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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02264860
Eligibility Criteria:
Inclusion Criteria:
* Subjects living with HIV-1 infection who have been on anti-retroviral therapy (ART) for a minimum of 18 months and are followed longitudinally for their HIV healthcare in one of the study sites in Atlanta.
* Ability to give informed consent.
Exclusion Criteria:
* Documented history of cirrhosis or a direct bilirubin ≥ 2.0 mg/ld.
* Documentation of left ventricular ejection fraction \< 40% or myocardial infarction within the past 6 months.
* End-stage renal disease requiring dialysis or a serum creatinine ≥ 2 mg/dL.
* Spirometry with Forced vital capacity (FVC) or Forced expiratory volume in 1 second (FEV1) \< 70% of predicted value.
* Diabetes
* Known or possible pregnancy or attempting to become pregnant or breastfeeding
* BMI \< 17
* Age \< 21
* Parkinson's disease: these are all b/c the SAMe risks sections states that these pts will not qualify
* Bipolar disorder
* Bleeding disorders such as thrombocytopenia or significant gastrointestinal bleeding within the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02264860
Study Brief:
Protocol Section:
NCT02264860