← Back to Search

Tesamorelin + Exercise for HIV (TRIUMPH Trial)

Phase 2
Waitlist Available
Led By Lindsay T. Fourman, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women, 50-80 years old
Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA <200 copies/mL and CD4+ T cell count >200/µL
Must not have
Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia
History of hypopituitarism, head irradiation, or other conditions known to affect the GH/IGF-1 axis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24

Summary

This trial aims to see if a drug called tesamorelin can improve physical function and muscle health in adults with HIV when combined with exercise. People with HIV often experience physical impairments earlier than others

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from tesamorelin include joint pain, skin reactions at the injection site, swelling in legs and arms, muscle pain, numbness and tingling sensations. Exercise might cause typical discomfort like sore muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 80 years old.
Select...
I have HIV, on treatment for over a year, with low virus levels and enough CD4 cells.
Select...
I experience weakness, slow walking, tiredness, less physical activity, or unintended weight loss.
Select...
I am a woman who has not had a period for at least 12 months or have had both ovaries removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have active heart issues like unstable angina or serious arrhythmias.
Select...
I have a condition that affects my growth hormone levels.
Select...
I haven't used tesamorelin or any growth hormone therapy in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Repeated Chair Stand Time
Secondary study objectives
Change in 1-Repetition Maximum Leg Press
Change in 400-Meter Walk Time
Change in Appendicular Lean Tissue Mass
+8 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tesamorelin Plus ExerciseActive Control2 Interventions
Tesamorelin SV 1.4 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 Location

Who is running the clinical trial?

University of Colorado - Anschutz Medical CampusUNKNOWN
6 Previous Clinical Trials
1,365 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,280 Total Patients Enrolled
2 Trials studying Frailty
911 Patients Enrolled for Frailty
Lindsay T. Fourman, MDPrincipal InvestigatorMassachusetts General Hospital
~67 spots leftby Mar 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top