NCT02836067

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Counseling	Smoking cessation counseling
OTHER	Smoking Cessation drugs	Medication to aid smoking cessation
PROCEDURE	Bronchoscopy	Bronchoscopy
PROCEDURE	Blood Draw	Screening and research blood draws
BEHAVIORAL	Questionnaires	Behavioral questionnaires

Timeline

• Start date: 2017-06-15
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2016-07-18
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States