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Reducing Systemic Inflammation in People on Antiretroviral Therapy

Study acronym: RESTART
StatusRecruiting
PhasePhase 2
Started2025-09-30
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-10→confirmed 2025-09-30
Study sitesdetails revised at 1 of 1 site
2025-06-12
Original filing
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.
Trial Details
NCT Number NCT07030920
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre, Clinique du Quartier Latin, BC Women's Hospital & Health Centre
Conditions Human Immunodeficiency Virus (HIV), Cardiovascular Risk Factor
Enrollment 150 participants
Start Date 2025-09-30
Primary Completion 2028-10 (estimated)
Study Completion 2029-01 (estimated)
Updated on ClinicalTrials.gov 2025-11-19