Tesamorelin + Exercise for HIV

(TRIUMPH Trial)

Recruiting at 1 trial location

Overseen By Lindsay T. Fourman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Growth hormones, Corticosteroids

Disqualifiers: Malignancy, Coronary artery disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tesamorelin, combined with exercise, can improve physical function and muscle health in adults with HIV. Tesamorelin currently manages abdominal fat in people with HIV, and researchers aim to determine if it also enhances muscle strength and performance. Participants will be divided into two groups: one receiving tesamorelin and the other a placebo (a substance with no active drug), both alongside a guided home exercise program. The trial seeks individuals aged 50-80 with HIV on stable treatment, who lead a sedentary lifestyle and meet specific health criteria, such as a larger waistline and signs of frailty. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tesamorelin is generally safe for people with HIV. In studies, about 3.6% of patients experienced allergic reactions, indicating that while some had mild allergies, most did not encounter serious side effects.

The FDA has already approved tesamorelin to help reduce belly fat in people with HIV, suggesting it is considered safe for this group. Previous research also shows it effectively reduces belly fat without causing major issues for most patients.

Overall, evidence suggests tesamorelin is safe for many people, though some might have mild reactions. As with any treatment, discussing concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for HIV?

Unlike the standard treatments for HIV-associated lipodystrophy, which include lifestyle changes and certain medications, Tesamorelin is unique because it specifically targets and reduces excess abdominal fat by stimulating the release of growth hormone. This mechanism not only addresses the physical aspect of lipodystrophy but may also improve metabolic health in patients. Researchers are excited about Tesamorelin because it offers a novel approach that combines medication with exercise to potentially enhance overall effectiveness, setting it apart from current options that often focus solely on medication or lifestyle changes.

What evidence suggests that this trial's treatments could be effective for improving physical function in people with HIV?

Research has shown that tesamorelin, a medication similar to a growth hormone, reduces belly fat in people with HIV. The FDA has approved it for this purpose, confirming its effectiveness for body fat changes linked to HIV. While tesamorelin increases muscle mass and improves muscle health, its exact impact on physical performance and strength in people with HIV remains under study. In this trial, some participants will receive tesamorelin combined with exercise, while others will receive a placebo with exercise. Combining tesamorelin with exercise might enhance physical function and muscle health more than exercise alone, but further research is needed to confirm this. ^{6 7 8 9 10}

Who Is on the Research Team?

Lindsay T. Fourman, MD

Principal Investigator

Massachusetts General Hospital

Kristine Erlandson, MD, MS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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

I experience weakness, slow walking, tiredness, less physical activity, or unintended weight loss.

Waist circumference ≥102 cm in men and ≥88 cm in women

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

Exclusion Criteria

Known hypersensitivity to tesamorelin or mannitol

I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.

I haven't changed my steroid or testosterone treatment in the last 3 months.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Tesamorelin Plus Exercise Active Control 2 Interventions

Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention

Group II: Placebo Plus Exercise Placebo Group 2 Interventions

Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin. Grunfeld, C., Dritselis, A., Kirkpatrick, P.[2021]

Tesamorelin has been shown to significantly reduce waist circumference and visceral adipose tissue in patients with HIV-associated lipodystrophy after 26 weeks of treatment, improving body image as well.

The treatment was found to maintain these improvements without negatively affecting blood glucose and lipid levels, indicating its safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy. Spooner, LM., Olin, JL.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tesamorelin: a review of its use in the management of HIV-associated lipodystrophy. Dhillon, S.[2021]

In a post hoc analysis of a phase III clinical trial involving participants treated with tesamorelin for 26 weeks, the drug effectively reduced visceral adipose tissue (VAT) and waist circumference in individuals with and without dorsocervical fat.

The results indicate that tesamorelin is equally effective in reducing excess VAT regardless of the presence of dorsocervical fat, suggesting it can be a suitable treatment option for all patients with HIV-related fat accumulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tesamorelin in people with HIV with and without dorsocervical fat: Post hoc analysis of phase III double-blind placebo-controlled trial. Rahman, F., McLaughlin, T., Mesquita, P., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on tesamorelin in HIV-associated lipodystrophy. Dhillon, S.[2017]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK539124/

Executive Summary - Clinical Review Report: Tesamorelin ...

Human immunodeficiency virus (HIV)–associated lipodystrophy ... There were limited data to evaluate the effects of tesamorelin on important safety outcomes ...

2.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2010/022505Orig1s000SumR.pdf

SUMMARY REVIEW - accessdata.fda.gov

This new drug application proposes for the use of Egrifta (tesamorelin acetate), a synthetic growth hormone releasing factor (GHRF) analog, ...

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sciencedirect.com

sciencedirect.com/topics/medicine-and-dentistry/tesamorelin

Tesamorelin - an overview

Tesamorelin is effective in counteracting body fat changes caused by HIV-related lipodystrophy [101,107,119], and is safe even when the treatment period is ...

4.

infectiousdiseaseadvisor.com

infectiousdiseaseadvisor.com/news/egrifta-wr-now-available-for-hiv-related-lipodystrophy/

Egrifta WR Now Available for HIV-Related Lipodystrophy

Egrifta WR™, a new concentrated formulation (F8) of tesamorelin, is now available for the reduction of excess abdominal fat in HIV-infected ...

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molinahealthcare.com

molinahealthcare.com/providers/wa/medicaid/resource/PDF/egrifta-tesamorelin-mcp131.pdf

Egrifta Tesamorelin Molina Clinical Policy 131

⌘ While Egrifta™ (tesamorelin) is FDA-approved for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy, an improvement in net ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20554713/

Effects of tesamorelin (TH9507), a growth hormone ...

Objective: Our objective was to perform a pooled analysis of two phase-3 studies of tesamorelin in ART-treated HIV patients with excess abdominal fat. Design ...

7.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2019/022505Orig1s010lbl.pdf

EGRIFTA® (tesamorelin for injection), for subcutaneous use

Hypersensitivity reactions occurred in 3.6% of patients with HIV-associated lipodystrophy treated with EGRIFTA® in the Phase 3 clinical trials.

8.

ema.europa.eu

ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-egrifta_en.pdf

Withdrawal Assessment report | EMA

The intended use for tesamorelin in this application is the treatment of excess abdominal fat in adult HIV-infected patients with lipodystrophy; ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00608023

TH9507 Extension Study in Patients With HIV-Associated ...

Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3218714/

Growth hormone and tesamorelin in the management of HIV ...

Randomized controlled trials have shown that administration of tesamorelin is safe and effective in reducing central fat accumulation among HIV-infected ...