- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00267527
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GH100-013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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