drugset / Trial / NCT07030920
Reducing Systemic Inflammation in People on Antiretroviral Therapy
Phase 2
Recruiting
150 enrolled
University of Montreal Hospital Centre (CHUM)
BC Women's Hospital & Health Centre · collabClinique du Quartier Latin · collabMcGill University Health Centre/Research Institute of the McGill University Health Centre · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2025-09-30
- Primary completion
- 2028-10
- Completion
- 2029-01
Publications
- Background Benlarbi M, Richard J, Bourassa C, Tolbert WD, Chartrand-Lefebvre C, Gendron-Lepage G, Sylla M, El-Far M, Messier-Peet M, Guertin C, Turcotte I, Fromentin R, Verly MM, Prevost J, Clark A, Mothes W, Kaufmann DE, Maldarelli F, Chomont N, Begin P, Tremblay C, Baril JG, Trottier B, Trottier S, Duerr R, Pazgier M, Durand M, Finzi A. Plasma Human Immunodeficiency Virus 1 Soluble Glycoprotein 120 Association With Correlates of Immune Dysfunction and Inflammation in Antiretroviral Therapy-Treated Individuals With Undetectable Viremia. J Infect Dis. 2024 Mar 14;229(3):763-774. doi: 10.1093/infdis/jiad503.
- Background Richard J, Prevost J, Bourassa C, Brassard N, Boutin M, Benlarbi M, Goyette G, Medjahed H, Gendron-Lepage G, Gaudette F, Chen HC, Tolbert WD, Smith AB 3rd, Pazgier M, Dube M, Clark A, Mothes W, Kaufmann DE, Finzi A. Temsavir blocks the immunomodulatory activities of HIV-1 soluble gp120. Cell Chem Biol. 2023 May 18;30(5):540-552.e6. doi: 10.1016/j.chembiol.2023.03.003. Epub 2023 Mar 22.
- Background Durand M, Sheehy O, Baril JG, Lelorier J, Tremblay CL. Association between HIV infection, antiretroviral therapy, and risk of acute myocardial infarction: a cohort and nested case-control study using Quebec's public health insurance database. J Acquir Immune Defic Syndr. 2011 Jul 1;57(3):245-53. doi: 10.1097/QAI.0b013e31821d33a5.
- Background Durand M, Chartrand-Lefebvre C, Baril JG, Trottier S, Trottier B, Harris M, Walmsley S, Conway B, Wong A, Routy JP, Kovacs C, MacPherson PA, Monteith KM, Mansour S, Thanassoulis G, Abrahamowicz M, Zhu Z, Tsoukas C, Ancuta P, Bernard N, Tremblay CL; investigators of the Canadian HIV and Aging Cohort Study. The Canadian HIV and aging cohort study - determinants of increased risk of cardio-vascular diseases in HIV-infected individuals: rationale and study protocol. BMC Infect Dis. 2017 Sep 11;17(1):611. doi: 10.1186/s12879-017-2692-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fostemsavir | Other / unclassified | 600 mg | Oral |