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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
  Purpose

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.


Condition Intervention
HIV
COPD
Emphysema
Smoking
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: HIV+ Alveolar Macrophage Oxidant-mediated Apoptosis of Pulmonary Endothelium

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 480
Study Start Date: December 2013
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HIV Negative Early COPD Smokers
HIV Negative Early COPD Smokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Negative COPD Smokers
HIV Negative COPD Smokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Negative Nonsmokers
HIV Negative Nonsmokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Negative Smokers
HIV Negative Smokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Positive Smokers
HIV Positive Smokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Positive Nonsmokers
HIV Positive Nonsmokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Positive COPD Smokers
HIV Positive COPD Smokers
Genetic: Genetic: Examination of the interaction of HIV directly on the small airway epithelium
HIV Positive Early COPD Smokers
HIV Positive Early COPD Smokers
Genetic: 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: NCT02056158

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: Steven Gross, Phd         
Sub-Investigator: Robert Kaner, MD         
Sub-Investigator: Jason Mezey, PhD         
Sub-Investigator: Ruba Deeb, PhD         
Sub-Investigator: Matthew Walters, PhD         
Sub-Investigator: Mitch Greene, MA         
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: NCT02056158     History of Changes
Other Study ID Numbers: 1307014135
Study First Received: February 4, 2014
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
HIV
COPD
Emphysema
Smoking

Additional relevant MeSH terms:
Emphysema
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014