TRIUMPH Trial Protocol to Assess Tesamorelin + Exercise for Physical Function in Frail Older Adults with HIV
Background
Older adults living with HIV frequently experience frailty, characterized by impaired physical function, muscle loss, and increased abdominal adiposity. Current standard-of-care interventions, primarily exercise, often fall short in fully reversing these debilitating conditions. Tesamorelin, a growth hormone-releasing hormone analogue, has shown promise in reducing visceral adipose tissue and improving body composition in HIV-associated lipodystrophy. This trial addresses the gap by investigating whether combining tesamorelin with exercise can synergistically enhance physical function and muscle quality in this vulnerable population, targeting the underlying metabolic dysfunction and sarcopenia associated with HIV and aging.
Study Design
The Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH) study is a two-site, double-blind, randomized controlled trial. It will enroll 100 sedentary older adults (aged 50-80 years) living with HIV who are frail or at risk for frailty and have excess abdominal adiposity. Participants will be randomized to receive either tesamorelin or placebo as an adjunct to a home-based, semi-supervised exercise program for 24 weeks. This will be followed by a 24-week extension phase of independent exercise. Primary endpoints include changes in physical function, while secondary endpoints encompass muscle content and quality, quality of life, and exercise adherence, measured at Weeks 24 and 48. Biological endpoints like muscle fat and mitochondrial function will be assessed at Week 24 using MRI and biopsy analyses.
Results
As a clinical trial protocol, this study outlines the intended findings rather than presenting results. The TRIUMPH trial aims to determine both short-term (Week 24) and sustained (Week 48) effects of tesamorelin combined with exercise on critical clinical endpoints. The primary objective is to quantify improvements in physical function, expecting a statistically significant enhancement in the tesamorelin group compared to placebo. Secondary objectives include measuring changes in muscle content and quality, anticipating an increase in lean mass and strength. The study also seeks to assess improvements in overall quality of life and exercise adherence. Furthermore, at Week 24, the trial will elucidate effects on biological endpoints, specifically changes in muscle fat infiltration and mitochondrial function, which are hypothesized to improve with tesamorelin treatment. > The core hypothesis is that tesamorelin will significantly augment the benefits of exercise, leading to superior outcomes in physical function and body composition in frail older adults with HIV.
Key Findings
- Assess short-term (Week 24) and sustained (Week 48) effects of tesamorelin + exercise on physical function.
- Quantify improvements in muscle content and quality at Weeks 24 and 48.
- Evaluate changes in quality of life and exercise adherence.
- Elucidate effects on muscle fat and mitochondrial function at Week 24.
Why It Matters
This trial could significantly impact the management of frailty and sarcopenia in older adults with HIV. If successful, it would provide a novel, evidence-based adjunctive therapy to exercise, potentially improving patient independence and quality of life. For peptide users and clinicians, this could establish a new protocol for combining tesamorelin with structured exercise to combat age- and disease-related physical decline. The findings will inform future interventions, potentially leading to a more comprehensive approach than exercise alone. While results are pending, a positive outcome would move tesamorelin closer to being a standard component in anti-frailty strategies for this specific population, offering a tangible pathway to better functional outcomes.
tesamorelin
hiv
frailty
physical-function
abdominal-obesity
exercise