Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT02012556
Eligibility Criteria:
Main Inclusion Criteria:
* Male or female, smoker or non-smoker, ≥18 and ≤65 years of age.
* HIV-positive with CD4 cell counts \>100 cells/mm3 and viral load \<10 000 copies/mL.
* On stable antiretroviral therapy (ART) regimen for at least 8 weeks prior to the first study drug administration.
* Body mass index (BMI) ≥ 20.0 kg/m2.
Main Exclusion Criteria:
* Opportunistic infection or HIV-related disease within 3 months prior to study drug administration.
* History of malignancy of any organ or tissue (with the exception of basal cell carcinoma of the skin, in situ carcinoma of the cervix and stable Kaposi not having required treatment for the past 6 months).
* For male subjects, suspicion of prostate cancer.
* For female subjects, history of breast cancer or strong family history (first degree relative) of breast cancer.
* Known hypopituitarism, history of pituitary tumor/surgery, head irradiation or severe head trauma that had affected the somatotropic axis.
* Use of any experimental or marketed GH or GRF/GHRH products, GH secretagogues, IGF-1, or insulin-like growth factor binding protein-3 (IGFBP-3) within 6 months prior to study drug administration and throughout the study.
* Positive pregnancy test at screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02012556
Study Brief:
Protocol Section:
NCT02012556