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Clinical Trials/EUCTR2005-003797-25-DE
EUCTR2005-003797-25-DEActive, not recruitingNot Applicable

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

ConjuChem, Inc.0 sites150 target enrollmentStarted: September 7, 2005Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Able to provide written informed consent.
  • •2. Age 18 to 65 years.
  • •3. Documented HIV infection.
  • •4. HIV-associated visceral obesity as judged by the Investigator and meeting the
  • •following criteria:
  • •- Waist-to-hip ratio associated with increased risk for cardiovascular disease
  • •(=0.95 in men and =0.90 in women),
  • •- Waist circumference =90 cm in men and =85 cm in women, and
  • •- Body mass index (BMI) =24 or =30 kg/m2, calculated as described in
  • •Section 6.1.6.
  • •5. Viral load =1,000 copies/mL.
  • •6. CD4 count =200 cells/mm3.
  • •7. On a stable antiviral regimen for at least 6 weeks prior to randomization.
  • •8. Women with childbearing potential must provide a negative pregnancy test prior to randomization and must use an adequate, double-barrier contraceptive method.
  • •(Non-childbearing potential is defined as post-menopausal for at least 1 year or
  • •surgical sterilization or hysterectomy at least 3 months before study start).
  • •9. Ability to understand study requirements and willingness to follow instructions,
  • •attend all required study visits, and undergo all planned procedures (including SC
  • •injections in the abdominal wall and drawing of blood samples).
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Diabetes mellitus.
  • •2. Fasting triglyceride level =11.3 mmol/L (1,000 mg/dL).
  • •3. Unstable or untreated hypertension (>140/90 mmHg at screening).
  • •4. Active malignancies.
  • •5. BMI =24 or =30 kg/m2.
  • •6. Hemoglobin <9 g/dL.
  • •7. Use of GH or other GH secretagogues (except GHRH and GHRF, which may not
  • •have been used at all) within 3 months prior to randomization.
  • •8. Previous use of GHRH or GHRF.
  • •9. Use of (or anticipated need for) any of the following medications with 3 months prior to randomization:
  • •- systemic glucocorticoids,
  • •- megestrol acetate or other appetite stimulants,
  • •- general anorexigenic or weight-reducing agents, or
  • •- 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.
  • •10. History of carpal tunnel syndrome, unless resolved by surgical release.
  • •11. Pregnant and/or breast-feeding women, or women within 3 months post-partum.
  • •12. Hepatic transaminases >3 times the upper limit of normal (ULN).
  • •13. Treatment with any investigational drug within 30 days prior to randomization.
  • •14. Abnormal 12-lead ECG, which, in the opinion of the Investigator, is clinically
  • •significant.
  • •15. Significant abnormality of the CT-scan (e.g., suspicion of tumor) as determined by
  • •the investigator.
  • •16. Major illness within the past 4 weeks that is, in the opinion of the Investigator,
  • •clinically serious, unstable, and/or uncontrolled, or that would make the patient
  • •unsuitable for entry in the study.
  • •17. Major surgery within 3 months prior to randomization and/or any surgery within
  • •2 weeks of randomization, unless approved by the sponsor’s medical monitor or
  • •18. Donation of blood within 60 days of randomization.
  • •19. Dependence on or abuse of alcohol, narcotic, opioid, or other addictive substances.
  • •20. History of hypersensitivity to the study medication or to drugs with similar chemical structures.
  • •21. History or suspicion of unreliability, poor cooperation or non-compliance with
  • •medical treatment.
  • •22. Any concurrent disease or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
  • •23. Previous enrollment in this study.

Investigators

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