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

Sponsor:	Theratechnologies
Information provided by:	Theratechnologies
ClinicalTrials.gov Identifier:	NCT00608023

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 III

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

Drug Information available for: Somatropin Somatorelin Sermorelin Tesamorelin Somatotropin

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

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 51 Study Locations

Sponsors and Collaborators

Theratechnologies

Investigators

Principal Investigator:

Steven Grinspoon, MD

Massachusetts General Hospital

More Information

No publications provided

Study ID Numbers:	TH9507-CTR-1012
Study First Received:	January 23, 2008
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00608023 History of Changes
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:

RNA Virus Infections
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Slow Virus Diseases
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Acquired Immunodeficiency Syndrome
Hormones, Hormone Substitutes, and Hormone Antagonists
Infection
Hormones
Pharmacologic Actions

Immunologic Deficiency Syndromes
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Lentivirus Infections
Growth Hormone-Releasing Hormone
Retroviridae Infections
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 09, 2010