We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823927
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.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Philip Diaz, The Ohio State University
  Purpose
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
HIV Emphysema 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 Philip Diaz, The Ohio State University:

Primary Outcome Measures:
  • 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)

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)
Groups/Cohorts
1
HIV smokers with emphysema
2
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00823927


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

Responsible Party: Philip Diaz, MD, The Ohio State University
ClinicalTrials.gov Identifier: NCT00823927     History of Changes
Other Study ID Numbers: 2005H0197
First Submitted: January 15, 2009
First Posted: January 16, 2009
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Philip Diaz, The Ohio State University:
lung damage
cigarette smoking
HIV-seropositive
emphysema

Additional relevant MeSH terms:
HIV Infections
Emphysema
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