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 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT02836067
Eligibility Criteria:
Inclusion criteria.
1. HIV infected on ART ≥ 6 months
2. Virologically suppressed (\<50 cop/ml) at the time of enrollment (lab test within 3 months )
3. Smoking Status:
Currently Active Smoker: Self-reported regular cigarette use with positive cotinine test at screening visit.
OR Non-smoker: self-reported non-smokers confirmed by negative cotinine test at screening visit.
4. Laboratory values within 3 months prior to enrollment that meet the following criteria:
1. Hemoglobin ≥ 8.0 g/dL
2. Platelet count ≥ 80,000/mm3
5. For females of child-bearing potential: Negative urine pregnancy test (sensitive to 25 IU HCG) at screening visit.
For purposes of this study, a female is considered of child-bearing potential unless:
* Permanently sterile (includes hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)
* Medically documented ovarian failure
* Post-menopausal, defined as ≥ 55 years of age with cessation of menses for ≥ 12 months
Exclusion criteria:
1. Pregnant or breast-feeding or less than 8 weeks post-partum.
2. Active malignancy and receiving concurrent treatment (i.e. chemotherapy, radiation therapy, investigational treatment).
3. Significant immunological illnesses/deficiencies
4. Recent active illness within the past 1 month (i.e. respiratory viral infection, pneumonia, bacterial infections, bone infection)
5. History of tuberculosis, lung cancer, bronchiectasis, pulmonary fibrosis, or pulmonary hypertension
6. Self-reported regular or recreational use of inhaled substances (such as marijuana, crack, fentanyl, heroin, hookah, e-cigarettes) as well as chewing tobacco within past month. Reports of no such use within the past month will be confirmed by a urine tox screen performed at the Screening Visit.
7. Self-reported regular use of inhaled substances (such as crack, fentanyl, heroin, hookah, e-cigarettes) in the past (prior to 1 month ago and within the past 5 years), with use occurring for \> 1 year. (Marijuana use is allowable.)
8. Spirometry criteria FEV1/FVC \< 0.7 (definition of COPD) and GOLD (severe-very severe) Stage 3 or 4 within past 12 months
9. A history of alcohol dependence within the 6 months prior to enrollment
10. History of intolerance, sensitivity, allergy or anaphylaxis to lidocaine or other amide anesthetics, as well as benzocaine or other ester type anesthetics
11. History of recent myocardial infarction (within past 6 months). Non-coronary ischemia MI is allowed (i.e. cocaine-induced)
12. Chronic renal failure requiring dialysis
13. Decompensated cirrhosis
14. Currently taking anticoagulants including but not limited to: heparin (Hep-Lock, Hep-Pak), Hep-Pak CVC, Heparin Lock Flush), warfarin (Coumadin), tinzaparin (Innohep), enoxaparin (Lovenox), danaparoid (Orgaran), dalteparin (Fragmin), clopidogrel (Plavix), prophylactic aspirin, and NSAID use and unable to stop for 48 hours prior to bronchoscopy
15. Taking any of the following medications within 30 days prior to enrollment: systemic steroids (inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (e.g., local injection of interferon alpha for treatment of HPV is permitted) or systemic chemotherapy, anti-TNF agents
16. Recent abdominal surgery (within past 3 months)
17. Recent eye surgery (within past 3 months)
18. Investigator discretion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02836067
Study Brief:
Protocol Section:
NCT02836067