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

This study has been terminated.
Sponsor:
Information provided by:
ConjuChem
ClinicalTrials.gov Identifier:
NCT00267527
First received: December 20, 2005
Last updated: October 12, 2006
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
HIV Infections
 Drug: CJC 1295
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Obesity
U.S. FDA Resources

Further study details as provided by ConjuChem:

Estimated Enrollment: 120
Study Start Date: December 2005
Estimated Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00267527     History of Changes
Other Study ID Numbers: GH100-013
Study First Received: December 20, 2005
Last Updated: October 12, 2006
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by ConjuChem:
Treatment Experienced
HIV Visceral Obesity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Obesity
Obesity, Abdominal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013