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临床试验/EUCTR2005-003797-25-DE
EUCTR2005-003797-25-DE进行中(未招募)不适用

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 个研究点目标入组 150 人开始时间: 2005年9月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 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

排除标准

  • 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.

研究者

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A Multicenter, Randomized, Placebo-controlled,... | 临床试验