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Tesamorelin

Egrifta, TH9507

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Studies 64
Trials 24
Withdrawn OBSERVATIONAL NCT01788462

Egrifta Replacement and Sleep Disordered Breathing

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Sleep-disordered breathing is characterized primarily by partial or total upper airway obstruction during sleep. The most common form of sleep-disordered breathing is obstructive sleep apnea (OSA) due to recurrent collapse of the upper airway with the onset of sleep state. The major risk factors associated with the development of sleep apnea are obesity and male sex. The investigators have also found a high prevalence of OSA in HIV infected men and women, particularly among those with central lipohypertrophy, which is a common finding in HIV-infected persons receiving antiretroviral therapy. Currently, our overall hypothesis is that visceral adiposity, as seen in HIV-infected persons with central lipohypertrophy, alters both mechanical properties and compensatory neuromuscular responses leading to upper airway obstruction. Based on our most recent findings in the non-HIV population, the investigators demonstrate that obesity is associated with elevations in the upper airway load (passive Pcrit) that are counterbalanced by compensatory upper airway neural responses. Moreover, the investigators have found that female sex, peripheral adiposity, and younger age are associated with increased compensatory neuromuscular responses, while male sex, central adiposity, and older age are associated with blunted compensatory responses. The loss of the compensatory neuromuscular responses leads to obstructive sleep apnea. Among HIV-infected patients with central lipohypertrophy, tesamorelin (Egrifta), a growth hormone releasing hormone (GHRH) analogue, is approved for the reduction of visceral adipose tissue. The investigators hypothesize that tesamorelin therapy will reverse both the mechanical and neurocompensatory alterations associated with increased central obesity. In this project the investigators will determine whether tesamorelin affects sleep apnea severity and compensatory neuromuscular responses of the upper airway on sleep and breathing in men and women with HIV infection. The proposed studies are designed to elucidate the pathophysiologic basis for the development of obstructive sleep apnea in this population. The studies also provide insights into the neurohumoral regulation of upper airway function, and potentially new approaches to the treatment for sleep-disordered breathing.

Interventions

Name: Tesamorelin (Egrifta)
Type: DRUG
Description: We will observe the effects of Tesamorelin on patients with HIV and lipodystrophy.

Primary Outcomes

Measure: Changes in Sleep Apnea Severity
TimeFrame: Subjects will be evaluated prior to initiating tesamorelin therapy (baseline)
Description: Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
Measure: Changes in Sleep Apnea Severity
TimeFrame: Subjects will be evaluated at three months
Description: Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
Measure: Changes in Sleep Apnea Severity
TimeFrame: Subjects will be evaluated at six months
Description: Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.
Measure: Changes in Sleep Apnea Severity
TimeFrame: Subjects will be evaluated at one year
Description: Sleep apnea severity (AHI), change in sleep apnea severity (∆ AHI), and compensatory neuromuscular responses (AT/DBT, ∆ AT/DBT) will be the primary outcome variables.

Trial Information

NCT ID

NCT01788462

Status

Withdrawn

Study Type

OBSERVATIONAL

Sponsor

Johns Hopkins University

Last Updated

December 15, 2025

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