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
  Purpose

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.


Condition Intervention
HIV
COPD
Chronic Obstructive Pulmonary Disease
Smoking
Genetic: Examination of the interaction of HIV directly on the small airway epithelium

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: HIV-related Accelerated Aging of the Airway Epithelium

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 330
Study Start Date: April 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy nonsmokers
Healthy nonsmokers
Genetic: Examination of the interaction of HIV directly on the small airway epithelium
Healthy smokers
Healthy smokers
Genetic: Examination of the interaction of HIV directly on the small airway epithelium
COPD smokers
COPD smokers
Genetic: Examination of the interaction of HIV directly on the small airway epithelium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

New York Metropolitan area residents

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974219

Contacts
Contact: Charleen Hollman, PhD, MPA, RN 646-962-2672 chollman@med.cornell.edu
Contact: Mitch Greene, MA 646-962-2672 mig2037@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine Recruiting
New York, New York, United States, 10065
Contact: Charleen Hollmann, PhD, MPA, RN    646-962-2672    chollman@med.cornell.edu   
Contact: Mitch Greene, MA    646-962-2672    mig2037@med.cornell.edu   
Sub-Investigator: Robert Kaner, MD         
Sub-Investigator: Jason Mezey, PhD         
Sub-Investigator: Renat Shaykhiev, MD, PhD         
Sub-Investigator: Matthew Walters, PhD         
Sub-Investigator: Jenny Yee-Levin, PA         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Ronald G Crystal, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01974219     History of Changes
Other Study ID Numbers: 1306013986
Study First Received: October 25, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
HIV
COPD
Chronic Obstructive Pulmonary Disease
Smoking

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014