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

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (NCT06554717) is a Phase 2 interventional studying HIV-1-infection and Frailty, sponsored by Massachusetts General Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HIV-1-infection and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HIV-1-infection subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Waist circumference ≥102 cm in men and ≥88 cm in women 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 Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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. Waist circumference ≥102 cm in men and ≥88 cm in women 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

Treatments Being Tested

DRUG

Tesamorelin

Tesamorelin WR 1.28 mg given subcutaneously daily

DRUG

Placebo

Identical placebo injection given subcutaneously daily

BEHAVIORAL

Exercise

Home-based semi-supervised exercise program

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06554717), the sponsor (Massachusetts General Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06554717 clinical trial studying?

Who can participate in NCT06554717?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06554717?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06554717. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06554717. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.