Weill Medical College of Cornell University: Inclusion/Exclusion Criteria

Inclusion Criteria for Healthy, HIV- Nonsmokers

• Males and females, age 18 or older
• Must be capable of providing informed consent
• Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine <2ng/ml and cotinine <5 ng/ml)
• Normal physical examination
• Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• Not taking any medications relevant to lung disease or having an effect on the airway epithelium
• Negative HIV serology
• Normal chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in study

Exclusion Criteria for Healthy, HIV- Nonsmokers

• Unable to meet the inclusion criteria
• Current active infection or acute illness of any kind
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for Healthy, HIV- Smokers

• Males or females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• Negative HIV serology
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in study

Exclusion Criteria for Healthy, HIV- Smokers

• Unable to meet the inclusion criteria
• Current active infection or acute illness of any kind
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria Early COPD HIV- Smokers

• Males and females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Normal spirometry, normal TLC, but low DLCO as evidence of early COPD
• Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• Negative HIV serology
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study

Exclusion Criteria Early COPD HIV- Smokers

• Unable to meet the inclusion criteria
• Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• Current active infection or acute illness of any kind
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for COPD HIV- Smokers

• Males and females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Meeting GOLD stages I-II criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry
• Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• Negative HIV serology
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study

Exclusion Criteria for COPD HIV- Smokers

• Unable to meet the inclusion criteria
• Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• Current active infection or acute illness of any kind
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for Healthy, HIV+ Nonsmokers

• Males or females, age 18 or older
• Must be capable of providing informed consent
• Self-reported never-smokers, with current smoking status validated by the absence of nicotine metabolites in urine (nicotine <2ng/mL and cotinine <5ng/mL)
• Normal physical examination
• Good overall health without history of chronic lung disease, including asthma, and without recurrent or recent (within 3 months) acute pulmonary disease
• Normal chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study
• Documented HIV infection (positive HIV 1 antibody ELISA with Western analysis confirmation)

Exclusion Criteria for Healthy, HIV+ Nonsmokers

• Unable to meet the inclusion criteria
• Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for Healthy, HIV+ Smokers

• Males or females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study
• Documented HIV infection (positive HIV 1 antibody ELISA with Western analysis confirmation)

Exclusion Criteria for Healthy, HIV+ Smokers

• Unable to meet the inclusion criteria
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for Early COPD HIV+ Smokers

• Males or females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Normal spirometry, normal TLC, but low DLCO as evidence of early COPD
• Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study
• Documented HIV infection (positive HIV 1 antibody ELISA with Western analysis confirmation)

Exclusion Criteria for Early COPD HIV+ Smokers

• Unable to meet the inclusion criteria
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy

Inclusion Criteria for COPD HIV+ Smokers

• Males or females, age 18 or older
• Must be capable of providing informed consent
• Self-reported current daily smokers with >10 pack-yr, validated by any of the following: urine nicotine >30ng/ml or urine cotinine >50ng/ml
• Meeting GOLD stages I-II criteria for chronic obstructive lung disease (COPD) based on postbronchodilator spirometry
• Taking any or no pulmonary-related medication, including beta-agonists, anticholinergics, or inhaled corticosteroids
• Normal routine laboratory evaluation, including general hematologic studies, general serologic/immunologic studies, general biochemical analyses, and urine analysis
• All individuals have chest X-ray (PA and lateral) and chest HRCT
• Normal electrocardiogram (sinus bradycardia, premature atrial contractions are permissible)
• Females – not pregnant
• No history of allergies to medications to be used in the bronchoscopy procedure
• Willingness to participate in the study
• Documented HIV infection (positive HIV 1 antibody ELISA with Western analysis confirmation)

Exclusion Criteria for COPD HIV+ Smokers

• Exclusion criteria for COPD HIV+ Smokers:
• Unable to meet the inclusion criteria
• Evidence of malignancy within the past 5 years
• Current alcohol or drug abuse
• Pregnancy