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Completed

NCT Number: NCT00608023

TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

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

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Key information

Conditions

Lipodystrophy Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV-Associated Lipodystrophy Syndrome Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Metabolic Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

C. H. U. Sart-Tilman, Liège, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tesamorelin

Drug

Other names: Egrifta

Placebo for Tesamorelin

Drug

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Theratechnologies

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 6, 2008
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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