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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 belowSelect...
I am between 50 and 80 years old.
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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.
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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
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 moreTrial 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
7 Previous Clinical Trials
1,491 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,026 Previous Clinical Trials
13,413,699 Total Patients Enrolled
2 Trials studying Frailty
911 Patients Enrolled for Frailty
Lindsay T. Fourman, MDPrincipal InvestigatorMassachusetts General Hospital
Kristine M. Erlandson, MDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus