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

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ClinicalTrials.gov Identifier: NCT00267527
Recruitment Status : Terminated
First Posted : December 21, 2005
Last Update Posted : October 16, 2006
Sponsor:
Information provided by:
ConjuChem

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity HIV Infections Drug: CJC 1295 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2005
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: CJC-1295

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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ClinicalTrials.gov Identifier: NCT00267527    
Other Study ID Numbers: GH100-013
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: October 16, 2006
Last Verified: October 2006
Keywords provided by ConjuChem:
Treatment Experienced
HIV Visceral Obesity
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overnutrition
 Nutrition Disorders
Overweight
Body Weight