Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00823927
First received: January 15, 2009
Last updated: April 20, 2015
Last verified: April 2015

January 15, 2009
April 20, 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 ] [ Designated as safety issue: Yes ]
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
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood lung fluid (optional)

Non-Probability Sample

community sample

  • HIV
  • Emphysema
  • HIV Infections
Not Provided
  • 1
    HIV smokers with emphysema
  • 2
    HIV smokers without emphysema
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
365
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823927
2005H0197
Yes
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

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