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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT01869634
Eligibility Criteria:
Inclusion Criteria:
* Willing to sign consent form
* Naïve to ART (remote ART use \>5 years will be considered on a case by case basis)
* No known GI or cardiovascular disease
* Between the ages of 18 and 60
* No active opportunistic infections or therapy for acute OI within 30 days of entry. Subjects can be on secondary prophylaxis with a history of AIDS defining illness.
* All women of childbearing potential (WCBP) must have a negative urine pregnancy test before any of the invasive or radiation exposure study procedures.
* Normal population should be free of chronic metabolic conditions such as diabetes, hypercholesterolemia, or coronary artery disease
* There are no CD4+ T-cell count or HIV plasma viral load restrictions.
Exclusion Criteria:
* Abnormal coagulation parameters (PT\>1.2 upper limit of normal (ULN))
* Thrombocytopenia (platelet count \<50.000 within 6 weeks)
* Contra-indications to upper endoscopy or conscious sedation
* Anemia (\>grade 1 \[appendix 1\])
* Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy.
* Renal insufficiency (serum Creatinine \>1.2 ULN)
* History of chronic proteinuria that could impact viread use.
* Allergy to contrast used for CT angiography
* Requirement to take medications that are contraindicated with study ART regimen.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01869634
Study Brief:
Protocol Section:
NCT01869634