Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
NCT Number: NCT06554717
Acronym: TRIUMPH
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: HIV-1-infection|Frailty|Impaired Physical Function|Abdominal Obesity|Aging
Interventions: DRUG: Tesamorelin|DRUG: Placebo|BEHAVIORAL: Exercise
Sponsor: Massachusetts General Hospital
Collaborators: University of Colorado - Anschutz Medical Campus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2025-03-01
Completion Date: 2028-09-01
Locations: University of Colorado - Anschutz Medical Campus, Aurora, Colorado, 80045, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Summary:
People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term.

The goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated.

During a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently.

The investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.

Primary Outcome Measures: Change in Repeated Chair Stand Time, Time to complete 10 repeated chair stands, Baseline to Week 24
Secondary Outcome Measures: Change in Standard and Modified Short Physical Performance Battery (SPPB), Objective assessment of physical function that includes measures of balance, gait, and strength, Baseline to Week 24|Change in 1-Repetition Maximum Leg Press, Maximal weight that can be lifted by lower extremities once using correct form through full range of motion, Baseline to Week 24|Change in 400-Meter Walk Time, Time to walk 400 meters at the fastest pace possible, Baseline to Week 24|Change in Appendicular Lean Tissue Mass, Dual-energy x-ray absorptiometry (DXA) lean tissue mass in all four extremities, Baseline to Week 24|Change in Cross-Sectional Area of Trunk and Thigh Muscles, Computed tomography (CT) cross-sectional area of trunk and thigh muscles, Baseline to Week 24|Change in Frailty Phenotype, Fried Frailty Phenotype score, scored from 0 to 5 with higher indicating worse, Baseline to Week 24|Change in Quality of Life, 36-Item Short Form Health Survey (SF-36), scored from 0 to 100 with higher indicating better, Baseline to Week 24|Change in Exercise Self-Efficacy, Exercise Self-Efficacy Scale, scored from 0 to 100 with higher indicating better, Baseline to Week 24|Change in Exercise Adherence, FitBit (step count heart rate time), exercise log (movement type, repetitions, load, rate of perceived exertion), Baseline to Week 24|Change in Tissue Density of Trunk and Thigh Muscles, Computed tomography (CT) attenuation of trunk and thigh muscles, Baseline to Week 24|Change in Visceral Adipose Tissue Cross-Sectional Area, Computed tomography (CT) cross-sectional area at L4, Baseline to Week 24