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EPIC-HIV
NCT03207945Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2018
- Primary completion
- Aug 2025
- Countries
- 1
- Sponsor
- University of California, San Francisco
- Modality
- Monoclonal Antibodies
- Drugs
- alirocumab
- Conditions
- cardiovascular disease (CVD)dyslipidemia
01
Overview
Phase 3, randomised, double-blind trial in cardiovascular disease (CVD) and dyslipidemia comparing Alirocumab with Placebo (2 arms). Primary endpoint: Arterial Inflammation assessed by FDG-PET/CT at 52 weeks. Started Apr 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Alirocumab
Alirocumab 75 mg every two weeks, upwardly titrated to 150 mg if LDL ≥ 50 mg/dL at week 4.
Placebo
Placebo administered once every two weeks.
03
Who it enrols
HIV-infected adults ≥40 years on continuous ART with suppressed viral load, moderate or high CVD risk, and elevated LDL-C.
04
Endpoints
Primary
Arterial Inflammation assessed by FDG-PET/CT
Secondary
Flow mediated vasodilation of the brachial artery
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