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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR EGRIFTA

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Clinical Trials for Egrifta

Trial ID Title Status Sponsor Phase Summary
NCT00608023 TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy Completed Theratechnologies Phase 3 HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.
NCT01579695 Long-term Observational Study in HIV Subjects Exposed to EGRIFTA® Recruiting Theratechnologies N/A The purpose of this observational, 10-year, prospective cohort study is to assess the potential safety concerns of long-term exposure to EGRIFTA® in HIV-infected subjects with abdominal lipohypertrophy compared with a similar group of subjects not exposed to EGRIFTA®.
NCT01591902 Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA® Recruiting Theratechnologies Phase 4 To show the non-inferiority of EGRIFTA® vs. placebo in the development or progression of Diabetic Retinopathy in HIV-infected subjects with concomitant abdominal lipohypertrophy and Type 2 diabetes mellitus (T2DM).
NCT01788462 Egrifta Replacement and Sleep Disordered Breathing Suspended Johns Hopkins University N/A 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Egrifta

Condition Name

Condition Name for Egrifta
Intervention Trials
HIV 3
Lipodystrophy 2
Mild Cognitive Impairment 2
Body Composition 1
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Condition MeSH

Condition MeSH for Egrifta
Intervention Trials
Lipodystrophy 3
Mild Cognitive Impairment 2
Cognition Disorders 2
HIV-Associated Lipodystrophy Syndrome 2
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Clinical Trial Locations for Egrifta

Trials by Country

Trials by Country for Egrifta
Location Trials
United States 47
Canada 4
United Kingdom 1
Spain 1
France 1
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Trials by US State

Trials by US State for Egrifta
Location Trials
Texas 4
California 4
Washington 3
New York 3
New Jersey 3
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Clinical Trial Progress for Egrifta

Clinical Trial Phase

Clinical Trial Phase for Egrifta
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Egrifta
Clinical Trial Phase Trials
Recruiting 5
Completed 2
Not yet recruiting 2
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Clinical Trial Sponsors for Egrifta

Sponsor Name

Sponsor Name for Egrifta
Sponsor Trials
Theratechnologies 4
Johns Hopkins University 2
University of California, San Diego 1
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Sponsor Type

Sponsor Type for Egrifta
Sponsor Trials
Other 7
Industry 4
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Harvard Business School
Dow
Federal Trade Commission
Mallinckrodt
AstraZeneca
Moodys
Julphar

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