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TH9507 in Patients With HIV-Associated Lipodystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00123253
Recruitment Status : Completed
First Posted : July 22, 2005
Last Update Posted : November 27, 2013
Sponsor:
Information provided by:
Theratechnologies

Tracking Information
First Submitted Date  ICMJE July 20, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date November 27, 2013
Study Start Date  ICMJE June 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2005)
Visceral adipose tissue (VAT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TH9507 in Patients With HIV-Associated Lipodystrophy
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • HIV Infections
  • Lipodystrophy
Intervention  ICMJE Drug: TH9507
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2013)
412
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00123253
Other Study ID Numbers  ICMJE TH9507/III/LIPO/010
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Theratechnologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
PRS Account Theratechnologies
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP