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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

Must not have

Subjects who are unable to receive injections, as either a self-injection, or administered by another person

Active phase hepatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 24 and week 52

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

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I am at moderate or high risk for heart disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive injections, either by myself or from someone else.

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I have active hepatitis.

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I am scheduled for or currently undergoing a procedure to remove abnormal cells from my blood.

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I am not currently participating in any studies with experimental drugs.

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I need insulin every day.

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My heart's pumping ability is severely reduced.

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My high blood pressure is not well-managed.

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

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

FDG PET/CT Endpoint

Secondary study objectives

Flow mediated vasodilation of the brachial artery (FMD) endpoint

Other study objectives

Coronary CTA Endpoint

Side effects data

From 2017 Phase 3 trial • 233 Patients • NCT02023879

19%

Viral upper respiratory tract infection

15%

Back pain

15%

Injection site reaction

10%

Oedema peripheral

10%

Bronchitis

10%

Urinary tract infection

Upper respiratory tract infection

Influenza

Headache

Dizziness

Osteoarthritis

Arthralgia

Hyperkalaemia

Nausea

Fatigue

Pneumonia

Hypertension

Diarrhoea

Syncope

Musculoskeletal pain

Fall

Rhabdomyolysis

Rash

Cough

Breast cancer

Peripheral artery stenosis

Faecaloma

Myalgia

Chronic obstructive pulmonary disease

Sinusitis

Cellulitis

Pain in extremity

Lumbar spinal stenosis

Gout

Atrial fibrillation

Non-cardiac chest pain

Cerebellar infarction

Basal cell carcinoma

Mental disorder

Jaw fracture

Arthritis

Musculoskeletal chest pain

Muscle spasms

Small intestinal obstruction

Hypoxic-ischaemic encephalopathy

Coronary artery disease

Cardio-respiratory arrest

100%

80%

60%

40%

20%

Study treatment Arm

Alirocumab 150 mg Q4W (After Alirocumab 150 Q4W/Up150 Q2W)

Placebo Q2W

Alirocumab 75 mg Q2W/Up150 mg Q2W

Alirocumab 150 mg Q4W/Up150 mg Q2W

Alirocumab 150 mg Q4W (After Placebo Q2W)

Alirocumab 150 mg Q4W (After Alirocumab 75 Q2W/Up150 Q2W)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 9Eligibility criteria met