EncephalitisNCT00001648
Structure of the Herpes Simplex Virus Receptor
An observational study of Encephalitis and Herpes Simplex, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will examine the structure of the receptor molecule for the herpes simplex virus (HSV) and determine if the receptor's structure is related to susceptibility to infection with the virus. There are two types of herpes virus-HSV-1 and HSV-2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Encephalitis, Herpes Simplex, Keratitis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 1997to 13 Apr 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HSV-2 Seronegative Patients:
- Individuals known or likely to be seronegative for HSV-2 will be recruited.
- All racial, gender, and ethnic groups will be considered.
- Adult volunteers at least 18 years of age.
- Volunteers who were seronegative for HSV-2 (regardless of HSV-1 serology) confirmed by Western blot.
- Volunteers are willing to allow investigators to store their blood.
Show all 12Show fewer
- HSV-2 seropositive patients (with or without symptoms):
- All racial and ethnic groups will be considered.
- Volunteers who were seropositive for HSV-2 (regardless of HSV-1 serology) confirmed by Western blot.
- Volunteers are willing to allow investigators to store their blood.
- Normal Controls:
- To determine the frequency of a genetic polymorphism in a population that has not had prior screening for HSV, blood may be obtained from normal control blood donors.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Polymorphism of the Herpes Simplex Virus Receptor
This study will examine the structure of the receptor molecule for the herpes simplex virus (HSV) and determine if the receptor's structure is related to susceptibility to infection with the virus. There are two types of herpes virus-HSV-1 and HSV-2. HSV-1 commonly causes cold sores, and HSV-2 usually causes genital herpes. The herpes virus enters (infects) cells through protein molecules on the cell's surface. This study will explore possible differences between the structure of the HSV receptor molecule in different people to understand better how infection occurs. The study will also look at proteins on white blood cells (Fc receptors, cytokines and mannose binding protein) that may influence the risk of infection with HSV. Information from this study may lead to new treatments to prevent HSV infection.
People 18 years of age and older who are infected with HSV and people who are not infected with the virus may be eligible for this study. Participants will have blood drawn to confirm whether or not they have been infected with the virus. The blood sample will also be used to study the genes for the HSV receptor, Fc receptors, cytokines, mannose binding protein and related proteins on the white blood cells. No more than 40 milliliters (8 teaspoons) of blood will be drawn.
Participants who are found to have antibodies to HSV-2 will be offered counseling and advice on practicing safe sex techniques to help prevent sexually transmitted diseases, including HSV-2 infection.
Read the detailed description
Herpes simplex virus (HSV) causes genital, orolabial, or cutaneous lesions, keratitis, and encephalitis. Recently cellular receptors for HSV were isolated. The purpose of this study is to identify polymorphisms in the sequence of HSV receptor, cytokines or chemokines and to determine whether these polymorphisms correlate with susceptibility to infection by HSV or with symptoms of HSV. Blood samples from individuals who are seronegative, or seropositive (with or without symptoms of infection) for HSV-2 will be analyzed to determine the sequences of the HSV receptors, cytokines, chemokines, or related proteins. If a new genetic polymorphism is found, additional blood samples from individuals who are seropositive for HSV and from random blood donors will be analyzed to determine the frequency of the polymorphisms in seropositives and in the general population. Knowledge gained from this study should provide important insights into mechanisms of infection by HSV and may lead to novel therapies to block infection.
- Conditions
- Encephalitis, Herpes Simplex, Keratitis, Mouth Disease, Skin Disease
- Keywords
- HVEM Gene, HSV, Herpes Simplex Virus
- Medical subject headings
- Encephalitis, Herpes Simplex, Keratitis, Mouth Diseases, Skin Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start20 Aug 1997
- Study completion13 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EncephalitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001648
- Sponsor's protocol ID
- 970166
- Other IDs
- 97-I-0166
- Status last verified
- 13 Apr 2010
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Montgomery RI, Warner MS, Lum BJ, Spear PG. Herpes simplex virus-1 entry into cells mediated by a novel member of the TNF/NGF receptor family. Cell. 1996 Nov 1;87(3):427-36. doi: 10.1016/s0092-8674(00)81363-x.
PubMed 8898196Marsters SA, Ayres TM, Skubatch M, Gray CL, Rothe M, Ashkenazi A. Herpesvirus entry mediator, a member of the tumor necrosis factor receptor (TNFR) family, interacts with members of the TNFR-associated factor family and activates the transcription factors NF-kappaB and AP-1. J Biol Chem. 1997 May 30;272(22):14029-32. doi: 10.1074/jbc.272.22.14029.
PubMed 9162022Feng Y, Broder CC, Kennedy PE, Berger EA. HIV-1 entry cofactor: functional cDNA cloning of a seven-transmembrane, G protein-coupled receptor. Science. 1996 May 10;272(5263):872-7. doi: 10.1126/science.272.5263.872.
PubMed 8629022
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of the Herpes Simplex Virus Receptor
- ClinicalTrials.gov ID
- NCT00001648
- Acronym / sponsor ID
- 970166
- Conditions
- Encephalitis, Herpes Simplex, Keratitis, Mouth Disease, Skin Disease
- Keywords
- HVEM Gene, HSV, Herpes Simplex Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 20 Aug 1997
- Study completion
- 13 Apr 2010
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the structure of the receptor molecule for the herpes simplex virus (HSV) and determine if the receptor's structure is related to susceptibility to infection with the virus. There are two types of herpes virus-HSV-1 and HSV-2. HSV-1 commonly causes cold sores, and HSV-2 usually causes genital herpes. The herpes virus enters (infects) cells through protein molecules on the cell's surface. This study will explore possible differences between the structure of the HSV receptor molecule in different people to understand better how infection occurs. The study will also look at proteins on white blood cells (Fc receptors, cytokines and mannose binding protein) that may influence the risk of infection with HSV. Information from this study may lead to new treatments to prevent HSV infection.
People 18 years of age and older who are infected with HSV and people who are not infected with the virus may be eligible for this study. Participants will have blood drawn to confirm whether or not they have been infected with the virus. The blood sample will also be used to study the genes for the HSV receptor, Fc receptors, cytokines, mannose binding protein and related proteins on the white blood cells. No more than 40 milliliters (8 teaspoons) of blood will be drawn.
Participants who are found to have antibodies to HSV-2 will be offered counseling and advice on practicing safe sex techniques to help prevent sexually transmitted diseases, including HSV-2 infection.
Detailed description
Herpes simplex virus (HSV) causes genital, orolabial, or cutaneous lesions, keratitis, and encephalitis. Recently cellular receptors for HSV were isolated. The purpose of this study is to identify polymorphisms in the sequence of HSV receptor, cytokines or chemokines and to determine whether these polymorphisms correlate with susceptibility to infection by HSV or with symptoms of HSV. Blood samples from individuals who are seronegative, or seropositive (with or without symptoms of infection) for HSV-2 will be analyzed to determine the sequences of the HSV receptors, cytokines, chemokines, or related proteins. If a new genetic polymorphism is found, additional blood samples from individuals who are seropositive for HSV and from random blood donors will be analyzed to determine the frequency of the polymorphisms in seropositives and in the general population. Knowledge gained from this study should provide important insights into mechanisms of infection by HSV and may lead to novel therapies to block infection.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Individuals known or likely to be seronegative for HSV-2 will be recruited.
- All racial, gender, and ethnic groups will be considered.
- Adult volunteers at least 18 years of age.
- Volunteers who were seronegative for HSV-2 (regardless of HSV-1 serology) confirmed by Western blot.
- Volunteers are willing to allow investigators to store their blood.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 8898196Montgomery RI, Warner MS, Lum BJ, Spear PG. Herpes simplex virus-1 entry into cells mediated by a novel member of the TNF/NGF receptor family. Cell. 1996 Nov 1;87(3):427-36. doi: 10.1016/s0092-8674(00)81363-x.
- Background: PubMed 9162022Marsters SA, Ayres TM, Skubatch M, Gray CL, Rothe M, Ashkenazi A. Herpesvirus entry mediator, a member of the tumor necrosis factor receptor (TNFR) family, interacts with members of the TNFR-associated factor family and activates the transcription factors NF-kappaB and AP-1. J Biol Chem. 1997 May 30;272(22):14029-32. doi: 10.1074/jbc.272.22.14029.
- Background: PubMed 8629022Feng Y, Broder CC, Kennedy PE, Berger EA. HIV-1 entry cofactor: functional cDNA cloning of a seven-transmembrane, G protein-coupled receptor. Science. 1996 May 10;272(5263):872-7. doi: 10.1126/science.272.5263.872.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalitis and Herpes Simplex, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001648, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.