Back to resultsA Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
Primary Purpose
Obesity, HIV Infections
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CJC 1295
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Treatment Experienced, HIV Visceral Obesity
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00267527
Brief Title
A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
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 Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
ConjuChem
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, HIV Infections
Keywords
Treatment Experienced, HIV Visceral Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CJC 1295
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity
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