TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

September 16, 2022 updated by: Theratechnologies

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

263

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • C. H. U. Sart-Tilman
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St-Paul's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Health Sciences Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Santé de l'Estrie
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
      • Ste-Foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Rhumatologie et Maladies Osseuses
  • France
      • Lyon Cedex 69, France, 69288
        • Hopital Hotel Dieu Lyon
      • Nantes Cedex 1, France, 44093
        • Hotel Dieu
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou
      • Paris, France, 75743
        • Hôpital Necker
  • Spain
      • Madrid, Spain, 28040
        • Hosp. Clinico San Carlos
      • Madrid, Spain, 28034
        • Hosp. Ramon y Cajal
      • Santiago de Compostela, Spain, 15706
        • Hosp.C.U.de Santiago
  • United Kingdom
      • Brighton, United Kingdom, BN2 1ES
        • BSUH NHS Trust
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW10 9TH
        • Chelsea and Westminster Hospital
      • London, United Kingdom, W2 1NY
        • St Mary's NHS Trust
      • London, United Kingdom, 17 0QT
        • St Georges Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-2170
        • University of Alabama At Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Body Positive Inc.
    • California
      • Indio, California, United States, 92201
        • Somero, Michael
      • Los Angeles, California, United States, 90035
        • UCLA School of Medicine
      • Palm Springs, California, United States, 92262
        • Office of Dr. Michael Somero
      • San Francisco, California, United States, 94118
        • Kaiser Permanente
      • San Francisco, California, United States, 94110
        • University of California
      • San Francisco, California, United States, 94121
        • UCSF/VA Medical Center
      • West Hollywood, California, United States, 90069
        • AIDS Research Alliance
    • Colorado
      • Denver, Colorado, United States, 80204-4507
        • Denver Public Health Department
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Office of Dr. Gary Richmond
      • LaBelle, Florida, United States, 33935
        • Hendry/Glades County Health Departments
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium Atlanta (ARCA)
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Northern Healthcare
      • Chicago, Illinois, United States, 60657
        • Northstar Medical
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Department of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine
      • Springfield, Massachusetts, United States, 01107
        • The Research Institute
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID Associates
    • New York
      • New York, New York, United States, 10018
        • AIDS Community Research Initiative of America
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7215
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Dallas, Texas, United States, 75232
        • University of Texas Southwestern Medical Center at Dallas
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
Drug: Tesamorelin
Other Names:
  • Egrifta
Experimental: Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
Drug: Tesamorelin
Other Names:
  • Egrifta
Drug: Placebo for Tesamorelin
Experimental: Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Drug: Tesamorelin
Other Names:
  • Egrifta
Drug: Placebo for Tesamorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 52
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.
Baseline and Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 52

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 52
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.
Baseline and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theratechnologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

January 23, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

February 6, 2008

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH9507-CTR-1012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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