# Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH)

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $697,594

## Abstract

Project Summary/Abstract
With the advent of modern antiretroviral therapy, life expectancy in people with HIV (PWH) now approaches that
of the general population. Nonetheless, PWH continue to experience earlier onset and accelerated progression
of complications of aging, including impaired physical function and frailty, which in turn may predispose to
morbidity, mortality, and reduced quality of life. While exercise is the mainstay of therapy to prevent and to treat
these conditions, we have shown that PWH display a limited clinical and biologic response to exercise as
compared to uninfected controls. We have further found that long-term adherence to exercise among PWH is
limited, even following a supervised exercise intervention. Based on these observations, novel pharmacologic
strategies are critically needed to slow or reverse progression of impaired physical function and frailty in HIV with
the potential for broader translation to other high-risk groups. In the proposed clinical trial, we will test for the first
time the novel hypothesis that tesamorelin as an adjunct to exercise (the current standard of care) will ameliorate
impaired physical function and frailty in PWH. Tesamorelin is a growth hormone (GH)-releasing hormone
analogue that is FDA-approved to reduce visceral fat accumulation in PWH with the pivotal Phase III trials led
by our team. Unlike recombinant human GH which leads to non-physiologic, sustained elevations in GH levels,
tesamorelin augments physiologic, pulsatile GH secretion while keeping feedback inhibition intact. Tesamorelin
has a proven track record of safety and efficacy in PWH, having been used clinically for >10 years. As key
Preliminary Data, we have shown that tesamorelin mitigates multiple metabolic features of frailty by increasing
muscle mass, reducing muscle fat, and improving mitochondrial function. In the proposed study, a total of 100
community-dwelling older adults (age 50-80 years) with HIV, ≥1 feature of frailty, and excess abdominal adiposity
will be randomized to tesamorelin or identical placebo in combination with a home-based exercise intervention
for 24 weeks. In a subsequent 24-week extension phase, participants will be monitored off study drug and
supervised exercise to determine the extent to which changes in study endpoints are sustained following
treatment cessation. Outcomes will include measures of physical function (primary endpoint: repeated chair
stand time), muscle mass, exercise adherence and self-efficacy, and quality of life (Aim 1). Biologic effects of
tesamorelin on muscle quality, including muscle fat and mitochondrial function, also will be assessed (Aim 2).
This proposal leverages the complementary expertise of its investigative team in HIV-associated frailty (Multi-PI
Dr. Erlandson, University of Colorado), GH biology (Multi-PI Dr. Fourman, Massachusetts General Hospital),
exercise physiology, advanced imaging, mitochondrial phenotyping, and biostatistics. If our hypothesis is ...

## Key facts

- **NIH application ID:** 10923120
- **Project number:** 1R01AG087809-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Kristine Mace Erlandson
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $697,594
- **Award type:** 1
- **Project period:** 2024-08-15 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10923120

## Citation

> US National Institutes of Health, RePORTER application 10923120, Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV (TRIUMPH) (1R01AG087809-01). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10923120. Licensed CC0.

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