NCT07892664

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
52mo left

Started Mar 2027

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2031

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

4.3 years

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

HIV (Human Immunodeficiency Virus)Cardiovascular Diseases (CVD)Arterial InflammationHeart Disease

Keywords

HIVCardiovascular DiseaseEplerenoneStatinArterial InflammationHeart DiseaseFDG-PET

Outcome Measures

Primary Outcomes (1)

  • Arterial Inflammation

    Change in target to background ratio (a measure of arterial inflammation) of the index vessel or Change in target to background ratio (a measure of arterial inflammation) of the most diseased segment of the index vessel measured via cardiac positron emission tomography/computed tomography.

    Baseline, 12 Months

Secondary Outcomes (6)

  • Coronary Inflammation

    Baseline, 12 Months

  • Systemic Inflammation

    Baseline, 12 Months

  • 24 hour Ambulatory Blood Pressure Monitoring

    Baseline, 12 Months

  • Non-Calcified Plaque

    Baseline, 12 Months

  • High-Risk Plaque Features

    Baseline, 12 Months

  • +1 more secondary outcomes

Study Arms (2)

Eplerenone

EXPERIMENTAL

Patients randomized into the Eplerenone arm will receive 50 mg administered orally twice a day for 12 months.

Drug: Eplerenone

Placebo

PLACEBO COMPARATOR

Patients randomized into the Placebo arm will receive 50 mg administered orally twice a day for 12 months.

Drug: Placebo

Interventions

EplerenoneDRUG

Eplerenone is an oral mineralocorticoid receptor antagonist, which is currently FDA approved for treatment of hypertension and heart failure. This intervention was chosen based on preliminary data suggesting a benefit on arterial inflammation in HIV. This intervention will be used as add on therapy to background moderate intensity statin to target residual arterial inflammation in HIV. Active study drug will be blinded by the clinical trials pharmacy. Daily dosing starts at 50 mg PO daily for the first week, then will be increased to 50 mg PO twice daily at the 2 week visit. Participants will remain on the 50 mg PO twice daily dosing for a total of 12 months. Dose reductions will occur as outlined in the protocol for hypotension, elevated potassium, and elevated renal function.

Eplerenone
PlaceboDRUG

Identical placebo will be prepared by the Clinical Trials Pharmacy.

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ART use \>12 months;
  • Viral load \<200 copies/mL;
  • Stable use (\>90 days) of moderate-intensity statin (pitavastatin 4mg daily, atorvastatin 10-20mg daily, rosuvastatin 5-10mg daily; simvastatin 20-40mg; pravastatin 40-80mg) or maximally tolerated statin if prior history of statin intolerance;
  • ASCVD risk ≥5%;
  • Baseline TBR≥2.3 on cardiac 18F-FDG-PET

You may not qualify if:

  • MRA use within the last 90 days;
  • Use of potassium (K) supplements;
  • Known HFrEF or primary aldosteronism;
  • Known Addison's disease
  • Use of ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4 and CYP3A4 inducers (boosting doses of ritonavir 100mg are allowed);
  • Use of potassium-sparing diuretic;
  • Steroids or other anti-inflammatory agents within last 1 month; NSAIDs are allowed;
  • Newly initiated GLP1-RA or anti-hypertensive within 90 days, stable use \>90 days is allowed;
  • SBP\<90mmHg;
  • Type 1 DM or poorly controlled type 2 DM with HbA1c\>7.5%;
  • Creatinine (Cr)\>1.5 mg/dL or eGFR\<60mL/min/1.73m²;
  • K\>5.5 mEq/L;
  • Hemoglobin\<10.0 g/dL;
  • Pregnant, seeking pregnancy, breastfeeding;
  • Active infection (besides HIV);
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UCLA Center for Clinical AIDS Research and Education (CARE)

Los Angeles, California, 90095, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Shen G, Thomas TS, Walpert AR, McClure CM, Fitch KV, deFilippi C, Torriani M, Buckless CG, Adler GK, Grinspoon SK, Srinivasa S. Role of renin-angiotensin-aldosterone system activation and other metabolic variables in relation to arterial inflammation in HIV. Clin Endocrinol (Oxf). 2022 Nov;97(5):581-587. doi: 10.1111/cen.14784. Epub 2022 Jun 6.

    PMID: 35614846BACKGROUND

  • Srinivasa S, Abohashem S, Walpert AR, Dunderdale CN, Iyengar S, Shen G, Jerosch-Herold M, deFilippi CR, Robbins GK, Lee H, Kwong RY, Adler GK, Tawakol A, Grinspoon SK. Mineralocorticoid Receptor Antagonism by Eplerenone and Arterial Inflammation in HIV: The MIRABELLA HIV Study. JAMA Cardiol. 2024 Feb 1;9(2):189-194. doi: 10.1001/jamacardio.2023.4578.

    PMID: 38090987BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCardiovascular DiseasesArteritisHeart Diseases

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesVasculitisVascular Diseases

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Suman Srinivasa, MD

CONTACT

617-726-1585ssrinivasa@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 23, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

May 31, 2031

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)