TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theratechnologies
ClinicalTrials.gov Identifier:
NCT00608023
First received: January 23, 2008
Last updated: March 27, 2014
Last verified: March 2014
  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: Tesamorelin
Drug: Placebo for Tesamorelin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 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:
  • Changes From Baseline in Fasting Blood Glucose at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Changes From Baseline in Triglycerides at Week 52 [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 263
Study Start Date: August 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Drug: Tesamorelin
Other Name: Egrifta
Experimental: Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Drug: Tesamorelin
Other Name: Egrifta
Drug: Placebo for Tesamorelin
Experimental: Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Drug: Tesamorelin
Other Name: Egrifta
Drug: Placebo for Tesamorelin

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608023

  Show 49 Study Locations
Sponsors and Collaborators
Theratechnologies
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided by Theratechnologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Theratechnologies
ClinicalTrials.gov Identifier: NCT00608023     History of Changes
Other Study ID Numbers: TH9507-CTR-1012
Study First Received: January 23, 2008
Results First Received: November 27, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theratechnologies:
HIV
Lipodystrophy
Abdominal fat accumulation
Growth hormone releasing hormone
HIV-associated lipodystrophy
Treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014