Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol.

BACKGROUND

The Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH) study is a randomised controlled trial with the overall goal of examining the combined effect of exercise and the growth hormone-releasing hormone analogue tesamorelin on physical function.

METHODS

TRIUMPH is a two-site, double-blind, randomised trial of 100 sedentary older adults (aged 50-80 years) living with HIV who are frail or at risk for frailty and have excess abdominal adiposity. Enrolled participants will be randomised to receive tesamorelin or placebo as an adjunct to a home-based semisupervised exercise programme for 24 weeks, followed by a 24-week extension phase of independent exercise. We will determine short-term and sustained effects of tesamorelin plus exercise on clinical endpoints, including physical function, muscle content and quality, quality of life, and exercise adherence at Weeks 24 and 48. We also will elucidate effects of tesamorelin plus exercise on biological endpoints, including muscle fat and mitochondrial function at Week 24.

ETHICS AND DISSEMINATION: Ethical approval for the TRIUMPH study was obtained from the Institutional Review Boards at participating sites. All participants provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and scientific conferences and may inform future interventions to improve physical function among older adults living with HIV.

TRIAL REGISTRATION NUMBER: NCT06554717.