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

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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