Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)

This study is ongoing, but not recruiting participants.
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University Identifier:
First received: January 15, 2009
Last updated: April 20, 2015
Last verified: April 2015
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.

HIV Infections

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alveolar Macrophage Proteomics in HIV-associated Emphysema

Resource links provided by NLM:

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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.

Biospecimen Retention:   Samples With DNA
blood lung fluid (optional)

Enrollment: 365
Study Start Date: March 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
HIV smokers with emphysema
HIV smokers without emphysema

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00823927

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43026
Sponsors and Collaborators
Philip Diaz
National Institutes of Health (NIH)
Principal Investigator: Philip T Diaz, MD Ohio State University
  More Information

Responsible Party: Philip Diaz, MD, The Ohio State University Identifier: NCT00823927     History of Changes
Other Study ID Numbers: 2005H0197 
Study First Received: January 15, 2009
Last Updated: April 20, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
lung damage
cigarette smoking

Additional relevant MeSH terms:
Pulmonary Emphysema
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on May 30, 2016