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

What Was Tested

In this phase 2 trial, researchers set out to test Tesamorelin.

It had two arms (groups): Tesamorelin Plus Exercise (active comparator) and Placebo Plus Exercise (placebo comparator).

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

The registry classes the interventions as behavioral and drug.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 50 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men and women, 50-80 years old. 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. 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. 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. Provider approval to participate.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: use of tesamorelin or other growth hormone (gh)-based therapy within 6 months; insulin-like growth factor 1 (igf-1) z-score \>2.0; active or suspected malignancy (with the exception of non-melanoma skin cancer) within 24 months.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Tesamorelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tesamorelin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Tesamorelin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-07-10 with completion listed for 2028-06-16.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Repeated Chair Stand Time (time frame: Baseline to Week 24).

It also tracked 11 secondary outcomes, for example Change in Standard and Modified Short Physical Performance Battery (SPPB), Change in 1-Repetition Maximum Leg Press, Change in 400-Meter Walk Time, Change in Appendicular Lean Tissue Mass, Change in Cross-Sectional Area of Trunk and Thigh Muscles and Change in Frailty Phenotype.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tesamorelin in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tesamorelin compound page, all human trials.