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

ConjuChem

Status and phase

Terminated

Phase 2

Conditions

Obesity

HIV Infections

Treatments

Drug: CJC 1295

Study type

Interventional

Funder types

Industry

Identifiers

NCT00267527

GH100-013

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.