Herpesvirus in Idiopathic Pulmonary Fibrosis

The purpose of this study is to: 1) to develop a method to quantify Epstein Barr Virus (EBV) load in lung tissue of humans and to determine whether EBV viral load is significantly higher in lung tissue from patients with idiopathic pulmonary fibrosis (IPF) than in control lung tissue; 2) to determine whether EBV localized to epithelial cells in IPF lungs and to relate epithelial positivity to tissue viral load; 3) to measure viral load in induced sputum from IPF subjects over time in order to determine whether periodic active herpes virus replication occurred in the respiratory tract; and 4) to compare longitudinal measures of viral load in induced sputum with simultaneously collected saliva in order to assess the clinical utility of the two approaches.

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Key information

Conditions

Lung Diseases DNA Virus Infections Herpes Simplex Herpesviridae Infections Herpesvirus Infections Idiopathic Pulmonary Fibrosis Infections Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30322, United States

About this study

IPF is a progressive disease where there is no proven treatment, other than lung transplant. Doctors do not know what causes IPF. We think that IPF is caused by a viral infection, particularly herpes virus. The goal of this experiment is to build the case for a causal link between IPF and herpes virus. This information is important to help us develop new therapies to treat patients with IPF.

We will collect lung tissue at the time of lung transplant surgery from IPF patients and from organ donors as controls. Control lung tissue was collected if it was removed as a part of regular care or would otherwise be discarded. No extra tissue was taken solely for this research project.

We will also perform a prospective longitudinal study on IPF patients and their household partners. IPF subjects are included if they have no other pulmonary disease and the diagnosis of IPF is confirmed by lung biopsy or by clinical and chest CT findings. The control group will consist of subjects without respiratory symptoms or pulmonary diseases who are the household partner or spouse of an enrolled IPF subject and who accompanies the IPF patient to outpatient clinic visits. If there is no household partner, or if the partner is unwilling to participate, we will still enroll the IPF subject who qualifies for the study and is willing to participate. Saliva, induced sputum, and venous blood will be collected from IPF and control subjects after informed consent at each clinic visit. Visits usually are at approximately 3-4 month intervals over a one year period.

Who can participate

Healthy volunteers accepted: Yes

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

For the study on lung tissue, eligible subjects were IPF patients undergoing lung transplant surgery and from organ donors who died from non-pulmonary causes. For the study in clinic, subjects were IPF patients who had no other pulmonary disease other than IPF and the diagnosis of IPF was confirmed by lung biopsy or by clinical and chest CT findings. The control group consisted of subjects without respiratory symptoms or pulmonary diseases who were the household partner or spouse of an enrolled IPF subject and accompanied the IPF patient to outpatient clinic visits.

Exclusion criteria

Failure of the patient to provide informed consent.

Treatment and study plan

Primary outcomes

Viral load

Time frame: 1 year

EBV viral load in induced sputum collected at each clinic visit over a one year period

Secondary outcomes

Viral load

Time frame: 1 year

EBV viral load in saliva collected every clinic visit over a one year period

Other outcomes

Viral load

Time frame: one time point

EBV viral load in lung tissue collected at the tim e of lung transplantation

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2012
Study completion: 2012
First posted: Sep 29, 2005
Registry last updated: May 11, 2017

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