NCT07892664Not yet recruitingPhase 2/3
Reducing Arterial Inflammation Using Eplerenone and Statins in HIV
Study to Understand the Reduction in Arterial Inflammation Combining Statins and Eplerenone
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 18 Oct 2026
- Start date
- 1 Mar 2027
- Primary completion date
- 31 May 2031
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT07892664
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 124
- From 1 Mar 2027 to the primary completion date, 31 May 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4 and CYP3A4 inducers (boosting doses of ritonavir 100mg are allowed);
- Steroids or other anti-inflammatory agents within last 1 month; NSAIDs are allowed;
- Significant radiation exposure from clinical or research scans, cumulative exposure ≥25mSv over 12 months is not allowed;
Other illness
- Known Addison's disease
- Active infection (besides HIV);
- Iodine contrast allergy;
Lab values
- Use of potassium (K) supplements;
- Use of potassium-sparing diuretic;
- 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;
- Hemoglobin\<10.0 g/dL;
Other
- MRA use within the last 90 days;
- Known HFrEF or primary aldosteronism;
- Newly initiated GLP1-RA or anti-hypertensive within 90 days, stable use \>90 days is allowed;
- SBP\<90mmHg;
- K\>5.5 mEq/L;
- Pregnant, seeking pregnancy, breastfeeding;
- Known severe coronary artery stenosis, defined as ≥50% stenosis in the left main coronary artery or \>70% stenosis
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| UCLA Center for Clinical AIDS Research and Education (CARE) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.