HIV-related Accelerated Aging of the Airway Epithelium

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01974219
First received: October 25, 2013
Last updated: February 4, 2014
Last verified: February 2014

October 25, 2013
February 4, 2014
April 2013
March 2018   (final data collection date for primary outcome measure)
Gene expression changes in airway epithelium [ Time Frame: One Year ] [ Designated as safety issue: No ]
We examine the pathogenesis of the accelerated development of COPD in smokers with HIV infection and the premature biologic aging of the small airway epithelium (SAE) mediated by the effects of direct HIV infection of the SAE and/or through the interaction of HIV-infected T cells and/or alveolar macrophages (AM) with the SAE, resulting in the disordered biology of the SAE that is central to the pathogenesis of COPD.
Same as current
Complete list of historical versions of study NCT01974219 on ClinicalTrials.gov Archive Site
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HIV-related Accelerated Aging of the Airway Epithelium
HIV-related Accelerated Aging of the Airway Epithelium

In cigarette smokers that are HIV+, one of the most common HIV-associated non-AIDS conditions is the accelerated development of chronic obstructive pulmonary disease (COPD), a disorder associated with significant morbidity and mortality. Based on the knowledge that COPD in smokers starts in the small airway epithelium, this study is focused on examining the hypothesis that the accelerated development of COPD associated with HIV infection results, in part, from an interaction of HIV directly on the small airway epithelium or through infection of cellular components of the immune system, with mediators released by these immune cells evoking premature biologic aging of the small airway epithelium. By identifying the early events in the pathogenesis of the HIV-associated accelerated COPD in smokers, we aim to identify biologic targets to which pharmacologic therapies could be addressed.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

New York Metropolitan area residents

  • HIV
  • COPD
  • Chronic Obstructive Pulmonary Disease
  • Smoking
Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • Healthy nonsmokers
    Healthy nonsmokers
    Intervention: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • Healthy smokers
    Healthy smokers
    Intervention: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • COPD smokers
    COPD smokers
    Intervention: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
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March 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

HEALTHY VOLUNTEER RESEARCH SUBJECTS

  • All study subjects should be able to provide informed consent
  • Males or females ages 18 years and older
  • Must provide HIV informed consent

VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE

  • Must provide informed consent
  • Males and females age 18 years and older
  • Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease
  • Must provide HIV informed consent

Exclusion Criteria:

HEALTHY VOLUNTEER RESEARCH SUBJECTS

  • Individuals not deemed in good overall health by the investigator will not be accepted into the study.
  • Habitual use of drugs and/or alcohol within the past six months (Acceptable: - Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria).
  • Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.
  • Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.
  • Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.
  • Females who are pregnant or nursing will not be accepted into the study

VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE

  • Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study.
  • Habitual use of drugs and/or alcohol within the past six months (Acceptable: Marijuana one time in three months; average of two alcoholic beverages per day; drug and/or alcohol abuse is defined as per the DSM-IV Substance Abuse Criteria)
  • Females who are pregnant or nursing
Both
18 Years and older
Yes
Contact: Charleen Hollman, PhD, MPA, RN 646-962-2672 chollman@med.cornell.edu
Contact: Mitch Greene, MA 646-962-2672 mig2037@med.cornell.edu
United States
 
NCT01974219
1306013986
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Ronald G Crystal, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP