Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    cjc 1295 ...
  • Study Participants

    120
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 Started
Dec 31
2005
Study Completion
Sep 30
2006
Last Update
Oct 16
2006
Estimate

Drug CJC 1295

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.
No Results Posted