HIV-1-infectionPhase 2TRIUMPHNCT06554717
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
A Phase 2 study testing Tesamorelin and Exercise in people with HIV-1-infection and Frailty, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- HIV-1-infection, Frailty, Impaired Physical Function
- What is being tested?
- Tesamorelin and Exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2025to 1 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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
- ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)
- 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
- 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
- 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
- Provider approval to participate
Who cannot join
- Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- Insulin-like growth factor 1 (IGF-1) z-score >2.0
- HbA1c >8%
- Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
- Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
- Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
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- 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
- Known hypersensitivity to tesamorelin or mannitol
- Acute or chronic illness judged by the investigator to represent a contraindication to study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
Kristine M. Erlandson, MD, 3037244941, kristine.erlandson@cuanschutz.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lindsay T Fourman, MD, 6176434590, LFourman@mgb.org
Julia Johnson, 617-724-5545, jjohnson110@mgh.harvard.edu
About this study
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.
Read more
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.
- Conditions
- HIV-1-infection, Frailty, Impaired Physical Function, Abdominal Obesity, Aging
- Being tested
- Tesamorelin, Placebo, Exercise
- Medical subject headings
- Frailty, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TesamorelinDrug
Also called Egrifta, TH9507, growth hormone-releasing hormone analogue
Tesamorelin WR 1.28 mg given subcutaneously daily
PlaceboDrug
Identical placebo injection given subcutaneously daily
ExerciseBehavioural
Home-based semi-supervised exercise program
| Study group | Role | What they receive |
|---|---|---|
| Tesamorelin Plus Exercise | Active comparator | Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention Receives: Drug: Tesamorelin; Behavioral: Exercise |
| Placebo Plus Exercise | Placebo comparator | Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention Receives: Drug: Placebo; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Repeated Chair Stand Time
Time to complete 10 repeated chair stands
Measured: Baseline to Week 24
Secondary outcomes (11)
Change in Standard and Modified Short Physical Performance Battery (SPPB)
Objective assessment of physical function that includes measures of balance, gait, and strength
Measured: Baseline to Week 24
Change in 1-Repetition Maximum Leg Press
Maximal weight that can be lifted by lower extremities once using correct form through full range of motion
Measured: Baseline to Week 24
Change in 400-Meter Walk Time
Time to walk 400 meters at the fastest pace possible
Measured: Baseline to Week 24
Change in Appendicular Lean Tissue Mass
Dual-energy x-ray absorptiometry (DXA) lean tissue mass in all four extremities
Measured: Baseline to Week 24
Change in Cross-Sectional Area of Trunk and Thigh Muscles
Computed tomography (CT) cross-sectional area of trunk and thigh muscles
Measured: Baseline to Week 24
Change in Frailty Phenotype
Fried Frailty Phenotype score, scored from 0 to 5 with higher indicating worse
Measured: Baseline to Week 24
Change in Quality of Life
36-Item Short Form Health Survey (SF-36), scored from 0 to 100 with higher indicating better
Measured: Baseline to Week 24
Change in Exercise Self-Efficacy
Exercise Self-Efficacy Scale, scored from 0 to 100 with higher indicating better
Measured: Baseline to Week 24
Change in Exercise Adherence
FitBit (step count heart rate time), exercise log (movement type, repetitions, load, rate of perceived exertion)
Measured: Baseline to Week 24
Change in Tissue Density of Trunk and Thigh Muscles
Computed tomography (CT) attenuation of trunk and thigh muscles
Measured: Baseline to Week 24
Change in Visceral Adipose Tissue Cross-Sectional Area
Computed tomography (CT) cross-sectional area at L4
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start10 Jul 2025
- Primary completion16 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Lindsay Fourman, MD, Massachusetts General Hospital
- Investigators
- Lindsay T. Fourman, MD, Principal investigator, Massachusetts General HospitalKristine M. Erlandson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06554717
- Sponsor's protocol ID
- 2024P001703
- Acronym
- TRIUMPH
- Status last verified
- May 2026
- First submitted
- 12 Aug 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Erlandson KM, Gustafson L, Johnson JE, Kulik GL, Khuu V, Chahal N, Walpert AR, Galdamez ME, Zorgno I, Foldyna B, Jarraya M, Reusch JE, Lee H, Grinspoon SK, Jankowski CM, Fourman LT. Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol. BMJ Open. 2026 Jul 8;16(7):e120740. doi: 10.1136/bmjopen-2026-120740.
PubMed 42419889
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
- ClinicalTrials.gov ID
- NCT06554717
- Acronym / sponsor ID
- TRIUMPH / 2024P001703
- Conditions
- HIV-1-infection, Frailty, Impaired Physical Function, Abdominal Obesity, Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 16 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tesamorelin Plus Exercise | Active comparator | Drug: Tesamorelin, Behavioral: ExerciseTesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention |
| Placebo Plus Exercise | Placebo comparator | Drug: Placebo, Behavioral: ExerciseIdentical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 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
- ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)
- 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
Key exclusion criteria (10 listed)
- Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- Insulin-like growth factor 1 (IGF-1) z-score >2.0
- HbA1c >8%
- Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
- Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TesamorelinAlso: Egrifta, TH9507, growth hormone-releasing hormone analogueTesamorelin WR 1.28 mg given subcutaneously daily | Drug | Tesamorelin Plus Exercise |
| PlaceboIdentical placebo injection given subcutaneously daily | Drug | Placebo Plus Exercise |
| ExerciseHome-based semi-supervised exercise program | Behavioural | Placebo Plus Exercise, Tesamorelin Plus Exercise |
Primary outcome
Change in Repeated Chair Stand Time
Time frame: Baseline to Week 24
Time to complete 10 repeated chair stands
11 secondary outcomes
Change in Standard and Modified Short Physical Performance Battery (SPPB)
Time frame: Baseline to Week 24
Change in 1-Repetition Maximum Leg Press
Time frame: Baseline to Week 24
Change in 400-Meter Walk Time
Time frame: Baseline to Week 24
Change in Appendicular Lean Tissue Mass
Time frame: Baseline to Week 24
Change in Cross-Sectional Area of Trunk and Thigh Muscles
Time frame: Baseline to Week 24
Change in Frailty Phenotype
Time frame: Baseline to Week 24
Change in Quality of Life
Time frame: Baseline to Week 24
Change in Exercise Self-Efficacy
Time frame: Baseline to Week 24
Change in Exercise Adherence
Time frame: Baseline to Week 24
Change in Tissue Density of Trunk and Thigh Muscles
Time frame: Baseline to Week 24
Change in Visceral Adipose Tissue Cross-Sectional Area
Time frame: Baseline to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 42419889Erlandson KM, Gustafson L, Johnson JE, Kulik GL, Khuu V, Chahal N, Walpert AR, Galdamez ME, Zorgno I, Foldyna B, Jarraya M, Reusch JE, Lee H, Grinspoon SK, Jankowski CM, Fourman LT. Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol. BMJ Open. 2026 Jul 8;16(7):e120740. doi: 10.1136/bmjopen-2026-120740.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay T. Fourman, MD principal investigator
Massachusetts General Hospital
Kristine M. Erlandson, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tesamorelin and Exercise in people with HIV-1-infection and Frailty, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay T. Fourman, MD (617-643-4590, lfourman@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Repeated Chair Stand Time (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06554717, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.