100 Participants Needed

Tesamorelin + Exercise for HIV

(TRIUMPH Trial)

Recruiting at 1 trial location
KM
LT
Overseen ByLindsay T. Fourman, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Tesamorelin has been generally well tolerated in clinical trials for reducing excess abdominal fat in HIV patients, with some serious side effects occurring but not commonly. It has been used safely for up to 52 weeks in studies, although stopping the treatment can lead to the return of fat.12346

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

LT

Lindsay T. Fourman, MD

Principal Investigator

Massachusetts General Hospital

KM

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

Waist circumference ≥102 cm in men and ≥88 cm in women
I experience weakness, slow walking, tiredness, less physical activity, or unintended weight loss.
Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat <3 days/week with no regular resistance exercise in the past 3 months
See 5 more

Exclusion Criteria

I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.
Known hypersensitivity to tesamorelin or mannitol
Insulin-like growth factor 1 (IGF-1) z-score >2.0
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive tesamorelin or placebo and engage in a home-based exercise intervention supervised by an exercise coach

24 weeks

Extension

Participants are monitored off study drug and supervised exercise, encouraged to continue exercising independently

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Tesamorelin
Trial Overview The trial is testing the effects of tesamorelin, a drug approved for reducing belly fat in people with HIV, on improving physical function when added to an exercise regimen. Participants will either receive tesamorelin or a placebo while following a supervised home-based exercise program.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Tesamorelin Plus ExerciseActive Control2 Interventions
Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention
Group II: Placebo Plus ExercisePlacebo Group2 Interventions
Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials
9
Recruited
1,700+

University of Colorado, Denver

Collaborator

Trials
1,842
Recruited
3,028,000+

Findings from Research

Tesamorelin is effective in reducing visceral adipose tissue (VAT) in patients with HIV-associated lipodystrophy, as shown in two 26-week clinical trials, with benefits maintained for up to 52 weeks in those who continued treatment.
The treatment is generally well tolerated, with serious side effects occurring in less than 4% of patients, primarily involving injection-site reactions and common growth hormone-related issues, indicating a favorable safety profile.
Spotlight on tesamorelin in HIV-associated lipodystrophy.Dhillon, S.[2017]
Tesamorelin is effective in reducing visceral adipose tissue (VAT) in patients with HIV-associated lipodystrophy, as demonstrated in two 26-week clinical trials, with benefits maintained for up to 52 weeks in those who continued treatment.
The treatment is generally well tolerated, with serious side effects occurring in less than 4% of patients, primarily involving injection-site reactions and common growth hormone-related issues, suggesting a favorable safety profile.
Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy.Dhillon, S.[2021]
Tesamorelin, a growth hormone-releasing factor analogue, was approved by the FDA in November 2010 specifically for reducing excess abdominal fat in HIV-infected patients with lipodystrophy.
This approval highlights tesamorelin's efficacy in addressing a significant health issue related to body fat distribution in individuals with HIV, providing a targeted treatment option for this condition.
Tesamorelin.Grunfeld, C., Dritselis, A., Kirkpatrick, P.[2021]

References

Spotlight on tesamorelin in HIV-associated lipodystrophy. [2017]
Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy. [2021]
Tesamorelin. [2021]
Long-term safety and effects of tesamorelin, a growth hormone-releasing factor analogue, in HIV patients with abdominal fat accumulation. [2017]
Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial. [2023]
Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. [2022]
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