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Structure of the Herpes Simplex Virus Receptor

Primary Purpose

Encephalitis, Herpes Simplex, Keratitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Encephalitis focused on measuring HVEM Gene, HSV, Herpes Simplex Virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA: 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. 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.

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001648
Brief Title
Structure of the Herpes Simplex Virus Receptor
Official Title
Polymorphism of the Herpes Simplex Virus Receptor
Study Type
Observational

2. Study Status

Record Verification Date
April 13, 2010
Overall Recruitment Status
Completed
Study Start Date
August 20, 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 13, 2010 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Herpes Simplex, Keratitis, Mouth Disease, Skin Disease
Keywords
HVEM Gene, HSV, Herpes Simplex Virus

7. Study Design

Enrollment
60 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: 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. 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.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8898196
Citation
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.
Results Reference
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PubMed Identifier
9162022
Citation
Marsters 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.
Results Reference
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PubMed Identifier
8629022
Citation
Feng 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.
Results Reference
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Structure of the Herpes Simplex Virus Receptor

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