[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06554717":3,"trial-entities:NCT06554717":150,"trial-summary:NCT06554717":158},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":50,"secondary_outcomes":55,"sex":89,"minimum_age":90,"maximum_age":91,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":97,"locations":100,"central_contacts":132,"overall_officials":139,"references":144,"see_also_links":149},"NCT06554717","2024P001703","Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV","RECRUITING","2028-12-01","2026-05","2026-05-19","2025-07-10","Massachusetts General Hospital","OTHER",true,"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.\n\nThe 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.\n\nDuring 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.\n\nThe 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.",null,[18,19,20,21,22],"HIV-1-infection","Frailty","Impaired Physical Function","Abdominal Obesity","Aging",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},100,"ESTIMATED",[32,40,45],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Tesamorelin","Tesamorelin WR 1.28 mg given subcutaneously daily",[37],"Tesamorelin Plus Exercise",[39],"Egrifta, TH9507, growth hormone-releasing hormone analogue",{"type":33,"name":41,"description":42,"armGroupLabels":43},"Placebo","Identical placebo injection given subcutaneously daily",[44],"Placebo Plus Exercise",{"type":46,"name":47,"description":48,"armGroupLabels":49},"BEHAVIORAL","Exercise","Home-based semi-supervised exercise program",[44,37],[51],{"measure":52,"description":53,"timeFrame":54},"Change in Repeated Chair Stand Time","Time to complete 10 repeated chair stands","Baseline to Week 24",[56,59,62,65,68,71,74,77,80,83,86],{"measure":57,"description":58,"timeFrame":54},"Change in Standard and Modified Short Physical Performance Battery (SPPB)","Objective assessment of physical function that includes measures of balance, gait, and strength",{"measure":60,"description":61,"timeFrame":54},"Change in 1-Repetition Maximum Leg Press","Maximal weight that can be lifted by lower extremities once using correct form through full range of motion",{"measure":63,"description":64,"timeFrame":54},"Change in 400-Meter Walk Time","Time to walk 400 meters at the fastest pace possible",{"measure":66,"description":67,"timeFrame":54},"Change in Appendicular Lean Tissue Mass","Dual-energy x-ray absorptiometry (DXA) lean tissue mass in all four extremities",{"measure":69,"description":70,"timeFrame":54},"Change in Cross-Sectional Area of Trunk and Thigh Muscles","Computed tomography (CT) cross-sectional area of trunk and thigh muscles",{"measure":72,"description":73,"timeFrame":54},"Change in Frailty Phenotype","Fried Frailty Phenotype score, scored from 0 to 5 with higher indicating worse",{"measure":75,"description":76,"timeFrame":54},"Change in Quality of Life","36-Item Short Form Health Survey (SF-36), scored from 0 to 100 with higher indicating better",{"measure":78,"description":79,"timeFrame":54},"Change in Exercise Self-Efficacy","Exercise Self-Efficacy Scale, scored from 0 to 100 with higher indicating better",{"measure":81,"description":82,"timeFrame":54},"Change in Exercise Adherence","FitBit (step count heart rate time), exercise log (movement type, repetitions, load, rate of perceived exertion)",{"measure":84,"description":85,"timeFrame":54},"Change in Tissue Density of Trunk and Thigh Muscles","Computed tomography (CT) attenuation of trunk and thigh muscles",{"measure":87,"description":88,"timeFrame":54},"Change in Visceral Adipose Tissue Cross-Sectional Area","Computed tomography (CT) cross-sectional area at L4","ALL","50 Years","80 Years",false,{"inclusion":94,"exclusion":95,"raw_text":96},[],[],"Inclusion Criteria:\n\n1. Men and women, 50-80 years old\n2. Documented HIV infection on suppressive antiretroviral therapy for at least 1 year with HIV-1 RNA \\\u003C200 copies\u002FmL and CD4+ T cell count \\>200\u002FµL 3\n3. Sedentary lifestyle, defined as self-reported physical activity that breaks a sweat \\\u003C3 days\u002Fweek with no regular resistance exercise in the past 3 months\n4. ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)\n5. 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\n6. Normal mammogram within 2 years (females ≤74 years old) or prostate specific antigen \\\u003C4 ng\u002FmL (males ≤70 years old) per U.S. Preventive Services Task Force (USPSTF) age-appropriate cancer screening guidelines\n7. For females, postmenopausal defined as no menses for ≥12 months and anti-müllerian hormone (AMH) \\\u003C20 pg\u002FmL or history of bilateral oophorectomy at least 3 months ago\n8. Provider approval to participate\n\nExclusion Criteria:\n\n1. Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months\n2. Insulin-like growth factor 1 (IGF-1) z-score \\>2.0\n3. HbA1c \\>8%\n4. Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months\n5. Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months\n6. Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months\n7. Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia\n8. History of hypopituitarism, head irradiation, or other conditions known to affect the GH\u002FIGF-1 axis\n9. Known hypersensitivity to tesamorelin or mannitol\n10. Acute or chronic illness judged by the investigator to represent a contraindication to study participation",[98,99],"ADULT","OLDER_ADULT",[101,116],{"facility":102,"status":7,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"University of Colorado - Anschutz Medical Campus","Aurora","Colorado","80045","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Kristine M. Erlandson, MD","CONTACT","3037244941","kristine.erlandson@cuanschutz.edu",{"lat":114,"lon":115},39.72943,-104.83192,{"facility":12,"status":7,"city":117,"state":118,"zip":119,"country":106,"contacts":120,"geoPoint":129},"Boston","Massachusetts","02114",[121,125],{"name":122,"role":110,"phone":123,"email":124},"Lindsay T Fourman, MD","6176434590","LFourman@mgb.org",{"name":126,"role":110,"phone":127,"email":128},"Julia Johnson","617-724-5545","jjohnson110@mgh.harvard.edu",{"lat":130,"lon":131},42.35843,-71.05977,[133,137],{"name":134,"role":110,"phone":135,"email":136},"Lindsay T. Fourman, MD","617-643-4590","lfourman@mgb.org",{"name":109,"role":110,"phone":138,"email":112},"303-724-4941",[140,142],{"name":134,"affiliation":12,"role":141},"PRINCIPAL_INVESTIGATOR",{"name":109,"affiliation":143,"role":141},"University of Colorado, Denver",[145],{"pmid":146,"type":147,"citation":148},"42419889","DERIVED","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\u002Fbmjopen-2026-120740.",[],{"nct_id":4,"conditions":151,"biomarkers":154},[152,19,153],"Android obesity","HIV Infection",[155,153,156,157],"CD4 Gene","KLK3 Gene","Muellerian-Inhibiting Factor",{"nct_id":4,"found":14,"summary":159,"prompt_version":169},{"design":160,"status":161,"heading":162,"summary":163,"follow_up":164,"word_count":165,"commitments":166,"compensation":167,"drugs_mentioned":168},"This interventional study plans to enroll 100 participants. It will compare tesamorelin plus exercise to a placebo plus exercise.","completed","Tesamorelin and Exercise for Physical Function in HIV","This study is looking at whether the medication tesamorelin, when combined with exercise, can improve physical function and muscle health in adults with HIV. Tesamorelin is already approved to treat abdominal fat in people with HIV. We are enrolling 100 participants, aged 50-80, who have HIV, are on stable treatment, and lead a sedentary lifestyle. The main goal is to see if participants can stand up from a chair faster after 24 weeks. The study status is currently unclear, but we are looking for people who meet these criteria.","The primary outcome is measured at 24 weeks after starting the intervention.",89,"Participants will receive daily subcutaneous injections of either tesamorelin or a placebo, and participate in a home-based, semi-supervised exercise program. The primary endpoint is measured at 24 weeks.","Not stated in the trial record.",[34,47],"v2"]