NCT00267527

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2 obesity

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_2 obesity

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

October 16, 2006

Status Verified

October 1, 2006

First QC Date

December 20, 2005

Last Update Submit

October 12, 2006

Conditions

ObesityHIV Infections

Keywords

Treatment ExperiencedHIV Visceral Obesity

Interventions

CJC 1295DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 on stable antiviral regimen
  • Documented HIV infection
  • HIV associated visceral obesity
  • Body mass index (BMI) \> 24 and \< 30 kg/m2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityHIV Infections

Interventions

CJC 1295

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

December 1, 2005

Study Completion

September 1, 2006

Last Updated

October 16, 2006

Record last verified: 2006-10