University of Colorado, Denver – COPD: Inclusion/Exclusion Criteria

Inclusion Criteria (Cohorts A1-A4)
HIV+ subjects not currently on ART, but with plan to initiate

• Subjects with chronic HIV-1 Infection defined as a positive ELISA confirmed by a positive Western Blot or plasma HIV-1 RNA level >1,000 copies/mL at any time in the past (Cohorts A1 and A2)
• ART naïve or off all ART for >6 months and intending to start or reinitiate ART (Cohorts A1 and A2)
• HIV-1 RNA level > 1,000 copies/ml at any time in the past (Cohorts A1 and A2)
• HIV-1 seronegative with no high-risk HIV-1 exposure in the prior 30 days (Cohorts A3 and A4)
• 18 years and older (Cohorts A1-A4)
• Active cigarette smokers defined as an average cigarette use of one half pack per day for the past six months (Cohorts A1 and A3)

Inclusion Criteria (Cohorts B1-B3)

• Age from 40 to 70 years
• Subjects with chronic HIV-1 infection defined as a positive ELISA confirmed by a positive Western Blot or plasma HIV-1 RNA level >1,000 copies/mL at any time in the past (Cohorts B1 and B2)
• Subjects on a stable three-drug ART regimen for greater than 3 years (Cohorts B1 and B2)
• Plasma HIV-1 RNA <50 copies/mL (Cohorts B1 and B2)
• HIV-1 seronegative with no high-risk HIV-1 exposure in the prior 30 days (Cohort B3)
• COPD: FEV1/FVC <70% and FEV1 45-100% of predicted (Cohorts B1 and B3)
• Non-COPD: FEV1/FVC ≥70% and an FEV1 >80% of predicted (Cohort B2)

Exclusion Criteria (Cohorts A and B)

• Pregnancy
• Weight less than 110 lbs. (for venipuncture)
• Patient inability to participate in the study, such as inability to undergo venipuncture and bronchoscopy procedures that form part of the inclusion/exclusion criteria or part of the outcome measure
• Use of systemic or inhaled corticosteroids in the past 3 months