Actively Recruiting
Reducing Systemic Inflammation in People on Antiretroviral Therapy
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-11-19
150
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Reducing Systemic Inflammation in People on Antiretroviral Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 40 years or older, or have lived with HIV for 25 years or more, any sex
- Undetectable HIV viral load (last viral load measurement less than 50 copies/ml within the last 6 months)
- Presence of at least one cardiovascular risk factor such as longstanding HIV infection (25+ years), hypertension, diabetes, past or present smoking, dyslipidemia, family history of early onset cardiovascular disease, or known previous cardiovascular disease
- Participants with past cardiovascular disease must be in stable condition as judged by study clinicians
- Past cardiovascular events must have occurred at least 3 months before screening
- Evidence of detectable plasmatic sgp120 levels at any point in the past year using the specified assay
You will not qualify if you...
- Known allergy to the study drug
- Concomitant treatment with strong cytochrome P450 (CYP3A) inducers such as carbamazepine, phenytoin, mitotane, enzalutamide, rifampicin, and St John's wort
- Planning to become pregnant, pregnant, or breastfeeding; females of childbearing potential must have a negative pregnancy test at baseline and follow contraception during treatment
- Contraindication for CT scan use including low kidney function (eGFR less than 40 ml/min) or iodine allergy
- Elevated risk of prior ionizing radiation exposure exceeding 10 mSV over 3 years
- Confirmed uncorrected QT value above specified thresholds or long QT syndrome
- Current or planned treatment with certain heart rhythm medications such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, sotalol, and quinidine
- Unstable liver disease or severe liver test abnormalities
- History of liver cirrhosis classified as CHILD-PUGH class C
- Inability to provide informed consent
- Life expectancy less than 36 months
- Inability to attend study visits
- Participation in another interventional trial
- Known congestive heart failure with NYHA class 3 or 4
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CR CHUM
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
Research Team
B
Branka Vulesevic, TRIAL MANAGER
CONTACT
M
Madeleine Durand, STUDY SPONSOR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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