Tesamorelin plus exercise to improve physical function in older adults with HIV
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
This trial will test whether adding the drug tesamorelin to a structured exercise program helps improve strength and physical performance in adults aged 50–80 living with HIV who have abdominal obesity and early frailty.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT06554717 on ClinicalTrials.gov |
What this trial studies
This phase 2 randomized study will enroll adults aged 50–80 with HIV who have been on suppressive antiretroviral therapy for at least one year, meet waist circumference thresholds for abdominal obesity, report a sedentary lifestyle, and meet at least one Fried frailty criterion. Participants will receive either tesamorelin or placebo while participating in a structured exercise program over a 24-week intervention period, with regular measures of muscle mass, strength, and physical performance. The study is conducted at Massachusetts General Hospital and the University of Colorado Anschutz Medical Campus and includes site visits for assessments. Outcomes will compare changes in physical function and muscle health between the tesamorelin and placebo groups.
Who should consider this trial
Good fit: Adults aged 50–80 with HIV on suppressive ART (HIV-1 RNA <200 copies/mL and CD4 >200/µL), who are sedentary, have abdominal obesity by waist circumference, and meet at least one Fried frailty criterion are the intended participants.
Not a fit: People with uncontrolled HIV, recent regular resistance training, no abdominal obesity, or significant unstable medical conditions are unlikely to gain benefit from this intervention.
Why it matters
Potential benefit: If successful, adding tesamorelin to exercise could increase muscle strength and physical performance and help older adults with HIV maintain independence.
How similar studies have performed: Tesamorelin is FDA-approved to reduce abdominal fat in people with HIV and has increased muscle mass in prior studies, but its effects on physical performance and muscle strength have not yet been shown.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aurora, Colorado and 1 other locations
- University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay T. Fourman, MD — Massachusetts General Hospital
- Study coordinator: Lindsay T. Fourman, MD
- Email: lfourman@mgb.org
- Phone: 617-643-4590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.