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Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Philip Diaz, The Ohio State University.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: January 16, 2009
Last Update Posted: April 22, 2015
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. Read our disclaimer for details.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
January 15, 2009
January 16, 2009
April 22, 2015
March 2006
December 2015   (Final data collection date for primary outcome measure)
examine the natural history of smoking related lung damage in patients with HIV [ Time Frame: 3 years ]
HIV-Seropositive individuals are at increased risk of developing pulmonary emphysema (1,2). With improved therapy for HIV, and increased life expectancy in this population with a high smoking prevalence, chronic obstructive pulmonary disease (COPD) may assume an increasingly important role with respect to health related quality of life and medical complications. This research will provide a unique opportunity to examine the natural history of smoking related lung damage in patients with HIV infection. In addition, this research will involve sampling of lung cells to determine if there are unique proteins present that may be related to the increased risk of emphysema in this population. This may shed important insight into how the lung responds to injury and how it repairs itself. If critical proteins can be identified, treatment strategies may eventually be developed to either decrease proteins causing injury or increase protective proteins.
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Complete list of historical versions of study NCT00823927 on ClinicalTrials.gov Archive Site
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Alveolar Macrophage Proteomics in HIV-associated Emphysema
Alveolar Macrophage Proteomics in HIV-associated Emphysema
This study is being done to examine lung function changes in individuals with HIV infection and to understand why individuals with HIV have increased risk of lung damage from cigarette smoking.

To delineate the natural history of HIV associated emphysema in the HAART era. To compare the alveolar macrophage proteomes from HIV-seropositive smokers with emphysema to the alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.

To establish whether coinfection with HIV and Hepatitis C results in accelerated lung disease manifested by decrements in forced expiratory volume and carbon monoxide diffusing capacity.

Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples With DNA
blood lung fluid (optional)
Non-Probability Sample
community sample
  • HIV
  • Emphysema
  • HIV Infections
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  • 1
    HIV smokers with emphysema
  • 2
    HIV smokers without emphysema
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically stable HIV-seropositive (and HIV-seronegative) individuals
  • Ages 18 years and older
  • Female subjects on no oral contraception with a negative pregnancy test
  • Subjects capable of giving written consent

Exclusion Criteria:

  • Known medical illness that would preclude bronchoscopy/BAL (e.g. unstable angina, new cardiac arrhythmia). This only pertains to subjects involved in the bronchoscopy phase of the study.
  • Pregnant females
  • Prisoners
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Philip Diaz, The Ohio State University
Philip Diaz
National Institutes of Health (NIH)
Principal Investigator: Philip T Diaz, MD Ohio State University
Ohio State University
April 2015