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NCT06554717 · ClinicalTrials.gov registry record · Phase 2
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
A Phase 2 study of Aging and HIV-1-infection, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT06554717 is a Phase 2 study of Aging and HIV-1-infection that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06554717, a Phase 2 study of Aging and HIV-1-infection, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG Placebo
- BEHAVIORAL Exercise
- DRUG Tesamorelin
Study Locations (2)
Colorado
- University of Colorado - Anschutz Medical Campus - Aurora
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-07-07 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06554717
The ClinicalTrials.gov registry entry for NCT06554717 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (95% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Aging appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06554717 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Colorado, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06554717 about?
NCT06554717 is a clinical study titled "Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV". 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 wei...
What is the current status of trial NCT06554717?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2025-07-07. Estimated completion is 2028-06-30.
What conditions does trial NCT06554717 study?
This clinical trial studies the following conditions: Aging, HIV-1-infection, Frailty, Abdominal Obesity, Impaired Physical Function.
What interventions are being tested in trial NCT06554717?
The interventions under investigation include: Placebo (DRUG), Exercise (BEHAVIORAL), Tesamorelin (DRUG).
Who is sponsoring clinical trial NCT06554717?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06554717 being conducted?
This trial has 2 study locations across Colorado, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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