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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity HIV Infections

Keywords

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Treatment Experienced HIV Visceral Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CJC 1295

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Countries

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Canada

Other Identifiers

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GH100-013

Identifier Type: -

Identifier Source: org_study_id