| Conditions: |
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Herpesvirus - Adenovirus - Cytomegalovirus - Human Papillomavirus - Human Polyomavirus - Influenza Virus - Rhinovirus - Coronavirus - Respiratory Syncytial Virus |
| Purpose: |
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Background:
- 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.
Objectives:
- 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.
Eligibility:
- 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.
Design:
- 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.
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| Study Summary: |
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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.
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| Criteria: |
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- INCLUSION CRITERIA:
(Participants)
Participants must meet all the following inclusion criteria in order to participate in
this study:
1. Children or adults (regardless of age) without known immunocompromise and with a
definitively diagnosed severe viral infection, including infection caused by
herpesviruses (HSV-1, HSV-2, CMV, EBV, VZV, HHV-6, HHV-7, HHV-8), human
papillomavirus (e.g., severe recalcitrant warts), adenovirus, polyomavirus (such as
JC virus and BK virus), or influenza virus. Viral infections that would be considered
"opportunistic-like", such as herpesvirus esophagitis, herpesvirus encephalitis, CMV
colitis, or progressive multifocal leukoencephalopathy (caused by the JC polyoma
virus), will be of particular interest in this protocol.
OR
Children or adults with a well-documented prior, severe, persistent, or treatment
refractory viral infection(s), who have clinically recovered from the viral infection
within the past year. If such a patient is not able to visit the NIH for evaluation,
his or her personal physician may mail-in blood or other clinical specimens to the
NIH for analysis of possible immune defects and for analysis of the virus for
mutations, if indicated.
2. Ongoing care by a referring physician.
3. Willingness to allow storage of blood and tissue samples for future analyses.
(Relatives)
Relatives (2 years or above) may be recruited to establish the genetic origin of immune
defects that may be identified in the study subjects. We may obtain blood, buccal swabs or
a skin biopsy from the relatives.
1. Males and females will be accepted.
2. Adult relatives or the guardians of minor relatives must be willing and capable of
providing informed consent after review of protocol procedures that are described in
the consent form, with an appropriate study team member.
3. Participating relative agree to have blood stored for future studies of the immune
system.
EXCLUSION CRITERIA:
Participants meeting any of the following exclusion criteria at baseline will be excluded
from study participation:
1. Patients with previously diagnosed conditions associated with immunodeficiency (e.g.,
a history of HIV infection or a positive test for HIV) or patients with conditions
requiring either daily systemic corticosteroids exceeding a dose equivalent to10
mg/day of prednisone or other significant immunosuppressant therapy (e.g., organ or
stem cell transplant recipients).
Note: Patients will be included if treatment with steroids or other immunosuppressive
medication was begun to reduce disease associated with the infection and instituted
AFTER the viral disease began.
2. Women who are pregnant.
3. Any condition or major comorbidity that the study investigators believe will
compromise the patient's ability to comply with the requirements of the study.
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| NCT ID: |
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NCT01011712 |
| Primary Contact: |
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Principal Investigator
Lesia K Dropulic, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Lesia K Dropulic, M.D.
Phone: (301) 496-7675
Email: dropulicl@mail.nih.gov
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| Backup Contact: |
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N/A |
| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |