Clinical trial NCT00608023: TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
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 GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lipodystrophy
HIV Infections
Keywords: HIV
Lipodystrophy
Abdominal fat accumulation
Growth hormone releasing hormone
HIV-associated lipodystrophy
Treatment experienced
Lead sponsor: Theratechnologies
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Changes From Baseline in Fasting Blood Glucose at Week 52
timeFrame: Baseline and Week 52
measure: Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
timeFrame: Baseline and Week 52
Other outcomes:
measure: Changes From Baseline in Triglycerides at Week 52
timeFrame: Baseline and Week 52
measure: Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
timeFrame: Baseline and Week 52
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Body Positive Inc.
state: Arizona
city: Indio
country: United States
facility: Somero, Michael
state: California
city: Los Angeles
country: United States
facility: UCLA School of Medicine
state: California
city: Palm Springs
country: United States
facility: Office of Dr. Michael Somero
state: California
city: San Francisco
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: UCSF/VA Medical Center
state: California
city: West Hollywood
country: United States
facility: AIDS Research Alliance
state: California
city: Denver
country: United States
facility: Denver Public Health Department
state: Colorado
city: Fort Lauderdale
country: United States
facility: Office of Dr. Gary Richmond
state: Florida
city: LaBelle
country: United States
facility: Hendry/Glades County Health Departments
state: Florida
city: Tampa
country: United States
facility: Infectious Disease Research Institute Inc.
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium Atlanta (ARCA)
state: Georgia
city: Chicago
country: United States
facility: Northern Healthcare
state: Illinois
city: Chicago
country: United States
facility: Northstar Medical
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Department of Medicine
state: Indiana
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Hillsborough
country: United States
facility: ID Associates
state: New Jersey
city: New York
country: United States
facility: AIDS Community Research Initiative of America
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Liège
country: Belgium
facility: C. H. U. Sart-Tilman
city: Vancouver
country: Canada
facility: St-Paul's Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: McMaster University Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Fleurimont
country: Canada
facility: Centre Hospitalier Universitaire de Santé de l'Estrie
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
city: Ste-Foy
country: Canada
facility: Groupe de Recherche en Rhumatologie et maladies osseuses
state: Quebec
city: Lyon Cedex 69
country: France
facility: Hôpital Hotel Dieu Lyon
city: Nantes Cedex 1
country: France
facility: Hotel Dieu
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Hopital Necker
city: Madrid
country: Spain
facility: Hosp. Ramon y Cajal
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos
city: Santiago de Compostela
country: Spain
facility: Hosp.C.U.de Santiago
city: Brighton
country: United Kingdom
facility: BSUH NHS Trust
city: London
country: United Kingdom
facility: St Georges Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St Mary's NHS Trust
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Grinspoon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614.
citation: 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.
citation: 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.
citation: 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.