Alveolar Macrophage Proteomics in HIV-associated Emphysema

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Philip Diaz

Other

Collaborators

National Institutes of Health (NIH)

Registry information

Acronym: HIVE

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Jan 16, 2009
Registry last updated: Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed