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CLINICAL TRIALS PROFILE FOR EGRIFTA

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All Clinical Trials for Egrifta

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00608023	TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy	Completed	Theratechnologies	Phase 3	2007-08-01	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	2013-02-01	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	2012-06-01	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).

Clinical Trial Conditions for Egrifta

Condition Name

Condition Name for Egrifta
Intervention	Trials
HIV	3
Mild Cognitive Impairment	2
Lipodystrophy	2

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Condition MeSH

Condition MeSH for Egrifta
Intervention	Trials
Lipodystrophy	3
HIV-Associated Lipodystrophy Syndrome	2
HIV Infections	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
Belgium	1
United Kingdom	1
Spain	1

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Trials by US State

Trials by US State for Egrifta
Location	Trials
California	4
Texas	4
Florida	3
Washington	3
New York	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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	1

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Sponsor Type

Sponsor Type for Egrifta
Sponsor	Trials
Other	7
Industry	4
NIH	2

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