NCT06554717Toboroz2. fázis
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 19.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2024. aug. 12.
- Kezdés
- 2025. júl. 10.
- Elsődleges befejezés
- 2028. jún. 16.
- Fő szponzor
- Massachusetts General Hospital
- Betegségek
- HIV-fertőzés, Elhízás
- NCT-szám
- NCT06554717
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 100
- 2025. júl. 10. és az elsődleges befejezés (2028. jún. 16.) között
- 2 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
- Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
Más betegség
- Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 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
Laborértékek
- HbA1c >8%
- Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
Egyéb
- Insulin-like growth factor 1 (IGF-1) z-score >2.0
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 50 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (2)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Egyesült Államok | Toboroz |
| Massachusetts General Hospital | Boston | Egyesült Államok | Toboroz |
Kapcsolódó publikációk
- Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol.BMJ Open · 2026 · PMID 42419889
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.