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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT06843902
Eligibility Criteria:
Inclusion Criteria:
* female sex-at-birth
* self-report of HIV on stable antiretroviral therapy ≥180 days
* age 45 -75 years
* at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine albumin to creatinine ratio \>30 mg/g
* coronary flow reserve \<2.5 or stress myocardial blood flow \<2.5 on screening cardiac positron emission tomography/computed tomography
Exclusion Criteria:
* current SGLT2 inhibitor use
* known allergy to SGLT2 inhibitor use
* type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)
* self-reported history of polycystic kidney disease
* self-reported history of myocardial infarction, stroke, or coronary revascularization
* stable or unstable angina
* self-reported history of heart failure
* hemoglobin A1c ≥8.5% at screen
* uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg
* estimated glomerular filtration rate \<30 ml/min/1.73 m2
* currently receiving hemodialysis or peritoneal dialysis
* CD4 \<400 cell/mm3
* current treatment with systemic (oral, IV, IM or intra-articular) steroids or anti-inflammatory/immune suppressant therapies (excluding topical therapies, UV therapy, ASA-derivatives, or NSAIDs) for any indication, including kidney disease
* pregnancy or breastfeeding
* known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine
* concurrent enrollment in conflicting research study
* self-reported history of recurrent urinary tract-infections (≥2 urinary tract infections within 6 months or ≥3 within a year) and/or recurrent vaginal yeast infections (≥2 vaginal yeast infections within 6 months or ≥3 within a year)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT06843902
Study Brief:
Protocol Section:
NCT06843902