Status:
RECRUITING
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
HIV-1-infection
Frailty
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
Brief Summary
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 mul...
Eligibility Criteria
Inclusion
- 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)
- Waist circumference ≥102 cm in men and ≥88 cm in women
- 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
- 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
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06554717
Start Date
July 7 2025
End Date
June 30 2028
Last Update
July 29 2025
Active Locations (2)
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1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114