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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03826160
Eligibility Criteria:
Inclusion Criteria:
* Men and women, ages 40-70 years
* Documented HIV infection on stable antiretroviral therapy for ≥ 3 months
* Abdominal obesity with waist circumference ≥ 102 cm in men, ≥ 88 cm in women
* Indication for tesamorelin per clinical judgment
Exclusion Criteria:
* CD4 \< 100 cells/mm3 or HIV viral load \> 400 copies/mL
* Current active AIDS-defining illness
* History or symptoms consistent with heart failure
* Standard contraindications to MRI including severe allergy to gadolinium
* Glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2 within one month of MRI study
* Use of growth hormone-releasing hormone (GHRH) or growth hormone (GH) within the past 6 months
* HbA1c \> 7%, chronic insulin use within the past 6 months, and/or change in anti-diabetic agents within the past 3 months
* Change in statin therapy within the past 3 months
* Chronic corticosteroid use except intermittent topic steroid creams or inhalers
* Pregnancy or breastfeeding
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03826160
Study Brief:
Protocol Section:
NCT03826160