Tesamorelin + Exercise for HIV
(TRIUMPH Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using tesamorelin or other growth hormone-based therapy, or have recently changed your glucose-lowering medication, you may not be eligible to participate.
What data supports the effectiveness of the drug Tesamorelin for reducing abdominal fat in HIV patients?
Research shows that Tesamorelin is effective in reducing excess abdominal fat in HIV patients with lipodystrophy (abnormal fat distribution). Clinical trials demonstrated that it significantly decreases visceral adipose tissue (deep belly fat) and improves body composition measures like waist circumference.12345
Is tesamorelin safe for humans?
How is the drug tesamorelin unique for treating HIV-associated lipodystrophy?
Tesamorelin is unique because it is the first and only drug specifically approved to reduce excess abdominal fat in patients with HIV-associated lipodystrophy. It works by stimulating the body's natural growth hormone production, which helps decrease visceral fat (fat around the organs) without significantly affecting subcutaneous fat (fat under the skin).12346
What is the purpose of this trial?
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.
Research Team
Lindsay T. Fourman, MD
Principal Investigator
Massachusetts General Hospital
Kristine Erlandson, MD, MS
Principal Investigator
University of Colorado, Denver
Eligibility Criteria
Adults with HIV who are experiencing physical function impairments and signs of aging such as frailty or abdominal obesity may join this trial. The study aims to see if tesamorelin helps improve their muscle health and physical performance when combined with exercise.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive tesamorelin or placebo and engage in a home-based exercise intervention supervised by an exercise coach
Extension
Participants are monitored off study drug and supervised exercise, encouraged to continue exercising independently
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Tesamorelin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
University of Colorado - Anschutz Medical Campus
Collaborator
University of Colorado, Denver
Collaborator