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
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.12345
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.678910
Who Is on the Research Team?
LT
Lindsay T. Fourman, MD
Principal Investigator
Massachusetts General Hospital
KM
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
See 5 more
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.
See 7 more
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?
Treatment 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+
Published Research Related to This Trial
Citations