RecruitingPhase 2NCT07030920

Reducing Systemic Inflammation in People on Antiretroviral Therapy


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

150 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This randomized, open-label clinical trial will evaluate whether adding fostemsavir to current antiretroviral therapy can reduce the risk of cardiovascular disease in people with well-controlled HIV. Researchers will compare imaging, clinical and biomarker outcomes between participants who receive fostemsavir in addition to their existing treatment and those who continue with standard care alone.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a treatment can reduce persistent inflammation in people living with HIV who are on suppressive antiretroviral therapy (ART), which may lower their risk of heart disease and other complications. **You may be eligible if:** - You are living with HIV and are 40 or older, OR have lived with HIV for 25 or more years - Your HIV is undetectable (viral load under 50 copies/mL in the last 6 months) - You have at least one cardiovascular risk factor (such as high blood pressure, diabetes, smoking history, high cholesterol, or prior heart disease) - Lab tests show detectable levels of a specific inflammatory protein (sgp120) in the past year **You may NOT be eligible if:** - You have a known allergy to the study drug - You have severe liver disease or heart failure - You are pregnant or planning to become pregnant - You are taking certain medications (such as rifampicin, carbamazepine, or St. John's Wort) that interact with the study drug - You have a heart rhythm abnormality (prolonged QT interval) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFostemsavir

Addition of fostemsavir to the patient's current antiretroviral regimen: once daily oral administration (Rukobia 600 mg extended-release tablets) for 24 months


Locations(1)

CR CHUM

Montreal, Quebec, Canada

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NCT07030920


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