Impact of Smoking and Its Cessation on Systemic and Airway Immune Activation
Condition: HIV; Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to learn how smoking affects the immune systems in people with
      HIV infection. The investigators would like to know if HIV infected smokers who quit smoking
      have different responses in their tissues from people who keep smoking.
    

Detailed description: 
      For Aim 1, a total of up to 30 patients with HIV disease who have never smoked will be
      recruited, with recruitment stopping before 30 samples if the samples from 20 patients that
      can be used in analysis have been obtained. These 20 non-smoker samples will be compared to
      those of 20 active smokers with HIV disease, without evidence of COPD from spirometry, who
      are matched in demographics. Smokers who are interested in participating in a smoking
      cessation program will be referred to our Clinical Trials Unit (CTU) for all subsequent study
      visits.

      Additionally, a comparison group of 20 uninfected smokers who have already been enrolled in
      the co-investigator's (Dr. Kwon) study will be used as comparison group. These participants
      have similar inclusion/exclusion criteria as this study and have been verified to be
      HIV-antibody negative. The investigators will obtain de-identified samples and immunological
      and virological data already collected by Dr. Kwon. De-identified banked PBMC, plasma and BAL
      samples will also be accessible to us using a material transfer agreement to perform
      epithelial transcriptional gene expression profiling.

      For Aim 2, a total of 100 HIV-infected individuals on effective ART who are active smokers
      and interested in participating in a smoking cessation program will be recruited. If 30
      individuals who achieve 10-week of cessation are enrolled before 100 HIV smokers are fully
      enrolled, enrollment will cease, as 100 participants is an overestimate of the number of
      patients needed need to enroll to have 30 subjects achieve successful smoking cessation. Just
      like for nonsmokers, recruitment for both smoker cohorts will stop before 30 if samples from
      20 patients that can be used in analysis have been obtained. The maximum total number of
      patients needed for the grant is 130 (100 HIV smokers, 30 HIV non-smokers).

      About130 participants will be recruited from the BMC Center for Infectious Diseases (CID)
      outpatient clinic, other outpatient clinics within BMC, affiliated community health centers
      (CHCs), BWH, MGH, Tufts Medical Center, and Beth Israel Deaconess Medical Center. The BMC CID
      clinic serves the largest HIV-infected population in Boston, approximately 1,700 persons, and
      is composed largely of an urban socioeconomically disadvantaged population. Over 50% of
      HIV-infected patients in the CID are smokers, and >60% (based on prescription history of NRT,
      bupropion, varenicline) have attempted smoking cessation. Participants will be recruited from
      flyers, the BMC ReSPECT registry, medical record screening, and physician referrals.
    

Intervention name(s): Counseling; Smoking Cessation drugs; Bronchoscopy; Blood Draw; Questionnaires
Intervention type(s): Behavioral; Other; Procedure; Procedure; Behavioral
Intervention description(s): Smoking cessation counseling; Medication to aid smoking cessation; Bronchoscopy; Screening and research blood draws; Behavioral questionnaires
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science