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: Tesamorelin Drug: Placebo for Tesamorelin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) 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:

MedlinePlus related topics: HIV/AIDS Hormones

Drug Information available for: Tesamorelin

U.S. FDA Resources

Further study details as provided by Theratechnologies:

Primary Outcome Measures:

Changes From Baseline in Fasting Blood Glucose at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported.

Secondary Outcome Measures:

Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported.

Other Outcome Measures:

Changes From Baseline in Triglycerides at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported.


Enrollment:	263
Study Start Date:	August 2007
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tesamorelin 12 months (T-T) Tesamorelin 2 mg/day for 12 months	Drug: Tesamorelin Other Name: Egrifta
Experimental: Tesamorelin-Placebo (T-P) Tesamorelin 2 mg/day for 6 months - Placebo for 6 months	Drug: Tesamorelin Other Name: Egrifta Drug: Placebo for Tesamorelin
Experimental: Placebo-Tesamorelin (P-T) Placebo 6 months - Tesamorelin 2 mg/day for 6 months	Drug: Tesamorelin Other Name: Egrifta Drug: Placebo for Tesamorelin

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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. doi: 10.1093/cid/cis251. 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. doi: 10.1210/jc.2010-0490. 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;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff.


Responsible Party:	Theratechnologies
ClinicalTrials.gov Identifier:	NCT00608023 History of Changes
Other Study ID Numbers:	TH9507-CTR-1012
Study First Received:	January 23, 2008
Results First Received:	November 27, 2013
Last Updated:	March 27, 2014
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 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 Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Hormones Growth Hormone-Releasing Hormone Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016