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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
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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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Information from the National Library of Medicine

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

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.

ClinicalTrials.gov Identifier: NCT00267527     History of Changes
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:
HIV Infections
Obesity, Abdominal
Nutrition Disorders
Body Weight
Signs and Symptoms
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases