Phase 2 Study of Adding Fostemsavir to Antiretroviral Therapy to Reduce Inflammation and Cardiovascular Risk in People with Well-Controlled HIV

What this Trial Is About

Researchers are evaluating whether adding fostemsavir to the current antiretroviral therapy can reduce the risk of cardiovascular disease in people living with HIV who have well-controlled infection. This Phase IIb randomized, open-label clinical trial focuses on individuals with undetectable viral loads but detectable soluble HIV gp120, which is linked to chronic inflammation and increased health risks such as cardiovascular disease, cognitive decline, and frailty. Participants will be randomly assigned to one of two groups one group will take fostemsavir Rukobia 600 mg extended-release tablet once daily along with their existing antiretroviral regimen for 24 months, while the other group will continue their standard care with current antiretroviral therapy and other prescribed medications. The study uses a 11 randomization process stratified by sex and statin use, with follow-up visits scheduled at months 1, 6, 12, 18, 24, and 27. Throughout the study, participants will undergo assessments including coronary computed tomography angiography CCTA, grip strength tests, and cognitive testing B-CAM at baseline and at month 24. Blood samples will be collected at each visit for biomarker analysis. Researchers will monitor changes in uncalcified plaque volume, cardiovascular events, cognitive ability, and grip strength, as well as safety outcomes such as adverse events and treatment discontinuation. The total study duration for participants is about 27 months.

Reducing Systemic Inflammation in People on Antiretroviral Therapy