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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00661960
Eligibility Criteria:
Inclusion Criteria:
* willing to sign consent form
* no known GI pathology
* no anticipated antiretroviral therapy adjustments or changes
* males \& females between the ages of 18 \& 50 years
* no active opportunistic infections (OI) or therapy for OI within 30 days of entry
* can be on secondary prophylaxis with a history of AIDS defining illness
* per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study
Exclusion Criteria:
* abnormal coagulation parameters (PT \> or equal to 1.2 ULN)
* thrombocytopenia (platelet count \< 50,000 within 6 weeks)
* contra-indications to upper endoscopy or conscious sedation
* anemia (\> or equal to grade 1)
* aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00661960
Study Brief:
Protocol Section:
NCT00661960