NCT00001648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
10.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2010

Completed
Last Updated

July 2, 2017

Status Verified

April 13, 2010

First QC Date

November 3, 1999

Last Update Submit

June 30, 2017

Conditions

Keywords

HVEM GeneHSVHerpes Simplex Virus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 8898196BACKGROUND
  • 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.

    PMID: 9162022BACKGROUND
  • 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.

    PMID: 8629022BACKGROUND

MeSH Terms

Conditions

EncephalitisHerpes SimplexKeratitisMouth DiseasesSkin Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin and Connective Tissue DiseasesCorneal DiseasesEye DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

August 20, 1997

Study Completion

April 13, 2010

Last Updated

July 2, 2017

Record last verified: 2010-04-13

Locations