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
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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