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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Aug 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tesamorelin to see if it can help improve physical function and muscle health in adults with HIV when combined with exercise. People living with HIV often face challenges like weakness and fatigue, which can make it harder for them to stay active and healthy as they age. The goal of the study is to determine if tesamorelin, which is already approved to treat excess abdominal fat in HIV patients, can also boost muscle strength and improve how well participants can function physically.

To be eligible for the trial, participants must be men or women aged 50 to 80 who have been receiving treatment for HIV for at least a year. They should have a sedentary lifestyle and meet certain health criteria, such as having a specific waist size and showing signs of frailty. During the trial, participants will take either tesamorelin or a placebo (a substance that looks like the drug but has no active ingredients) for 24 weeks while also participating in a supervised home exercise program. After that, they'll be encouraged to continue exercising on their own for another 24 weeks without the study medication. This research could lead to new ways to help people with HIV feel better and maintain their health as they age.

Gender

ALL

Eligibility 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