TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lipodystrophy HIV Infections	Drug: TH9507	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Somatropin Tesamorelin

U.S. FDA Resources

Further study details as provided by Theratechnologies:

Primary Outcome Measures:

Visceral adipose tissue (VAT) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
Signed informed consent before any trial-related activities.

Exclusion Criteria:

Fasting blood glucose >8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608023

Show 49 Study Locations

Sponsors and Collaborators

Theratechnologies

Investigators

Principal Investigator:

Steven Grinspoon, MD

Massachusetts General Hospital

More Information

No publications provided by Theratechnologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. Epub 2012 Apr 10.

Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. Epub 2010 Jun 16.

Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar 1;53(3):311-22.

ClinicalTrials.gov Identifier:	NCT00608023 History of Changes
Other Study ID Numbers:	TH9507-CTR-1012
Study First Received:	January 23, 2008
Last Updated:	November 22, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theratechnologies:

HIV
Lipodystrophy
Abdominal fat accumulation

Growth hormone releasing hormone
HIV-associated lipodystrophy
Treatment experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes

Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013