Tesamorelin plus exercise to improve physical function in older adults with HIV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 randomized study will enroll adults aged 50–80 with HIV who have been on suppressive antiretroviral therapy for at least one year, meet waist circumference thresholds for abdominal obesity, report a sedentary lifestyle, and meet at least one Fried frailty criterion. Participants will receive either tesamorelin or placebo while participating in a structured exercise program over a 24-week intervention period, with regular measures of muscle mass, strength, and physical performance. The study is conducted at Massachusetts General Hospital and the University of Colorado Anschutz Medical Campus and includes site visits for assessments. Outcomes will compare changes in physical function and muscle health between the tesamorelin and placebo groups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women, 50-80 years old
2. 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
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
4. ≥1 Fried frailty criterion (weakness, slow gait speed, exhaustion, decreased physical activity, or unintentional weight loss as defined by specific thresholds)
5. 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
6. 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
7. 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
8. Provider approval to participate

Exclusion Criteria:

1. Use of tesamorelin or other growth hormone (GH)-based therapy within 6 months
2. Insulin-like growth factor 1 (IGF-1) z-score \>2.0
3. HbA1c \>8%
4. Active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months
5. Supraphysiologic testosterone or corticosteroid exposure, or change in exogenous testosterone or corticosteroid dose within 3 months
6. Change in glucose-lowering medication (e.g., glucagon-like peptide-1 receptor agonists) within 3 months
7. Active or unstable coronary artery disease, chest pain suspicious for angina, or serious arrythmia
8. History of hypopituitarism, head irradiation, or other conditions known to affect the GH/IGF-1 axis
9. Known hypersensitivity to tesamorelin or mannitol
10. Acute or chronic illness judged by the investigator to represent a contraindication to study participation

Where it's running

• University of Colorado - Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Lindsay T. Fourman, MD — Massachusetts General Hospital
• Study coordinator: Lindsay T. Fourman, MD
• Email: lfourman@mgb.org
• Phone: 617-643-4590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.