Reducing Systemic Inflammation in People on Antiretroviral Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
Known allergy to study drug;
Concomitant treatment with strong cytochrome P450 (CYP3A) inducers, including but not limited to: carbamazepine, phenytoin (anticonvulsants), mitotane (antineoplastic), enzalutamide (androgen receptor inhibitor), rifampicin (antimycobacterial) and St John's wort (Hypericum perforatum, herbal supplement);
Planning to become pregnant, pregnant, or breastfeeding (as requested per product monography (55)). Females of childbearing potential must have a negative pregnancy test at baseline visit, and follow contraception requirements throughout the treatment;
Contraindication for CT scan use (estimated glomerular filtration rate [eGFR] less than 40ml/min using the Modification of Diet in Renal Diseases [MDRD] formula or iodine allergy);
Trial design
Treatments tested in this trial
- Fostemsavir
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Clinique du Quartier Latin
Collaborator
BC Women's Hospital & Health Centre
Collaborator
Source ClinicalTrials.gov