The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01011712|
Recruitment Status : Recruiting
First Posted : November 11, 2009
Last Update Posted : August 9, 2018
- Infections caused by viruses are common causes of illnesses: the common cold, many ear infections, sore throats, chicken pox, and the flu are caused by different viruses. Usually, these illnesses last only few days or, at most, a few weeks. Some virus infections like influenza are cleared from the body, and others such as the chicken pox virus remain in the body in an inactive state. However, some people may become quite ill when they are infected with a particular virus, possibly because part of their immune system does not respond properly to fight the virus.
- Researchers have discovered some reasons why a person may not be able to clear an infection caused by a virus. Some persons have changes in the genes that involve the immune system that result in the inability to properly control infection with a particular virus. Identifying changes in genes that involve the immune system should help scientists better understand how the immune system works to protect people from infection and may help develop new therapies.
- To study possible immune defects that may be linked to a particular severe viral infection.
- To determine if identified immune defects are genetic in origin.
- Individuals of any age who have or have had a diagnosis of a virus infection that physicians consider to be unusually severe, prolonged, or difficult to treat.
- Relatives of the participants with a severe viral infection may also participate in the study. We will use their blood and/or skin specimens to try to determine if identified immune defects are hereditary.
- Prior to the study, the participant's doctor will give researchers the details of the infection, along with medical records for review. Eligible participants will be invited to the NIH Clinical Center for a full evaluation as an outpatient or inpatient.
- At the Clinical Center, participants will be treated with the best available therapy for the particular viral infection, and researchers will monitor how the infection responds to the treatment.
- Researchers will take intermittent blood samples and conduct other tests (such as skin biopsies) to evaluate the immune system. - During and after the illness, researchers will conduct follow-up visits to determine the course of infection and response to therapy.
|Condition or disease|
|EBV HSV VZV|
Viral infections in the normal host are usually self-limited as the innate and acquired immune systems mount successful antiviral responses. However, in some instances, apparently immunocompetent persons manifest infections with viruses that would otherwise be observed only in severely immunocompromised hosts. For example, cases of herpes simplex virus (HSV) encephalitis, esophagitis orgastritis, cytomegalovirus (CMV) colitis, adenovirus hepatitis or pneumonitis, recurrent or persistent skin infections caused by HSV or varicella zoster virus (VZV), severe warts caused by human papillomavirus (HPV), recurrent respiratory papillomatosis caused by HPV, severe influenza or respiratory syncytial virus pneumonia, and progressive multifocal leukoencephalopathy (PML) due to JC polyomavirus have been described in apparently immunocompetent patients. While a variety of case reports have described severe viral infections in immunocompetent hosts, the pathogenesis of the vast majority of these cases is not understood, and therapy can be unsuccessful.
In this protocol, we will evaluate patients without known immunocompromise, who have severe, persistent, or treatment-refractory viral infections caused by herpesviruses, adenoviruses, polyoma viruses, papillomaviruses, or other viral infections. We will investigate whether certain host or virologic factors predispose these individuals to severe disease. We will also determine the usefulness of various microbiologic tests (e.g., cultures, serology, molecular assays) for following the course of infection in these patients. The physicians in the Clinical Center will provide optimal therapy for these patients, as part of standard of care. Identification of virologic or host factors that predispose these patients to severe viral infections may have important implications for elucidating the pathogenesis of infection and for the development of novel therapies.
|Study Type :||Observational|
|Estimated Enrollment :||325 participants|
|Official Title:||The Natural History of Severe Viral Infections and Characterization of Immune Defects|
|Study Start Date :||November 9, 2009|
- In this study, we will evaluate patients without known or not fully characterized immunodeficiency who have a history of or present with severe, persistent, or treatment-refractory viral infections. Herpesvirus, adenovirus, human papillomavirus ... [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011712
|Contact: Doreen L Garabedian, R.N.||(301) email@example.com|
|Contact: Lesia K Dropulic, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Lesia K Dropulic, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|