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
- Conditions
- Patients 18 to 65 years old with HIV-associated visceral obesity, on a stableantiviral regimen for at least 6 weeks, with a viral load =1,000 copies/mL andCD4 count =200 cells/mm3, a body mass index (BMI) of =24 and =30 kg/m2,a waist-to-hip ratio of =0.95 in men or =0.90 in women, and a waistcircumference of =90 cm in men or =85 cm in women.
- Registration Number
- EUCTR2005-003797-25-DE
- Lead Sponsor
- ConjuChem, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
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
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
designee.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess and compare the efficacy, pharmacokinetics, safety, and tolerability<br>of CJC-1295 in patients with human immunodeficiency virus (HIV)-associated visceral obesity.;Secondary Objective: ;Primary end point(s): Primary Efficacy Endpoint<br><br>The primary efficacy endpoint is a percent change or absolute change in total IGF-1<br>levels from baseline comparing active and placebo-treated patients after 12 weeks of treatment. <br>
- Secondary Outcome Measures
Name Time Method