RightFit
RecruitingPhase 2

Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tesamorelin plus exercise improves movement, strength, and muscle health in adults ages 50–80 with HIV. It is for people with low activity levels, signs of frailty, and extra belly fat. Participants receive tesamorelin or a placebo (no-drug treatment) with coached home exercise for 24 weeks, followed by 24 weeks of follow-up.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 50–80.
  • Have HIV and have taken HIV medicines that control the virus for at least 1 year. HIV level must be below 200 copies/mL, and CD4 immune cell count must be above 200/µL.
  • Do activity that causes sweating fewer than 3 days a week, with no regular strength training in the past 3 months.
  • Have at least one study-defined sign of frailty: weakness, slow walking, exhaustion, low activity, or weight loss without trying.
  • Have extra belly fat that meets the study’s waist size or body measurement limits.
  • Women age 74 or younger must have a normal mammogram within 2 years. Men age 70 or younger must have a PSA prostate blood test below 4 ng/mL.
  • Women must have had no periods for at least 12 months and an AMH hormone level below 20 pg/mL, or had both ovaries removed at least 3 months ago.
  • Have approval from your health care provider.

Who can't join

  • Used tesamorelin or another growth hormone treatment within 6 months.
  • Have an IGF-1 growth-related hormone score above 2.0, or an HbA1c blood test showing average blood sugar above 8%.
  • Have had active or suspected cancer within 24 months, except non-melanoma skin cancer.
  • Have testosterone or corticosteroid exposure above normal body levels, or changed the dose of either within 3 months.
  • Changed blood sugar medicine within 3 months.
  • Have active or unstable heart artery disease, chest pain that may be heart-related, or a serious abnormal heartbeat.
  • Have a history of low pituitary gland function, radiation treatment to the head, or another condition affecting growth hormone systems.
  • Have a known allergy to tesamorelin or mannitol, or an illness the study doctor believes makes joining unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

CO

MA