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| 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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
Inclusion Criteria:
Have evidence of abdominal fat accumulation defined by the following anthropometric cut off values:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
| Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
More Information
| 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 |
|
HIV Lipodystrophy Abdominal fat accumulation |
Growth hormone releasing hormone HIV-associated lipodystrophy Treatment Experienced |
|
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 |