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

Sponsored by:	Theratechnologies
Information provided by:	Theratechnologies
ClinicalTrials.gov Identifier:	NCT00435136

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

MedlinePlus related topics: AIDS

Drug Information available for: Somatropin Somatorelin Tesamorelin Somatotropin

U.S. FDA Resources

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 Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects With Excess Abdominal Fat Accumulation

Further study details as provided by Theratechnologies:

Primary Outcome Measures:

Visceral adipose tissue (VAT)

Secondary Outcome Measures:

Total cholesterol/HDL cholesterol ratio, triglycerides, IGF-1, Patient reported outcomes related to body image

Enrollment:	404
Study Start Date:	January 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Age 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,
For female subjects, 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;
Use of oral hypoglycemic or insulin sensitizing agent within 6 months of study (includes type 1 and drug-treated type 2 diabetes);
ALT or AST >3 x ULN; serum creatinine >133 umol/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: NCT00435136

Show 46 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-1011
Study First Received:	February 6, 2007
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00435136 History of Changes
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Theratechnologies:

HIV
Lipodystrophy
Abdominal fat accumulation

Growth hormone releasing hormone
HIV-associated lipodystrophy
Treatment Experienced

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Metabolic Diseases
Skin Diseases
Hormone Antagonists
Acquired Immunodeficiency Syndrome
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Immunologic Deficiency Syndromes
Virus Diseases

HIV-Associated Lipodystrophy Syndrome
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Growth Hormone-Releasing Hormone
Retroviridae Infections
Metabolic Disorder
Lipid Metabolism Disorders

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 May 07, 2009