Recruiting

Testing a new cholesterol and inflammation-lowering medication in people with HIV

Plain-English translation of NCT05488431 on ClinicalTrials.gov ↗ · Source last updated December 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a medication called to see if it can help people living with HIV reduce their risk of heart disease. People with HIV face a higher risk of heart problems, even when their HIV is well-controlled. This study will measure whether the medication can lower cholesterol, reduce inflammation in the arteries, and improve other heart health markers over one year.

People living with HIV are twice as likely to develop heart disease as those without HIV, even with modern HIV treatment. Researchers believe this medication could help address this serious health gap by lowering both cholesterol and inflammation at the same time.

Do you qualify?

You likely qualify if…

you are living with HIV that has been well-controlled with antiretroviral therapy for at least 12 weeks
you are 40 years of age or older
you have a history of heart disease (such as a heart attack, stroke, or blocked arteries) or at least one risk factor for heart disease (such as diabetes, high blood pressure, high cholesterol, or a family history of heart disease)
you have measurable inflammation in your arteries, confirmed by a baseline imaging scan
you are willing to use effective birth control throughout the study if you are able to become pregnant

You likely don't qualify if…

you are pregnant or breastfeeding
you have diabetes that requires insulin injections
you have uncontrolled high blood pressure (160 mmHg systolic or higher, or 100 mmHg diastolic or higher)
you have been diagnosed with cancer within the last 5 years (except for minor skin cancers)
you have severe kidney disease or liver disease

What participation looks like

If you join this study, you will be randomly assigned to take either the medication or a placebo (a dummy pill) once daily by mouth for 52 weeks. You will visit the research clinic multiple times for blood tests, heart imaging scans (including PET scans and CT scans), and blood pressure checks to measure how the medication affects your cholesterol, inflammation, and heart health. The study takes place at centers in California, with specialized imaging support from partners in Boston.

AI-generated summary from trial data · Jun 26, 2026 · Not medical advice

Trial locations(3 sites)

United States

UCLA Center for Clinical AIDS Research and Education (CARE), Los Angeles, California

San Francisco General Hospital, San Francisco, California

UT Health Houston, Houston, Texas