TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

• ClinicalTrials.gov Identifier: NCT00608023
• Recruitment Status: Completed
• First Posted: February 6, 2008
• Results First Posted: January 15, 2014
• Last Update Posted: September 30, 2022
• Sponsor: Theratechnologies
• Information provided by (Responsible Party): Theratechnologies

Tracking Information

• First Submitted Date: January 23, 2008
• First Posted Date: February 6, 2008
• Results First Submitted Date: November 27, 2013
• Results First Posted Date: January 15, 2014
• Last Update Posted Date: September 30, 2022
• Study Start Date: August 2007
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2014)

• 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.

• Original Primary Outcome Measures (submitted: January 23, 2008): Visceral adipose tissue (VAT)

Current Secondary Outcome Measures (submitted: March 27, 2014)

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.

• Original Secondary Outcome Measures (submitted: January 23, 2008): Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image

Current Other Pre-specified Outcome Measures (submitted: March 27, 2014)

• 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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
• Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled Extension Study Assessing the Efficacy and Long-term Safety of a 2 mg Dose of TH9507, a GHRH Analog, in HIV Subjects With Excess Abdominal Fat Accumulation
• Brief Summary: 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
• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Lipodystrophy
• HIV Infections

Intervention

• Drug: Tesamorelin
  Other Name: Egrifta
• Drug: Placebo for Tesamorelin

Study Arms

• 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

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2014): 263
• Original Estimated Enrollment (submitted: January 23, 2008): 300
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, France, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT00608023
• Other Study ID Numbers: TH9507-CTR-1012
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Theratechnologies
• Original Responsible Party: Not Provided
• Current Study Sponsor: Theratechnologies
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Steven Grinspoon, MD; Massachusetts General Hospital

• PRS Account: Theratechnologies
• Verification Date: September 2022