Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH): a clinical trial protocol

This paper describes the design of TRIUMPH, a randomised controlled trial testing whether adding tesamorelin to exercise improves physical function in older adults living with HIV. The trial plans to enrol 100 sedentary adults aged 50–80 years with frailty risk and excess abdominal adiposity, randomising them to tesamorelin or placebo alongside a 24-week home-based exercise programme followed by 24 weeks of independent exercise. No results are reported because this is a protocol paper.

Journal article — Randomised controlled trial protocol. Population: Sedentary older adults (aged 50-80 years) living with HIV who are frail or at risk for frailty and have excess abdominal adiposity, in a two-site setting.. Sample size: 100 sedentary older adults (aged 50-80 years) living with HIV. Follow-up: 24-week intervention followed by a 24-week extension phase of independent exercise. Interventions: Tesamorelin as an adjunct to a home-based semisupervised exercise programme.

For researchers studying tesamorelin, this protocol defines the design, comparator, and outcome measures for a randomised, double-blind, placebo-controlled trial of tesamorelin added to exercise in older adults with HIV. It does not establish efficacy, safety, or dosing, because no results are reported.

Key findings

The planned trial will randomise 100 sedentary older adults aged 50-80 years living with HIV to tesamorelin or placebo as an adjunct to exercise.
The study is a two-site, double-blind randomised controlled trial.
Tesamorelin plus exercise will be compared with placebo plus exercise for 24 weeks, followed by a 24-week extension phase of independent exercise.
Clinical endpoints will be assessed at Weeks 24 and 48, and biological endpoints at Week 24.

Limitations

No efficacy results are reported because this is a protocol paper.
The two-site design may limit generalisability.
The home-based, semisupervised exercise programme may lead to variable adherence.
The sample is restricted to sedentary older adults with HIV, frailty risk, and excess abdominal adiposity, so findings may not generalise to other HIV populations.

The record

Journal: BMJ open 16(7): e120740
Published: 2026-07-08
PMID: 42419889 — DOI: 10.1136/bmjopen-2026-120740
MeSH terms: Humans, HIV Infections, Exercise Therapy, Double-Blind Method, Quality of Life, Aged, Aged, 80 and over, Middle Aged, Female, Male, Growth Hormone-Releasing Hormone, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Frailty
Author countries: USA

Peptide profiles: Tesamorelin.

All indexed evidence: Tesamorelin trials & papers.