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A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity

This study has been terminated.
Sponsor:
Information provided by:
ConjuChem
ClinicalTrials.gov Identifier:
NCT00267527
First received: December 20, 2005
Last updated: October 12, 2006
Last verified: October 2006

December 20, 2005
October 12, 2006
December 2005
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Complete list of historical versions of study NCT00267527 on ClinicalTrials.gov Archive Site
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A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study to Evaluate the Efficacy and Safety of CJC 1295 Administered for 12 Weeks in HIV Infected Patients With HIV Associated Visceral Obesity

This is a multicenter, randomized, placebo-controlled, double-blind, Phase 2 study. Patients will be treated for a total of 12 weeks. There will be a 6 week follow-up period after the treatment period ends. Patients will be randomly assigned to low dose CJC 1295, high dose CJC 1295 or placebo.

The objective is to assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC 1295 in patients with human immunodeficiency virus (HIV) associated visceral obesity.

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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Obesity
  • HIV Infections
Drug: CJC 1295
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
September 2006
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Inclusion Criteria:

  • Age 18-65 on stable antiviral regimen
  • Documented HIV infection
  • HIV associated visceral obesity
  • Body mass index (BMI) > 24 and < 30 kg/m2

Exclusion Criteria:

  • Diabetes
  • Use of growth hormone (GH) or other GH secretagogues
  • Use of systemic glucocorticoids,
  • Use of megestrol acetate or other appetite stimulants,
  • Use of general anorexigenic or weight-reducing agents, or
  • Use of androgens, other than testosterone replacement therapy for male hypogonadism at physiological doses and on a stable regimen for at least 6 months prior to randomization.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00267527
GH100-013
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ConjuChem
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ConjuChem
October 2006

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