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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

Awards & highlights

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

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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.

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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:

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I do not have active heart issues like unstable angina or serious arrhythmias.

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I have a condition that affects my growth hormone levels.

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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

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado - Anschutz Medical CampusUNKNOWN

3 Previous Clinical Trials

538 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,993 Previous Clinical Trials

13,230,621 Total Patients Enrolled

Lindsay T. Fourman, MDPrincipal InvestigatorMassachusetts General Hospital

~67 spots leftby Mar 2028

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