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

Обзор

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.

Вмешательства

• Препарат Tesamorelin
  Tesamorelin WR 1.28 mg given subcutaneously daily
• Препарат Placebo
  Identical placebo injection given subcutaneously daily
• Поведенческое Exercise
  Home-based semi-supervised exercise program

Первичные конечные точки

• Change in Repeated Chair Stand Time [Срок оценки: Baseline to Week 24]

Вторичные конечные точки (11)

• Change in Standard and Modified Short Physical Performance Battery (SPPB) [Срок оценки: Baseline to Week 24]
• Change in 1-Repetition Maximum Leg Press [Срок оценки: Baseline to Week 24]
• Change in 400-Meter Walk Time [Срок оценки: Baseline to Week 24]
• Change in Appendicular Lean Tissue Mass [Срок оценки: Baseline to Week 24]
• Change in Cross-Sectional Area of Trunk and Thigh Muscles [Срок оценки: Baseline to Week 24]
• Change in Frailty Phenotype [Срок оценки: Baseline to Week 24]
• Change in Quality of Life [Срок оценки: Baseline to Week 24]
• Change in Exercise Self-Efficacy [Срок оценки: Baseline to Week 24]
• Change in Exercise Adherence [Срок оценки: Baseline to Week 24]
• Change in Tissue Density of Trunk and Thigh Muscles [Срок оценки: Baseline to Week 24]
• Change in Visceral Adipose Tissue Cross-Sectional Area [Срок оценки: Baseline to Week 24]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• University of Colorado - Anschutz Medical Campus — Aurora
• Massachusetts General Hospital — Boston

Публикации

• 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. PMID 42419889

Идентификаторы

NCT: NCT06554717 · 2024P001703

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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