HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

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:
NCT02056158
First received: February 4, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

February 4, 2014
February 4, 2014
December 2013
August 2018   (final data collection date for primary outcome measure)
Changes in oxidant stress in the lower respiratory tract in association with HIV infection and smoking [ Time Frame: One year ] [ Designated as safety issue: No ]
Using samples obtained from subjects the extent and nature of the HIV/smoking-induced oxidant burden of the lower respiratory tract will be assessed.
Same as current
No Changes Posted
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HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium
HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

In HIV+ cigarette smokers, with no prior history of pulmonary infections, emphysema is often developed at an earlier age and is a significant cause of morbidity despite treatment with antiretroviral drugs. Preliminary data gathered from HIV+ individuals that smoke cigarettes strongly support the hypothesis that the combination of HIV infection and smoking creates increased stress in the lower respiratory tract. To examine the underlying factors that contribute to the accelerated development of emphysema in this cohort, samples from the lower respiratory tract will be provided by HIV+ and HIV- subjects. The samples collected will serve as biomarkers for assessing the onset of emphysema.

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Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

New York Metropolitan area residents

  • HIV
  • COPD
  • Emphysema
  • Smoking
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Negative Early COPD Smokers
    HIV Negative Early COPD Smokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Negative COPD Smokers
    HIV Negative COPD Smokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Negative Nonsmokers
    HIV Negative Nonsmokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Negative Smokers
    HIV Negative Smokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Positive Smokers
    HIV Positive Smokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Positive Nonsmokers
    HIV Positive Nonsmokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Positive COPD Smokers
    HIV Positive COPD Smokers
    Intervention: Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
  • HIV Positive Early COPD Smokers
    HIV Positive Early COPD Smokers
    Intervention: Genetic: 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
480
August 2018
August 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
 
NCT02056158
1307014135
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