| January 23, 2008
|
| February 6, 2008
|
| November 27, 2013
|
| January 15, 2014
|
| April 17, 2014
|
| August 2007
|
| October 2008 (Final data collection date for primary outcome measure)
|
- Changes From Baseline in Fasting Blood Glucose at Week 52 [ Time Frame: Baseline and Week 52 ]
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
- Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52 [ Time Frame: Baseline and 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.
|
| Visceral adipose tissue (VAT)
|
| Complete list of historical versions of study NCT00608023 on ClinicalTrials.gov Archive Site
|
| Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 [ Time Frame: Baseline and 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.
|
| Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image
|
- Changes From Baseline in Triglycerides at Week 52 [ Time Frame: Baseline and Week 52 ]
Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
- Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52 [ Time Frame: Baseline and 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.
|
| Not Provided
|
| |
| TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy |
| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment |
- Lipodystrophy
- HIV Infections
|
- Drug: Tesamorelin
Other Name: Egrifta
- Drug: Placebo for Tesamorelin
|
- Experimental: Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Intervention: Drug: Tesamorelin
- Experimental: Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Interventions:
- Drug: Tesamorelin
- Drug: Placebo for Tesamorelin
- Experimental: Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Interventions:
- Drug: Tesamorelin
- Drug: Placebo for Tesamorelin
|
- 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.
- 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.
- 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.
|
| |
| Completed |
| 263 |
| October 2008 |
| October 2008 (Final data collection date for primary outcome measure) |
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 65 Years (Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Belgium, Canada, France, Spain, United Kingdom, United States |
| |
| |
| NCT00608023 |
| TH9507-CTR-1012 |
| Not Provided |
| Not Provided |
| Not Provided |
| Theratechnologies |
| Theratechnologies |
| Not Provided |
| Principal Investigator: |
Steven Grinspoon, MD |
Massachusetts General Hospital |
|
| Theratechnologies |
| March 2014 |
