TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lipodystrophy, HIV Infections

Intervention / Treatment
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* Drug: Tesamorelin
* Drug: Placebo for Tesamorelin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tesamorelin 12 months (T-T)<br>Tesamorelin 2 mg/day for 12 months | Drug: Tesamorelin<br> <br> * Other names: Egrifta;|
| Experimental: Tesamorelin-Placebo (T-P)<br>Tesamorelin 2 mg/day for 6 months - Placebo for 6 months | Drug: Tesamorelin<br> <br> * Other names: Egrifta;Drug: Placebo for Tesamorelin<br> <br> |
| Experimental: Placebo-Tesamorelin (P-T)<br>Placebo 6 months - Tesamorelin 2 mg/day for 6 months | Drug: Tesamorelin<br> <br> * Other names: Egrifta;Drug: Placebo for Tesamorelin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Lipodystrophy, Abdominal fat accumulation, Growth hormone releasing hormone, HIV-associated lipodystrophy, Treatment experienced