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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT03572335
Eligibility Criteria:
Inclusion Criteria:
1. Men and women age 18 to 80
2. HIV positive and participated in previous HLRC(HIV Lung Research Center) study (PRO10060177, PRO09050521, PRO14070355, PRO08030011, PRO00606151, PRO13050229, PRO17060077).
3. Negative pregnancy test (for women of child barring capabilities).
4. Have undergone bronchoscopy with BAL(bronchial lavage) and/or brushing for AECs in storage.
5. Receiving ART (Anti-Retroviral Therapy)and virally-suppressed for at least 6 months.
Exclusion Criteria:
1. Pregnancy or breast-feeding. (urine pregnancy done on all females of child bearing potential-males and females who are at least 1 year post menopausal or surgically sterile will not be tested)
2. Contraindication to pulmonary function testing (i.e. abdominal or cataract surgery within 3 months, recent myocardial infarction, etc.).
3. Increasing respiratory symptoms or febrile (temperature \>100.40F \[380C\]) within 4 weeks of study entry.
4. Acute cardiopulmonary issue in the past 4 months.
5. Uncontrolled hypertension at screening visit (systolic \> 180 mm Hg or diastolic \> 100 mm Hg) from an average of two or more readings. Subject may return for screening after blood pressure is controlled.
6. Active cancer requiring systemic chemotherapy or radiation.
7. Active infection of lungs, brain, or abdomen.
8. Intravenous drug use or alcohol use that will impair ability to complete study investigations in the opinion of the investigator.
9. subjects with an upper or lower respiratory tract infection
10. individuals receiving chronic or acute antibiotics in the prior 4 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03572335
Study Brief:
Protocol Section:
NCT03572335