TH9507 in Patients With HIV-Associated Lipodystrophy

This study has been completed.
Sponsor:
Information provided by:
Theratechnologies
ClinicalTrials.gov Identifier:
NCT00123253
First received: July 20, 2005
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
HIV Infections
Lipodystrophy
Drug: TH9507
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Theratechnologies:

Primary Outcome Measures:
  • Visceral adipose tissue (VAT)

Enrollment: 412
Study Start Date: June 2005
Study Completion Date: April 2007
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123253

  Show 42 Study Locations
Sponsors and Collaborators
Theratechnologies
Investigators
Principal Investigator: Steven Grinspoon, MD Massachusetts General Hospital
  More Information

No publications provided by Theratechnologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00123253     History of Changes
Obsolete Identifiers: NCT00435136
Other Study ID Numbers: TH9507/III/LIPO/010
Study First Received: July 20, 2005
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Theratechnologies:
HIV
Lipodystrophy
Abdominal fat accumulation
Growth hormone releasing factor/Growth hormone releasing hormone
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Lipodystrophy
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Skin Diseases
Skin Diseases, Metabolic
Slow Virus Diseases
Virus Diseases
Growth Hormone-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014