TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
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ClinicalTrials.gov Identifier: NCT00608023 |
Recruitment Status :
Completed
First Posted : February 6, 2008
Results First Posted : January 15, 2014
Last Update Posted : September 30, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lipodystrophy HIV Infections | Drug: Tesamorelin Drug: Placebo for Tesamorelin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 263 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | August 2007 |
Actual Primary Completion Date : | October 2008 |
Actual Study Completion Date : | October 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: Tesamorelin 12 months (T-T)
Tesamorelin 2 mg/day for 12 months
|
Drug: Tesamorelin
Other Name: Egrifta |
Experimental: Tesamorelin-Placebo (T-P)
Tesamorelin 2 mg/day for 6 months - Placebo for 6 months
|
Drug: Tesamorelin
Other Name: Egrifta Drug: Placebo for Tesamorelin |
Experimental: Placebo-Tesamorelin (P-T)
Placebo 6 months - Tesamorelin 2 mg/day for 6 months
|
Drug: Tesamorelin
Other Name: Egrifta Drug: Placebo for Tesamorelin |
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608023

Principal Investigator: | Steven Grinspoon, MD | Massachusetts General Hospital |
Responsible Party: | Theratechnologies |
ClinicalTrials.gov Identifier: | NCT00608023 |
Other Study ID Numbers: |
TH9507-CTR-1012 |
First Posted: | February 6, 2008 Key Record Dates |
Results First Posted: | January 15, 2014 |
Last Update Posted: | September 30, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
HIV Lipodystrophy Abdominal fat accumulation |
Growth hormone releasing hormone HIV-associated lipodystrophy Treatment experienced |
Lipodystrophy Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Metabolic Diseases Tesamorelin |
Growth Hormone-Releasing Hormone Growth Substances Physiological Effects of Drugs Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |