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TH9507 in Patients With HIV-Associated Lipodystrophy
This study is ongoing, but not recruiting participants.
First Received: February 6, 2007   Last Updated: January 18, 2008   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


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

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233-7333
United States, Arizona
Body Positive, Inc.
Phoenix, Arizona, United States, 85006
United States, California
AIDS Research Alliance
West Hollywood, California, United States, 90069
UCLA School of Medicine
Los Angeles, California, United States, 90035
Kaiser Permanente
San Francisco, California, United States, 94118
UCSF/VA Medical Center
San Francisco, California, United States, 94121
University of California, San Francisco
San Francisco, California, United States, 94110
Somero, Michael
Indio, California, United States, 92201
United States, Colorado
Denver Public Health Department
Denver, Colorado, United States, 80204-4507
United States, Florida
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States, 33614
Richmond, Gary
Ft. Lauderdale, Florida, United States, 33316
Hendry/Glades County Health Departments
Labelle, Florida, United States, 33935
United States, Georgia
AIDS Research Consortium of Atlanta, Inc.
Atlanta, Georgia, United States, 30308
United States, Illinois
Northstar Medical
Chicago, Illinois, United States, 60657
United States, Indiana
Indiana University Department of Medicine
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
The Research Institute
Springfield, Massachusetts, United States, 01107
United States, New Jersey
ID Associates
Hillsborough, New Jersey, United States, 08844
United States, New York
ACRIA
New York, New York, United States, 10018
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27611
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75232
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Belgium
C. H. U. Sart-Tilman
Liège, Belgium, 4000
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
McMaster University Health Sciences Center
Hamilton, Ontario, Canada, L8N 3Z5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Groupe de Recherche en Rhumatologie et maladies osseuses
Ste-Foy, Quebec, Canada, G1V 3M7
Centre Hospitalier Universitaire de Santé de l'Estrie
Fleurimont, Quebec, Canada, J1H 5N4
France
Hopital Europeen Georges Pompidou
Paris, France, 75015
Hopital Hotel Dieu Lyon
Lyon, France, 69288
Hopital Necker
Paris, France, 75743
Hotel Dieu
Nantes Cedex 1, France, 44093
Spain
Hosp. Ramon y Cajal
Madrid, Spain, 28034
Hosp.C.U.de Santiago
A Coruna, Spain, 15706
Hosp. Clinico San Carlos
Madrid, Spain, 28040
United Kingdom
St Mary's NHS Trust
London, United Kingdom, W2 1NY
Bsuh NHS Trust
Brighton, United Kingdom, BN2 1ES
Royal Free Hospital
London, United Kingdom, NW3 2QG
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9TH
St Georges Hospital
London, United Kingdom, 17 0QT
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

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 November 30, 2009