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TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Primary Purpose

Lipodystrophy, HIV Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tesamorelin
Placebo for Tesamorelin
Sponsored by
Theratechnologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lipodystrophy focused on measuring HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing hormone, HIV-associated lipodystrophy, Treatment experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Body Positive Inc.
  • Somero, Michael
  • UCLA School of Medicine
  • Office of Dr. Michael Somero
  • University of California
  • Kaiser Permanente
  • UCSF/VA Medical Center
  • AIDS Research Alliance
  • Denver Public Health Department
  • Office of Dr. Gary Richmond
  • Hendry/Glades County Health Departments
  • Infectious Disease Research Institute Inc.
  • AIDS Research Consortium Atlanta (ARCA)
  • Northern Healthcare
  • Northstar Medical
  • Indiana University Department of Medicine
  • Tufts University School of Medicine
  • Massachusetts General Hospital
  • The Research Institute
  • ID Associates
  • AIDS Community Research Initiative of America
  • University of North Carolina at Chapel Hill
  • University Hospitals of Cleveland
  • Central Texas Clinical Research
  • University of Texas Southwestern Medical Center at Dallas
  • Swedish Medical Center
  • C. H. U. Sart-Tilman
  • St-Paul's Hospital
  • McMaster University Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital
  • Centre Hospitalier Universitaire de Santé de l'Estrie
  • Montreal General Hospital
  • Groupe de Recherche en Rhumatologie et maladies osseuses
  • Hôpital Hotel Dieu Lyon
  • Hotel Dieu
  • Hopital Europeen Georges Pompidou
  • Hopital Necker
  • Hosp. Ramon y Cajal
  • Hosp. Clinico San Carlos
  • Hosp.C.U.de Santiago
  • BSUH NHS Trust
  • St Georges Hospital
  • Royal Free Hospital
  • Chelsea and Westminster Hospital
  • St Mary's NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Tesamorelin 12 months (T-T)

Tesamorelin-Placebo (T-P)

Placebo-Tesamorelin (P-T)

Arm Description

Tesamorelin 2 mg/day for 12 months

Tesamorelin 2 mg/day for 6 months - Placebo for 6 months

Placebo 6 months - Tesamorelin 2 mg/day for 6 months

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 23, 2008
Last Updated
September 16, 2022
Sponsor
Theratechnologies
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1. Study Identification

Unique Protocol Identification Number
NCT00608023
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theratechnologies

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipodystrophy, HIV Infections
Keywords
HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing hormone, HIV-associated lipodystrophy, Treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tesamorelin 12 months (T-T)
Arm Type
Experimental
Arm Description
Tesamorelin 2 mg/day for 12 months
Arm Title
Tesamorelin-Placebo (T-P)
Arm Type
Experimental
Arm Description
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Arm Title
Placebo-Tesamorelin (P-T)
Arm Type
Experimental
Arm Description
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
Tesamorelin
Other Intervention Name(s)
Egrifta
Intervention Type
Drug
Intervention Name(s)
Placebo for Tesamorelin
Primary Outcome Measure Information:
Title
Changes From Baseline in Fasting Blood Glucose at Week 52
Description
Blood glucose was determined after an overnight fast. Changes in blood glucose between baseline and Week 52 are reported.
Time Frame
Baseline and Week 52
Title
Changes From Baseline in 2 h Oral Glucose Tolerance Test (OGTT) at Week 52
Description
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.
Time Frame
Baseline and Week 52
Secondary Outcome Measure Information:
Title
Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52
Description
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.
Time Frame
Baseline and Week 52
Other Pre-specified Outcome Measures:
Title
Changes From Baseline in Triglycerides at Week 52
Description
Blood lipid levels were determined under fasting conditions. Changes in triglycerides between baseline and Week 52 are reported.
Time Frame
Baseline and Week 52
Title
Changes From Baseline in Total Cholesterol/HDL Cholesterol Ratio at Week 52
Description
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.
Time Frame
Baseline and Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Grinspoon, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-2170
Country
United States
Facility Name
Body Positive Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Somero, Michael
City
Indio
State/Province
California
ZIP/Postal Code
92201
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Office of Dr. Michael Somero
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of California
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
UCSF/VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
AIDS Research Alliance
City
West Hollywood
State/Province
California
ZIP/Postal Code
90069
Country
United States
Facility Name
Denver Public Health Department
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204-4507
Country
United States
Facility Name
Office of Dr. Gary Richmond
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Hendry/Glades County Health Departments
City
LaBelle
State/Province
Florida
ZIP/Postal Code
33935
Country
United States
Facility Name
Infectious Disease Research Institute Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
AIDS Research Consortium Atlanta (ARCA)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northern Healthcare
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Northstar Medical
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Indiana University Department of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
ID Associates
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
AIDS Community Research Initiative of America
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7215
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75232
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
C. H. U. Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
St-Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
McMaster University Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Santé de l'Estrie
City
Fleurimont
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Groupe de Recherche en Rhumatologie et maladies osseuses
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Hôpital Hotel Dieu Lyon
City
Lyon Cedex 69
ZIP/Postal Code
69288
Country
France
Facility Name
Hotel Dieu
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hosp. Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp.C.U.de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
BSUH NHS Trust
City
Brighton
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
St Georges Hospital
City
London
ZIP/Postal Code
17 0QT
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Chelsea and Westminster Hospital
City
London
ZIP/Postal Code
SW10 9TH
Country
United Kingdom
Facility Name
St Mary's NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28832410
Citation
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.
Results Reference
derived
PubMed Identifier
22495074
Citation
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.
Results Reference
derived
PubMed Identifier
20554713
Citation
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.
Results Reference
derived
PubMed Identifier
20101189
Citation
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.
Results Reference
derived

Learn more about this trial

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

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