Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 23, 2008
March 27, 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 ] [ 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.
Visceral adipose tissue (VAT) [ Designated as safety issue: Yes ]
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 ] [ 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.
Total cholesterol/HDL cholesterol ratio, triglyciride reported outcomes related to body image [ Designated as safety issue: No ]
  • 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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   France,   Spain,   United Kingdom
 
NCT00608023
TH9507-CTR-1012
Not Provided
Theratechnologies
Theratechnologies
Not Provided
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
Theratechnologies
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP