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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tesamorelin 12 months (T-T) | Experimental | Tesamorelin 2 mg/day for 12 months |
|
| Tesamorelin-Placebo (T-P) | Experimental | Tesamorelin 2 mg/day for 6 months - Placebo for 6 months |
|
| Placebo-Tesamorelin (P-T) | Experimental | Placebo 6 months - Tesamorelin 2 mg/day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tesamorelin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Fasting Blood Glucose at Week 52 | Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported. | Baseline and Week 52 |
| Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 | Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in Triglycerides at Week 52 | Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported. | Baseline and Week 52 |
| Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Grinspoon, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-2170 | United States | ||
| Body Positive Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28832410 | Derived | Fourman LT, Czerwonka N, Feldpausch MN, Weiss J, Mamputu JC, Falutz J, Morin J, Marsolais C, Stanley TL, Grinspoon SK. Visceral fat reduction with tesamorelin is associated with improved liver enzymes in HIV. AIDS. 2017 Oct 23;31(16):2253-2259. doi: 10.1097/QAD.0000000000001614. | |
| 22495074 | Derived | Stanley TL, Falutz J, Marsolais C, Morin J, Soulban G, Mamputu JC, Assaad H, Turner R, Grinspoon SK. Reduction in visceral adiposity is associated with an improved metabolic profile in HIV-infected patients receiving tesamorelin. Clin Infect Dis. 2012 Jun;54(11):1642-51. doi: 10.1093/cid/cis251. Epub 2012 Apr 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tesamorelin (52 Weeks) | Tesamorelin 2 mg/day for 52 Weeks |
| FG001 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo for Tesamorelin | Drug |
|
Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported. |
| Baseline and Week 52 |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Somero, Michael | Indio | California | 92201 | United States |
| UCLA School of Medicine | Los Angeles | California | 90035 | United States |
| Office of Dr. Michael Somero | Palm Springs | California | 92262 | United States |
| University of California | San Francisco | California | 94110 | United States |
| Kaiser Permanente | San Francisco | California | 94118 | United States |
| UCSF/VA Medical Center | San Francisco | California | 94121 | United States |
| AIDS Research Alliance | West Hollywood | California | 90069 | United States |
| Denver Public Health Department | Denver | Colorado | 80204-4507 | United States |
| Office of Dr. Gary Richmond | Fort Lauderdale | Florida | 33316 | United States |
| Hendry/Glades County Health Departments | LaBelle | Florida | 33935 | United States |
| Infectious Disease Research Institute Inc. | Tampa | Florida | 33614 | United States |
| AIDS Research Consortium Atlanta (ARCA) | Atlanta | Georgia | 30308 | United States |
| Northern Healthcare | Chicago | Illinois | 60657 | United States |
| Northstar Medical | Chicago | Illinois | 60657 | United States |
| Indiana University Department of Medicine | Indianapolis | Indiana | 46202 | United States |
| Tufts University School of Medicine | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| The Research Institute | Springfield | Massachusetts | 01107 | United States |
| ID Associates | Hillsborough | New Jersey | 08844 | United States |
| AIDS Community Research Initiative of America | New York | New York | 10018 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7215 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Central Texas Clinical Research | Austin | Texas | 78705 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75232 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| C. H. U. Sart-Tilman | Liège | 4000 | Belgium |
| St-Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| McMaster University Health Sciences Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre Hospitalier Universitaire de Santé de l'Estrie | Fleurimont | Quebec | J1H 5N4 | Canada |
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Groupe de Recherche en Rhumatologie et maladies osseuses | Ste-Foy | Quebec | G1V 3M7 | Canada |
| Hôpital Hotel Dieu Lyon | Lyon | 69288 | France |
| Hotel Dieu | Nantes | 44093 | France |
| Hopital Europeen Georges Pompidou | Paris | 75015 | France |
| Hopital Necker | Paris | 75743 | France |
| Hosp. Ramon y Cajal | Madrid | 28034 | Spain |
| Hosp. Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp.C.U.de Santiago | Santiago de Compostela | 15706 | Spain |
| BSUH NHS Trust | Brighton | BN2 1ES | United Kingdom |
| St Georges Hospital | London | 17 0QT | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9TH | United Kingdom |
| St Mary's NHS Trust | London | W2 1NY | United Kingdom |
| 20554713 | Derived | Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, Marsolais C, Turner R, Grinspoon S. Effects of tesamorelin (TH9507), a growth hormone-releasing factor analog, in human immunodeficiency virus-infected patients with excess abdominal fat: a pooled analysis of two multicenter, double-blind placebo-controlled phase 3 trials with safety extension data. J Clin Endocrinol Metab. 2010 Sep;95(9):4291-304. doi: 10.1210/jc.2010-0490. Epub 2010 Jun 16. |
| 20101189 | Derived | Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, Berger D, Somero M, Moyle G, Brown S, Martorell C, Turner R, Grinspoon S. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010 Mar;53(3):311-22. doi: 10.1097/QAI.0b013e3181cbdaff. |
| FG002 | Placebo-Tesamorelin (P-T) | Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tesamorelin 52 Weeks | Tesamorelin 2 mg/day for 52 weeks |
| BG001 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks |
| BG002 | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 | Visceral adipose tissue (VAT) was assessed by computerized tomography (CT) scan using a single-slice. Changes in VAT between baseline and Week 52 are reported. | All data were included in the analysis by intention to treat principles. Intent to treat populations were defined as all randomized subjects who were exposed to study drug (i.e injection of at least 1 dose of study drug). | Posted | Mean | Standard Deviation | cm^2 | Baseline and Week 52 |
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| Other Pre-specified | Changes From Baseline in Triglycerides at Week 52 | Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52 |
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| Other Pre-specified | Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 | Blood lipid levels were determined under fasting conditions. Total Cholesterol/HDL Cholesterol Ratio was obtained by dividing the total cholesterol value by the value of the HDL cholesterol. Changes between baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | ratio | Baseline and Week 52 |
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| Primary | Changes From Baseline in Fasting Blood Glucose at Week 52 | Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52 |
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| Primary | Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 | Glucose tolerance was determined after an overnight fast using standard 75 gram-oral glucose tolerance test (OGTT) with glucose measured at timepoints 0, 30, 60, 90 and 120. Changes in glucose tolerance between baseline and Week 52 are reported. | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 52 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tesamorelin 52 Weeks | Tesamorelin 2 mg/day for 52 weeks | 3 | 92 | 17 | 92 | ||
| EG001 | Tesamorelin (26 Weeks) - Placebo (26 Weeks) | Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks | 1 | 85 | 11 | 85 | ||
| EG002 | Placebo (26 Weeks) - Tesamorelin (26 Weeks) | Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks | 3 | 86 | 28 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinopathy | Eye disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Hodgkin disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Injection site erythema | General disorders | Systematic Assessment |
| ||
| Injection site pain | General disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Musculosketal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Paresthesia | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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As this trial was completed in October 2008 hence, the primary Completion Date is prior to January 18, 2017, therefore the Protocol, and Statistical Analysis Plan have not been uploaded to the Document Section.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marilyn de Chantal, Global Senior Medical Director | Theratechnologies | 1 438-315-6624 | Mdechantal@theratech.com |
| ID | Term |
|---|---|
| D008060 | Lipodystrophy |
| D015658 | HIV Infections |
| D039682 | HIV-Associated Lipodystrophy Syndrome |
| ID | Term |
|---|---|
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C479538 | tesamorelin |
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| Male |
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