Patients 18 to 65 years old with HIV-associated visceral obesity, on a stable antiviral regimen for at least 6 weeks, with a viral load =1,000 copies/mL and CD4 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 waist circumference of =90 cm in men or =85 cm in women.
Conditions
Interventions
Product Name: CJC-1295
Product Code: CJC-1295
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: CJC-1295
Other descriptive name: CJC-1295 TFA salt
Concentration unit: mg mil
Sponsors
ConjuChem, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess and compare the efficacy, pharmacokinetics, safety, and tolerability of CJC-1295 in patients with human immunodeficiency virus (HIV)-associated visceral obesity.;Secondary Objective: ;Primary end point(s): Primary Efficacy Endpoint The primary efficacy endpoint is a percent change or absolute change in total IGF-1 levels from baseline comparing active and placebo-treated patients after 12 weeks of treatment. | — |
Countries
Germany
Outcome results
None listed