Alveolar Macrophage Proteomics in HIV-associated Emphysema

NCT00823927 | Completed DMC

• 1 other identifier: 2005H0197
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Emphysema; HIV Infections

Keywords

lung damage; cigarette smoking; HIV-seropositive; emphysema

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema

2

Alveolar macrophages proteomes of both HIV+ smokers without emphysema and HIV- smokers.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philip Diaz: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43026, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood lung fluid (optional)

MeSH Terms

Conditions

Emphysema; HIV Infections; Cigarette Smoking; HIV Seropositivity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Philip T Diaz, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: April 21, 2006
• Primary Completion: June 23, 2008
• Study Completion: June 23, 2008
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (1)