
The EPIC-HIV Study tests whether a drug called alirocumab can reduce vascular inflammation and improve endothelial function in people with treated HIV infection compared to a placebo. The study will use advanced imaging techniques to assess the effects of PCSK9 inhibition on arterial inflammation and non-calcified plaque in participants' arteries.See study design
What are the potential side effects?
Alirocumab may cause side effects like injection site reactions, flu-like symptoms, muscle pain or weakness, allergic reactions such as rash or swelling. It's generally well-tolerated but monitoring is necessary due to potential immune system impacts.
EPIC-HIV Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years old or older.
Select...
I am at moderate or high risk for heart disease.
EPIC-HIV Trial 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
FDG PET/CT Endpoint
Secondary outcome measures
Flow mediated vasodilation of the brachial artery (FMD) endpoint
Other outcome measures
Coronary CTA Endpoint
Side effects data
From 2017 Phase 3 trial • 233 Patients • NCT0202387915%
Viral upper respiratory tract infection
13%
Fall
10%
Diarrhoea
9%
Back pain
8%
Upper respiratory tract infection
8%
Hypertension
8%
Influenza
8%
Cough
7%
Urinary tract infection
7%
Fatigue
7%
Osteoarthritis
7%
Arthralgia
7%
Injection site reaction
7%
Depression
6%
Musculoskeletal pain
6%
Myalgia
6%
Headache
5%
Non-cardiac chest pain
5%
Oedema peripheral
5%
Dizziness
5%
Gout
4%
Muscle spasms
4%
Bronchitis
3%
Nausea
3%
Rash
3%
Laceration
3%
Acute myocardial infarction
3%
Syncope
3%
Pain in extremity
3%
Sinusitis
2%
Cardiac failure congestive
2%
Basal cell carcinoma
2%
Presyncope
2%
Hypotension
2%
Coronary artery disease
2%
Prostate cancer
1%
Femur fracture
1%
Retinal detachment
1%
Hypovolaemic shock
1%
Small intestinal obstruction
1%
Pharyngitis
1%
Arachnoiditis
1%
Device related infection
1%
Myocardial infarction
1%
Retroperitoneal haematoma
1%
Gastrointestinal haemorrhage
1%
Basedow's disease
1%
Vertigo
1%
Intentional overdose
1%
Bladder transitional cell carcinoma
1%
Post procedural haematoma
1%
Suicide attempt
1%
Haemorrhagic anaemia
1%
Abdominal pain
1%
Cerebrovascular accident
1%
Hyperkalaemia
1%
Aortic valve stenosis
1%
Abdominal wall haematoma
1%
Chest pain
1%
Cholelithiasis
1%
Pneumonia
1%
Subdural haematoma
1%
Vascular pseudoaneurysm
1%
Spinal osteoarthritis
1%
Skin cancer
1%
Multiple sclerosis relapse
1%
Transient ischaemic attack
1%
Haematoma
1%
Peripheral ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)
Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)
Alirocumab 150 mg Q4W/Up150 mg Q2W
Alirocumab 75 mg Q2W/Up150 mg Q2W
Placebo Q2W
Alirocumab 150 mg Q4W (After Placebo Q2W)
EPIC-HIV Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AlirocumabExperimental Treatment1 Intervention
Patients randomized into the alirocumab arm will start off with 75 mg alirocumab administered every two weeks for two doses and will be upwardly titrated to 150 mg alirocumab if subjects demonstrate LDL ≥ 50 mg/dL at week 4. Subjects demonstrating LDL-C <50mg/dl will remain on the same 75mg dose throughout the trial.
Group II: PlaceboPlacebo Group1 Intervention
Patients randomized into the placebo arm will receive 75 mg or 150 mg or placebo administered once every two weeks throughout the trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alirocumab
2012
Completed Phase 3
~23510
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,415 Total Patients Enrolled
Massachusetts General HospitalOTHER
2,929 Previous Clinical Trials
13,198,165 Total Patients Enrolled
Priscilla Hsue, MDPrincipal Investigator - University of California, San Francisco
San Francisco General Hospital, University of California SFGH Medical Group
University Of California (Medical School)
University Ca Sf School Of Medicine (Residency)
12 Previous Clinical Trials
1,721 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to change my HIV treatment within the next year.You have a certain number of CD4 T cells in your blood.I cannot receive injections, either by myself or from someone else.I have not had a stroke, thyroid issues, alcohol or drug problems, or cancer in the last 5 years.I haven't changed my cholesterol or blood pressure medication in the last 3 months.I have had a heart or stroke event or procedure in the last 3 months.Your cholesterol and other fat levels will be checked before you can join the study.Your liver function test results must meet specific requirements.I have active hepatitis.I am 40 years old or older.I am willing and able to follow the study's schedule and procedures.I am at moderate or high risk for heart disease.I am scheduled for or currently undergoing a procedure to remove abnormal cells from my blood.I am not currently participating in any studies with experimental drugs.Your kidney function test result needs to meet specific requirements.I need insulin every day.I have been on the same HIV medication for at least 12 weeks.You have a confirmed HIV infection.My heart's pumping ability is severely reduced.I am not using, or willing to use, effective birth control and am not sterilized or postmenopausal.Your HIV virus level has been very low for at least 12 weeks before joining the study.Criterion: Additional rules for who cannot have the FDG-PET/CT imaging.You have had a serious allergic reaction to a specific type of medication that is made from antibodies.I meet the criteria for statin therapy and have been on a stable dose for at least 4 weeks.Your blood tests, body chemistry, or heart test results are not normal and could be a problem.I haven't started or changed any non-lipid lowering meds or supplements in the last 6 weeks.My high blood pressure is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Alirocumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What are the potential side-effects of Alirocumab?
"There is both efficacy and safety data available for Alirocumab, which has been collected over multiple Phase 3 trials. Consequently, it received a score of 3 from our team."
Answered by AI
Are there other scientific investigations that have utilized Alirocumab?
"There are a total of 10 clinical trials being conducted for Alirocumab. 1 of those is in Phase 3 and the rest are in earlier stages. Most of the research centres conducting these studies are based in Chicago, but there are also12 other locations running similar investigations."
Answered by AI
How many people are being asked to participate in this clinical trial?
"That is correct. The clinical trial in question, which can be found on clinicaltrials.gov, is still recruiting patients. It was first posted on April 30th, 2018 and was edited most recently on April 25th, 2022. There is a total of 140 patients that need to be recruited for the 1 location involved in the trial."
Answered by AI
What medical conditions is Alirocumab most often prescribed for?
"Alirocumab is frequently used to help patients that have had a myocardial infarction, however it can also be given as treatment for conditions such as hypercholesterolemia and unstable angina pectoris."
Answered by AI
Are investigators currently looking for new participants?
"That is correct. The clinicaltrial.gov website has the most recent information on this study, which is recruiting for 140 participants at 1 locations."
Answered by AI
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