Eplerenone + Statins for Heart Disease in HIV

(SUNRISE HIV Trial)

Not yet recruiting at 1 trial location
SS
Overseen BySuman Srinivasa, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Massachusetts General Hospital
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

HIV has transitioned to a chronic disease in which well-treated persons remain at higher risk for heart disease when compared to the general population. Statin medications have been shown to reduce the number of events related to heart disease, but there are still individuals who will have complications from heart disease despite statin use. This study is being conducted to determine whether adding on another medication to statins called eplerenone, which has been shown to reduce inflammation in the heart vasculature among persons with HIV, can further decrease the risk of heart disease in HIV through its anti-inflammatory and blood pressure-lowering potential.

Are You a Good Fit for This Trial?

This trial is for people living with HIV who are already taking statins to lower cholesterol but still have a higher risk of heart disease. Participants should not have conditions or be on medications that would make eplerenone unsafe for them.

Inclusion Criteria

ASCVD risk greater than or equal to 5%
Viral load less than 200 copies/mL
I have been on antiretroviral therapy for over 12 months.
See 2 more

Exclusion Criteria

I have been diagnosed with Addison's disease.
Systolic blood pressure less than 90 mmHg
Hemoglobin less than 10.0 g/dL
See 15 more

What Are the Treatments Tested in This Trial?

Interventions

  • Eplerenone

Trial Overview

The study tests if adding eplerenone (a blood pressure and anti-inflammatory drug) to standard statin therapy can further reduce inflammation in the arteries compared to a placebo, using a randomized design.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: EplerenoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

University of California, Los Angeles (UCLA Health)

Collaborator