Reducing Systemic Inflammation in People on Antiretroviral Therapy
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.
• 40 years or older, or have lived with HIV for 25 years or more, any sex;
• Undetectable HIV viral load (defined as last viral load measurement less than 50 copies/ml within the last 6 months);
• Presence of at least one cardiovascular risk factor among the following: longstanding HIV infection (25 years or more), hypertension, diabetes, past or present smoking, dyslipidemia, family history of early onset CVD in a first-degree relative (defined as younger than 55 in males or younger than 65 in females (80)), known previous cardiovascular disease (defined as past myocardial infarction, coronary revascularization, stroke, or coronary artery atherosclerosis with \>= 50% stenosis demonstrated on coronary angiography or CCTA);
• Participants with past cardiovascular disease must be in a stable clinical condition as judged by the study clinicians;
• Past cardiovascular events are defined as having occurred at least 3 months before screening;
• Evidence of detectable plasmatic sgp120 levels at any point in the past year, using the assay described priorly and performed at CRCHUM in Dr Andrés Finzi's laboratory.