TH9507 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 and loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2 mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess of abdominal fat accumulation.

Condition	Intervention	Phase
HIV Infections Lipodystrophy	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 Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of 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)

Study Start Date:	June 2005
Estimated Study Completion Date:	September 2006

Eligibility

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

Criteria

Inclusion Criteria:

Ages 18 to 65 years inclusive
HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for 8 weeks)
On stable ART regimen for at least 8 weeks prior to randomization
Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
- For males: waist circumference > 95 cm and waist to hip ratio > 0.94;
- For females: waist circumference > 94 cm and waist to hip ratio > 0.88.
Females of childbearing potential not pregnant or lactating; normal mammography within 6 months of study.
Signed informed consent

Exclusion Criteria:

Body mass index < 20 kg/m2
Opportunistic infection; HIV-related disease within 3 months of study.
History of malignancy; active neoplasm.
Prostate-specific antigen (PSA) >5 ng/mL at screening
Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma that has affected the somatotropic axis.
Untreated hypothyroidism
Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing agent within 6 months of study
ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than 20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting triglycerides > 11.3 mmol/L (0.99 g/dL).
Untreated hypertension
Change in anti-hyperlipemic regimen within 3 months prior to study
Change in testosterone regimen and/or supraphysiological dose of testosterone
Estrogen therapy
Anoretics/anorexigenics or anti-obesity agents within 3 months of study
Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products; IGF-1; or IGFBP-3 within 6 months of study.
Drug or alcohol dependence or use of methadone within 6 months of study entry
Participation in a clinical trial with any investigational drug/device within 30 days of screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123253

Show 42 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, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007 Dec 6;357(23):2359-70.

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:	NCT00123253 History of Changes
Obsolete Identifiers:	NCT00435136
Other Study ID Numbers:	TH9507/III/LIPO/010
Study First Received:	July 20, 2005
Last Updated:	January 18, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Theratechnologies:

HIV
Lipodystrophy
Abdominal fat accumulation
Growth hormone releasing factor/Growth hormone releasing hormone
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
Hormones
Growth Hormone-Releasing Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 07, 2013