Impact of Smoking and Its Cessation on Systemic and Airway Immune Activation

Summary

Participation Requirements

Description

For Aim 1, 20 patients with HIV disease who have never smoked will be recruited with comparison to 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 referre...

For Aim 1, 20 patients with HIV disease who have never smoked will be recruited with comparison to 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 patients have similar inclusion/exclusion criteria as this study and have been verified to be HIV-antibody negative. We 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 20 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 20 subjects achieve successful smoking cessation. The maximum total number of patients needed for the grant is 120 (100 HIV smokers, 20 HIV non-smokers). We will recruit up to 120 patients from the BMC Center for Infectious Diseases (CID) outpatient clinic. The 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. We will recruit from flyers, the BMC ReSPECT registry, medical record screening, and physician referrals. A listing of the trial will also be posted on clinicaltrials.gov.

Tracking Information