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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT03399903
Eligibility Criteria:
Inclusion Criteria:
* Age at least 18
* On ART for at least 1 year during which: viremia \<50 RNA copies/ml for at least 3 measurements (allowing for 1 nonconsecutive blip of \<100), and CD4 T cell count consistently \>500 during that time
* CD4 T cell nadir \>350
* Last CD4 and T cell test in past 6 months
Exclusion Criteria:
* Plans to modify antiretroviral therapy in the next 12 weeks for any reason
* History of inflammatory bowel disease or irritable bowel disease
* Chronic active hepatitis B or C
* History of autoimmune disease
* Hypersensitivity to any component of Pentasa
* Clostridium difficile infection
* Receiving rectally delivered medications
* Receiving anti-inflammatory medications (such as nonsteroidal anti- inflammatory drugs, steroids, or TNF inhibitors)
* Receiving immunosuppressive steroids
* Receiving any medications associated with bleeding risk
* Hemoglobin \< 10.0 g/dL
* Platelet count less than 100,000/mm3
* White blood cell count \< 2,000 cells/mm3 or \> 15,000 cells/mm3
* Symptoms of sexually transmitted infection
* Antibiotics used in the last 90 days
* Renal insufficiency with creatinine clearance less than 50 ml/min
* Elevated transaminases greater than 2.5 times the upper limit of normal
* Evidence of decompensated cirrhosis, heart failure
* Pregnant or breastfeeding women
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03399903
Study Brief:
Protocol Section:
NCT03399903