Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Change in Repeated Chair Stand Time
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- •Insulin-like growth factor 1 (IGF-1) z-score >2.0
- •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
研究组 & 干预措施
Tesamorelin Plus Exercise
Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention
干预措施: Tesamorelin (Drug)
Tesamorelin Plus Exercise
Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention
干预措施: Exercise (Behavioral)
Placebo Plus Exercise
Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention
干预措施: Placebo (Drug)
Placebo Plus Exercise
Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention
干预措施: Exercise (Behavioral)
结局指标
主要结局
Change in Repeated Chair Stand Time
时间窗: Baseline to Week 24
Time to complete 10 repeated chair stands
次要结局
- Change in 1-Repetition Maximum Leg Press(Baseline to Week 24)
- Change in Standard and Modified Short Physical Performance Battery (SPPB)(Baseline to Week 24)
- Change in 400-Meter Walk Time(Baseline to Week 24)
- Change in Appendicular Lean Tissue Mass(Baseline to Week 24)
- Change in Cross-Sectional Area of Trunk and Thigh Muscles(Baseline to Week 24)
- Change in Frailty Phenotype(Baseline to Week 24)
- Change in Quality of Life(Baseline to Week 24)
- Change in Tissue Density of Trunk and Thigh Muscles(Baseline to Week 24)
- Change in Visceral Adipose Tissue Cross-Sectional Area(Baseline to Week 24)
- Change in Exercise Self-Efficacy(Baseline to Week 24)
- Change in Exercise Adherence(Baseline to Week 24)
研究者
Lindsay Fourman, MD
Assistant Professor of Medicine
Massachusetts General Hospital