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Alveolar Macrophage Proteomics in HIV-associated Emphysema (HIVE)

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. Identifier: NCT00823927
Recruitment Status : Unknown
Verified April 2015 by Philip Diaz, Ohio State University.
Recruitment status was:  Active, not recruiting
First Posted : January 16, 2009
Last Update Posted : April 22, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Philip Diaz, Ohio State University

Brief Summary:
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.

Condition or disease
HIV Emphysema HIV Infections

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.

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Study Type : Observational
Actual Enrollment : 365 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Alveolar Macrophage Proteomics in HIV-associated Emphysema
Study Start Date : March 2006
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema HIV/AIDS

HIV smokers with emphysema
HIV smokers without emphysema

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823927

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

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Responsible Party: Philip Diaz, MD, Ohio State University Identifier: NCT00823927     History of Changes
Other Study ID Numbers: 2005H0197
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Philip Diaz, Ohio State University:
lung damage
cigarette smoking

Additional relevant MeSH terms:
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HIV Infections
Pulmonary Emphysema
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases