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

This study is currently recruiting participants.
Verified August 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT02058719
First Posted: February 10, 2014
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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.


Condition
HIV Smoking COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunosuppressive Effects of Smoking and HIV-1 on the Development of Lung Disease.

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The change in immunoregulatory markers: PD-1 expression and interleukin (IL)-10 production by alveolar macrophages (AMs) from baseline to week 24. [ Time Frame: Baseline, Week 24 ]
    Evaluate the immunoregulatory change between HIV positive (smokers/non-smokers) and HIV negative (smokers/non-smokers)

  • PD-1 expression and IL-10 production by AMs at baseline [ Time Frame: Baseline ]
    Evaluate the association of PD-1 expression and IL-10 production by AMs after long-term antiretroviral therapy (ART) with abnormal lung function and a COPD phenotype between HIV positive (with and without COPD) and HIV negative with COPD.


Biospecimen Retention:   Samples Without DNA
Blood and bronchoscopy (BAL) samples will be collected

Estimated Enrollment: 210
Actual Study Start Date: March 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cohort A1
HIV positive smokers
Cohort A2
HIV positive non-smokers
Cohort A3
HIV negative smokers
Cohort A4
HIV negative non-smokers
Cohort B1
HIV positive with COPD
Cohort B2
HIV positive without COPD (non-COPD)
Cohort B3
HIV negative with COPD

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
HIV positive (smokers and non-smokers) and negative subjects (smokers and non-smokers) will be recruited. HIV positive (with and without COPD) and HIV negative with COPD will also be recruited. All subjects will be between ages 18 and 70.
Criteria

Inclusion Criteria (Cohort A):

  • 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)

Inclusion Criteria (Cohort B):

  • 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 (Cohort A and B):

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058719


Contacts
Contact: Thomas B. Campbell, MD 303-724-4929 thomas.campbell@ucdenver.edu
Contact: Christine Griesmer, RN 303-724-0762 christine.griesmer@ucdenver.edu

Locations
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Thomas B. Campbell, MD    303-724-4929    thomas.campbell@ucdenver.edu   
Principal Investigator: Thomas B. Campbell, MD         
Principal Investigator: Andrew Fontenot, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Thomas B. Campbell, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02058719     History of Changes
Other Study ID Numbers: 13-2986
First Submitted: February 5, 2014
First Posted: February 10, 2014
Last Update Posted: August 31, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs