A Study to Evaluate CJC 1295 in HIV Patients With Visceral Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00267527
• Other study ID #: GH100-013
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2005
• Last updated: October 12, 2006
• Start date: December 2005
• Est. completion date: September 2006

Study information

• Verified date: October 2006
• Source: ConjuChem
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Obesity

Intervention

Drug:
• CJC 1295

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ConjuChem