TH9507 in Patients With HIV-Associated Lipodystrophy

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Brief Title

TH9507 in Patients With HIV-Associated Lipodystrophy

Official Title

A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of a 2 mg Dose of TH9507, a Growth Hormone Releasing Factor Analog, in HIV Patients With Excess of Abdominal Fat Accumulation

Brief Summary

      HIV lipodystrophy affects a significant proportion of patients treated with combination
      antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation and
      loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin
      resistance. Data from a previous randomized, placebo-controlled trial demonstrated that daily
      administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV patients with
      an excess of abdominal fat accumulation for 12 weeks resulted in decreases in visceral
      adipose tissue (VAT) and trunk fat, with no significant changes in limb fat and subcutaneous
      adipose tissue (SAT). This study is aimed at further assessing the efficacy and safety of 2
      mg TH9507 in a larger population of HIV patients treated with ART and experiencing an excess
      of abdominal fat accumulation.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Visceral adipose tissue (VAT)


Condition

HIV Infections

Intervention

TH9507


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

412

Start Date

June 2005

Completion Date

April 2007

Primary Completion Date

November 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Ages 18 to 65 years inclusive

          -  HIV positive; CD4 cell counts >100 cells/mm3; viral load <10,000 copies/mL (stable for
             8 weeks)

          -  On stable ART regimen for at least 8 weeks prior to randomization

          -  Have evidence of abdominal fat accumulation defined by the following anthropometric
             cut off values:

               -  For males: waist circumference > 95 cm and waist to hip ratio > 0.94;

               -  For females: waist circumference > 94 cm and waist to hip ratio > 0.88.

          -  Females of childbearing potential not pregnant or lactating; normal mammography within
             6 months of study.

          -  Signed informed consent

        Exclusion Criteria:

          -  Body mass index < 20 kg/m2

          -  Opportunistic infection; HIV-related disease within 3 months of study.

          -  History of malignancy; active neoplasm.

          -  Prostate-specific antigen (PSA) >5 ng/mL at screening

          -  Hypopituitarism; history of pituitary tumor/surgery; head irradiation; head trauma
             that has affected the somatotropic axis.

          -  Untreated hypothyroidism

          -  Type 1 diabetics and type 2 diabetics on oral hypoglycemic or insulin sensitizing
             agent within 6 months of study

          -  ALT or AST > 3 x ULN; serum creatinine > 133 mmol/L (1.5 mg/dL); hemoglobin more than
             20 g/L below LLN; fasting blood glucose > 8.33 mmol/L (150 mg/dL); fasting
             triglycerides > 11.3 mmol/L (0.99 g/dL).

          -  Untreated hypertension

          -  Change in anti-hyperlipemic regimen within 3 months prior to study

          -  Change in testosterone regimen and/or supraphysiological dose of testosterone

          -  Estrogen therapy

          -  Anoretics/anorexigenics or anti-obesity agents within 3 months of study

          -  Growth hormone (GH); GH secretagogues; growth hormone releasing factor (GRF) products;
             IGF-1; or IGFBP-3 within 6 months of study.

          -  Drug or alcohol dependence or use of methadone within 6 months of study entry

          -  Participation in a clinical trial with any investigational drug/device within 30 days
             of screening.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Steven Grinspoon, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00123253

Organization ID

TH9507/III/LIPO/010



Study Sponsor

Theratechnologies


Study Sponsor

Steven Grinspoon, MD, Principal Investigator, Massachusetts General Hospital


Verification Date

November 2013