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

Sponsored by:	Theratechnologies
Information provided by:	Theratechnologies
ClinicalTrials.gov Identifier:	NCT00123253

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 III

MedlinePlus related topics: AIDS

Drug Information available for: Somatotropin Somatropin Somatorelin Sermorelin Sermorelin acetate Tesamorelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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

Publications indexed to this study:

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.

Study ID Numbers:	TH9507/III/LIPO/010
Study First Received:	July 20, 2005
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00123253
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

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Metabolic Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
HIV-Associated Lipodystrophy Syndrome

HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Metabolic disorder
Growth Hormone-Releasing Hormone
Retroviridae Infections
Lipid Metabolism Disorders

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Skin Diseases, Metabolic
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Lentivirus Infections
Infection
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009