TH9507 Extension Study in Patients With HIV- Associated Lipodystrophy

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Lipodystrophy
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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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Changes From Baseline in Fasting Blood Glucose at Week 52

Secondary Outcome

 Changes From Baseline in Visceral Adipose Tissue (VAT) at Week 52

Condition

Lipodystrophy

Intervention

Tesamorelin

Study Arms / Comparison Groups

 Tesamorelin 12 months (T-T)
Description:  Tesamorelin 2 mg/day for 12 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

263

Start Date

August 2007

Completion Date

October 2008

Primary Completion Date

October 2008

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.

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Steven Grinspoon, MD, ,

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT00608023

Organization ID

TH9507-CTR-1012

Responsible Party

Sponsor

Study Sponsor

Theratechnologies

Study Sponsor

Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital

Verification Date

September 2022