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

NCT ID: NCT06554717

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2028-06-30

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 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.

Conditions

HIV-1-infection; Frailty; Impaired Physical Function; Abdominal Obesity; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tesamorelin Plus Exercise

Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention

Group Type: ACTIVE_COMPARATOR

Tesamorelin

Intervention Type: DRUG

Tesamorelin WR 1.28 mg given subcutaneously daily

Exercise

Intervention Type: BEHAVIORAL

Home-based semi-supervised exercise program

Placebo Plus Exercise

Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Identical placebo injection given subcutaneously daily

Exercise

Intervention Type: BEHAVIORAL

Home-based semi-supervised exercise program

Interventions

Tesamorelin

Tesamorelin WR 1.28 mg given subcutaneously daily

Intervention Type: DRUG

Placebo

Identical placebo injection given subcutaneously daily

Intervention Type: DRUG

Exercise

Home-based semi-supervised exercise program

Intervention Type: BEHAVIORAL

Other Intervention Names

Egrifta, TH9507, growth hormone-releasing hormone analogue

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. Waist circumference ≥102 cm in men and ≥88 cm in women

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lindsay Fourman, MD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lindsay T. Fourman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Kristine M. Erlandson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status: RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay T. Fourman, MD

Role: CONTACT

lfourman@mgb.org

617-643-4590

Kristine M. Erlandson, MD

Role: CONTACT

kristine.erlandson@cuanschutz.edu

303-724-4941

Facility Contacts

Kristine M. Erlandson, MD

Role: primary

kristine.erlandson@cuanschutz.edu

303-724-4941

Lindsay T Fourman, MD

Role: primary

LFourman@mgb.org

617-643-4590

Julia Johnson

Role: backup

jjohnson110@mgh.harvard.edu

617-724-5545

Other Identifiers

2024P001703

Identifier Type: -

Identifier Source: org_study_id