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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01744093
Eligibility Criteria:
Inclusion Criteria:
1. Documented HIV infection
2. CD4 cell count greater than 200 cells/mm3
3. HIV RNA less than 400 copies/ml
4. Stable antiretroviral therapy for greater than or equal to 12 weeks
5. Fulfills GOLD definition for COPD (post-bronchodilator FEV1/FVC less than 0.7) and/or has radiographic evidence of emphysema
6. Current or history of smoking with minimum 3 pack-year history
7. ALT and AST less than 3 x upper limit of normal
8. For women of childbearing potential: willingness to use 2 forms of birth control
9. Subjects on therapy for COPD must be on stable therapy for at least 4 weeks
Exclusion Criteria:
1. Pulmonary infection, COPD exacerbation, or acute opportunistic infection within 30 days of entry
2. Conditions associated with increased sedation of bronchoscopy risk, including but not limited to Gold class 3 or 4 COPD, requirement for home oxygen, hypercapneic respiratory failure, poorly controlled hypertension
3. Known allergy/intolerance to doxycycline, atropine, or any local anesthetic
4. Inability to provide informed consent
5. Pregnant or lactating women
6. Men must agree not to attempt to make a woman pregnant or participate in sperm donation during the study and for 6 weeks after discontinuing the drug
7. End stage renal disease
8. Cirrhosis
9. INR greater than 1.4
10. Platelets less than 80,000
11. Any condition including active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or increase the risk of bronchoscopy
12. Active or planned participation in any other clinical trial or observational study without prior approval from the PI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT01744093
Study Brief:
Protocol Section:
NCT01744093