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

ConjuChem0 sites120 target enrollmentDecember 2005

ConditionsObesity HIV Infections

DrugsCJC 1295

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Obesity
Sponsor: ConjuChem
Enrollment: 120
Status: Terminated
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

September 2006

Last Updated

19 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ConjuChem

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

•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.