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CompletedNCT00823927HIVEUpdated Nov 1, 2021

Alveolar Macrophage Proteomics in HIV-associated Emphysema

An observational study in HIV, Emphysema and HIV Infections, sponsored by Philip Diaz. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Philip Diaz · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
365
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV
  • Emphysema
  • HIV Infections

Keywords

  • lung damage
  • cigarette smoking
  • HIV-seropositive
  • emphysema
03

In context

Pulmonary Emphysema

187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.

This study's enrollment of 365 is above the median of 74 across 48 observational studies indexed under Pulmonary Emphysema.

Browse Pulmonary Emphysema studies →

Lead sponsor

Philip Diaz is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
365 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Alveolar macrophage proteomes from HIV-seropositive smokers with emphysema

  • 2

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

06

What researchers measure

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.

    Time frame: 3 years

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Study locations

1 site
  • The Ohio State University
    Columbus, Ohio 43026, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00823927
Lead sponsor
Philip Diaz
Collaborators
National Institutes of Health (NIH)
Responsible party
Philip Diaz (MD, Ohio State University) — Sponsor-investigator
First posted
Jan 16, 2009
Start date
Apr 21, 2006
Primary completion
Jun 23, 2008
Completion
Jun 23, 2008
Last update
Nov 1, 2021

Study contacts

Philip T Diaz, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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