Alveolar Macrophage Proteomics in HIV-associated Emphysema

HIV Infections Clinical Trial

— HIVE  

Official title:

Alveolar Macrophage Proteomics in HIV-associated Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823927
• Other study ID #: 2005H0197
• Secondary ID: 2005H0197
• Status: Completed
• Start date: April 21, 2006
• Est. completion date: June 23, 2008

Study information

• Verified date: October 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: June 23, 2008
• Est. primary completion date: June 23, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysema
• HIV
• HIV Infections
• Pulmonary Emphysema

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Philip Diaz	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	examine the natural history of smoking related lung damage in patients with HIV	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.	3 years