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Trial · Interventional

RecruitingPhase 2Registry data

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

Short name TRIUMPH

NCTNCT06554717 (opens ClinicalTrials.gov in a new tab)Other id2024P001703
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
100 participants (estimated)
Sponsor
Massachusetts General Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
10 Jul 2025
Primary completion
16 Jun 2028 (estimated)
Completion
1 Dec 2028 (estimated)
First posted
15 Aug 2024
Last update posted
19 May 2026
Conditions
HIV-1-infection · Frailty · Impaired Physical Function · Abdominal Obesity · Aging

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 2

    TRIUMPH

    NCT06554717

    10 Jul 2025 to est. 1 Dec 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

People with HIV experience earlier impairments in physical function compared to people in the general population. They also exhibit an earlier presentation and more rapid development of frailty, a multisystemic syndrome of aging characterized by reduced activity, fatigue, slowness, weakness, and weight loss. While exercise can improve physical function in people with HIV, it is less effective in doing so than in the general population and is difficult to sustain in the long-term. The goal of this clinical trial is to learn whether the medication tesamorelin will improve physical function and muscle health in adults with HIV when combined with exercise. Tesamorelin is a growth hormone-releasing hormone analogue that is FDA-approved to treat abdominal fat accumulation in people with HIV. While tesamorelin has also been shown to increase muscle mass and improve measures of muscle health, its effects on physical performance and muscle strength have not yet been evaluated. During a 24-week intervention phase, half of participants will be randomly assigned to receive tesamorelin and half of participants will be randomly assigned to receive placebo (a look-alike substance that contains no drug). All participants also will engage in a home-based exercise intervention supervised by an exercise coach. During a subsequent 24-week extension phase, individuals will be monitored off study drug and supervised exercise, and be encouraged to continue to exercise independently. The investigators will investigate effects of tesamorelin on physical function, muscle mass and quality, quality of life, and exercise adherence and self-efficacy. They also will evaluate whether effects of tesamorelin are maintained following treatment cessation. This study may identify an important strategy to improve how individuals aging with HIV function and feel with potential applications to other patient populations.

Interventions

  • TesamorelinDrug
  • PlaceboDrug
  • ExerciseBehavioral

Arms2

  • Active comparator

    Tesamorelin Plus Exercise

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

  • Placebo comparator

    Placebo Plus Exercise

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Repeated Chair Stand Time

    Time frame · Baseline to Week 24

    Registry description

    Time to complete 10 repeated chair stands

Secondary outcomes(11)

  1. Change in Standard and Modified Short Physical Performance Battery (SPPB)

    Time frame · Baseline to Week 24

    Registry description

    Objective assessment of physical function that includes measures of balance, gait, and strength

  2. Change in 1-Repetition Maximum Leg Press

    Time frame · Baseline to Week 24

    Registry description

    Maximal weight that can be lifted by lower extremities once using correct form through full range of motion

  3. Change in 400-Meter Walk Time

    Time frame · Baseline to Week 24

    Registry description

    Time to walk 400 meters at the fastest pace possible

  4. Change in Appendicular Lean Tissue Mass

    Time frame · Baseline to Week 24

    Registry description

    Dual-energy x-ray absorptiometry (DXA) lean tissue mass in all four extremities

  5. Change in Cross-Sectional Area of Trunk and Thigh Muscles

    Time frame · Baseline to Week 24

    Registry description

    Computed tomography (CT) cross-sectional area of trunk and thigh muscles

  6. Change in Frailty Phenotype

    Time frame · Baseline to Week 24

    Registry description

    Fried Frailty Phenotype score, scored from 0 to 5 with higher indicating worse

  7. Change in Quality of Life

    Time frame · Baseline to Week 24

    Registry description

    36-Item Short Form Health Survey (SF-36), scored from 0 to 100 with higher indicating better

  8. Change in Exercise Self-Efficacy

    Time frame · Baseline to Week 24

    Registry description

    Exercise Self-Efficacy Scale, scored from 0 to 100 with higher indicating better

  9. Change in Exercise Adherence

    Time frame · Baseline to Week 24

    Registry description

    FitBit (step count heart rate time), exercise log (movement type, repetitions, load, rate of perceived exertion)

  10. Change in Tissue Density of Trunk and Thigh Muscles

    Time frame · Baseline to Week 24

    Registry description

    Computed tomography (CT) attenuation of trunk and thigh muscles

  11. Change in Visceral Adipose Tissue Cross-Sectional Area

    Time frame · Baseline to Week 24

    Registry description

    Computed tomography (CT) cross-sectional area at L4

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2026

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol.

Erlandson et al. 2026BMJ opencited by 2

PMID 42419889PMC13347827DOI 10.1136/bmjopen-2026-120740PUB-42419889

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Men and women, 50-80 years old 2. 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 3 3. 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 4. ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds) 5. Excess abdominal adiposity as indicated by at least one of the following elevated anthropometric measures assessed at Screen: (1) waist circumference ≥102 cm in non-Asian males (≥90 cm in Asian males) or ≥88 cm in non-Asian females (≥80 cm in Asian females); (2) waist-to-hip ratio ≥0.9 in males or ≥0.85 in females; (3) waist-to-height ratio ≥0.5 in males and females 6. Normal mammogram within 2 years (females ≤74 years old) or prostate specific antigen \<4 ng/mL (males ≤70 years old) per U.S. Preventive Services Task Force (USPSTF) age-appropriate cancer screening guidelines 7. For females, postmenopausal defined as no menses for ≥12 months and anti-müllerian hormone (AMH) \<20 pg/mL or history of bilateral oophorectomy at least 3 months ago 8. Provider approval to participate Exclusion Criteria: 1. Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months 2. Insulin-like growth factor 1 (IGF-1) z-score \>2.0 3. HbA1c \>8% 4. Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months 5. Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months 6. Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months 7. Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia 8. History of hypopituitarism, head irradiation, or other conditions known to affect the GH/IGF-1 axis 9. Known hypersensitivity to tesamorelin or mannitol 10. Acute or chronic illness judged by the investigator to represent a contraindication to study participation

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