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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Massachusetts General Hospital
Study ID
NCT06554717
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tesamorelin — DRUG
    Tesamorelin WR 1.28 mg given subcutaneously daily
  • Placebo — DRUG
    Identical placebo injection given subcutaneously daily
  • Exercise — BEHAVIORAL
    Home-based semi-supervised exercise program

Study Details

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.

Key Dates

Start date
Jul 10, 2025
Status verified
May 2026
Primary completion
Jun 16, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tesamorelin Plus Exercise
    Tesamorelin WR 1.28 mg given subcutaneously daily plus home-based semi-supervised exercise intervention
  • Placebo Comparator: Placebo Plus Exercise
    Identical placebo given subcutaneously daily plus home-based semi-supervised exercise intervention

Primary Outcome Measure

Change in Repeated Chair Stand Time [ Time Frame: Baseline to Week 24 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado - Anschutz Medical CampusAuroraColorado80045
Kristine M. Erlandson, MD
[email protected]
3037244941
Massachusetts General HospitalBostonMassachusetts02114
Lindsay T Fourman, MD
[email protected]
6176434590
Julia Johnson
[email protected]
617-724-5545

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By research site
University of Colorado - Anschutz Medical Campus· Aurora, COMassachusetts General Hospital· Boston, MA

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