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Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease

NCT ID: NCT02058719

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2019-12-31

Brief Summary

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This study plans to learn more about pulmonary complications of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS). Even though antiretroviral therapy (ART) has dramatically decreased the number of opportunistic infections and deaths in HIV infected patients, pulmonary complications (including chronic obstructive pulmonary disease (COPD) development and pneumonias resulting in decreased lung function) of HIV/AIDS continue to be a major cause of morbidity and mortality in this population. The mechanisms underlying the increased risk of COPD and decreased lung function in HIV infected individuals is not well understand and needs to be studied.

The investigators hypothesize that the immunoregulatory consequences and immunosuppressive lung milieu secondary to HIV and cigarette smoke combine to increase the risk of lung infection and injury in HIV infected smokers, hastening the development of COPD. The mechanisms will be directly tested using blood and bronchial alveolar lavage (BAL) cells from smokers and nonsmokers with and without HIV infection.

Detailed Description

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The first component of this study will be a longitudinal, prospective, 24 weeks study of the effects of HIV-1 infection on innate and acquired immunity in the lung (Cohort A). The second component of this study will be a cross-sectional, case-control study of lung function and immune dysregulation of HIV-1 infected persons on long-term ART (Cohort B).

Cohort A will consist of 120 subjects, stratified by HIV-1 and smoking status

Cohort B will consist of 90 subjects stratified by chronic obstructive pulmonary disease (COPD) and HIV-1 infection.

Conditions

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HIV Smoking COPD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A1

HIV positive smokers

No interventions assigned to this group

Cohort A2

HIV positive non-smokers

No interventions assigned to this group

Cohort A3

HIV negative smokers

No interventions assigned to this group

Cohort A4

HIV negative non-smokers

No interventions assigned to this group

Cohort B1

HIV positive with COPD

No interventions assigned to this group

Cohort B2

HIV positive without COPD (non-COPD)

No interventions assigned to this group

Cohort B3

HIV negative with COPD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic HIV-1 infection (Cohorts A1 and A2)
* ART naïve or off all ART for \>6 months (Cohorts A1 and A2)
* HIV-1 RNA level \>1,000 copies/ml (Cohorts A1 and A2)
* HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohorts A3 and A4)
* 18 years and older (All Cohort A)
* Active cigarette smoker (Cohorts A1 and A3)


* Age from 30 to 70 years
* Subjects with chronic HIV-1 infection (Cohorts B1 and B2)
* Subjects on stable 3-drug ART regimen with plasma HIV-1 RNA \<50 copies/mL for past 6 months (Cohorts B1 and B2)
* HIV-1 seronegative with no high-risk exposure in the past 30 days (Cohort B3) COPD: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) \<70% and forced expiratory volume (FEV), 45-100% of predicted (Cohort B1 and B3)
* Non-COPD: FEV/FVC \>70% and an FEV, \>80% of predicted (Cohort B2)

Exclusion Criteria

* Pregnancy
* Weight less than 110 pounds (for venipuncture)
* Patient inability to participate in the study and undergo venipuncture and bronchoscopy procedures
* Use of systemic or inhaled corticosteroids in the past 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas B. Campbell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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13-2986

Identifier Type: -

Identifier Source: org_study_id