Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005924
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2000-06-24
Brief Title:
Effects of Long-Term Treatment With Valaciclovir Valtrex on Epstein-Barr Virus
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Persistence of Epstein-Barr Virus in Vivo
Status:
COMPLETED
Status Verified Date:
2010-02-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of long-term antiviral therapy with valaciclovir Valtrex on Epstein-Barr virus infection This virus infects more than 95 percent of people in the United States Most are infected in childhood have no symptoms and are unaware of their infection People infected as adolescents or adults may develop infectious mononucleosis which usually resolves completely Once infected most people shed the virus from their throat occasionally and all carry the virus in their white blood cells for life This study will determine whether the amount of virus in the blood declines or disappears with long-term valaciclovir treatment
Normal volunteers who are not taking any antiviral medicines and patients enrolled in NIHs protocol no 97-I-0168 Evaluation of Valaciclovir for Prevention of Herpes Simplex Virus Transmission or Glaxo-Wellcome protocol HS2AB 3009 at collaborating centers may be eligible for this study Patients in the multi-center study must be about to start valaciclovir therapy for at least 1 year All candidates must be 18 years of age or older
Study participants will be seen in clinic for about 1 hour every 3 months for a year During these visits they will provide information about the medicines they are taking gargle twice with salt water and spit the fluid into a tube and have blood drawn no more than 8 teaspoons each visit The blood and gargled fluid will be tested for the amount of Epstein-Barr virus and antibodies to the virus Blood samples will also be tested for HLA type in order to do immunologic studies in the laboratory HLA is a marker of the immune system that is similar to blood-typing testing
The results in people taking valaciclovir will be compared with those in people not taking the drug People whose results show the virus has disappeared from the body will continue to be followed twice a year for 5 years with the blood and gargling tests to continue to look for evidence of virus Also people who develop symptoms resembling mononucleosis eg enlarged lymph nodes with fever and sore throat will be asked to have their blood tested for the virus
Normal volunteers who are not taking any antiviral medicines and patients enrolled in NIHs protocol no 97-I-0168 Evaluation of Valaciclovir for Prevention of Herpes Simplex Virus Transmission or Glaxo-Wellcome protocol HS2AB 3009 at collaborating centers may be eligible for this study Patients in the multi-center study must be about to start valaciclovir therapy for at least 1 year All candidates must be 18 years of age or older
Study participants will be seen in clinic for about 1 hour every 3 months for a year During these visits they will provide information about the medicines they are taking gargle twice with salt water and spit the fluid into a tube and have blood drawn no more than 8 teaspoons each visit The blood and gargled fluid will be tested for the amount of Epstein-Barr virus and antibodies to the virus Blood samples will also be tested for HLA type in order to do immunologic studies in the laboratory HLA is a marker of the immune system that is similar to blood-typing testing
The results in people taking valaciclovir will be compared with those in people not taking the drug People whose results show the virus has disappeared from the body will continue to be followed twice a year for 5 years with the blood and gargling tests to continue to look for evidence of virus Also people who develop symptoms resembling mononucleosis eg enlarged lymph nodes with fever and sore throat will be asked to have their blood tested for the virus
Detailed Description:
Epstein-Barr virus EBV is the cause of heterophile-positive infectious mononucleosis After primary EBV infection the virus persists in resting memory B lymphocytes and can be detected in oropharyngeal secretions Short term 1 month treatment with oral acyclovir which inhibits EBV replication results in loss of virus shedding from the oropharynx but the virus persists in B cells The goal of this study is to determine if EBV will no longer persist in B cells in patients treated with long term 20 month oral valaciclovir which is metabolized to acyclovir Blood samples and throat washings will be obtained every three months from individuals who are receiving valaciclovir for treatment of genital herpes simplex virus infection These samples will be analyzed for EBV DNA to determine if the level of EBV DNA declines or becomes negative with long term antiviral therapy If the level of EBV DNA becomes undetectable in EBV-seropositive persons during the study we will ask the patients to return twice a year for five years or if they develop symptoms of mononucleosis so that EBV DNA in their blood and throat washings can be studied Knowledge gained from this study should provide important insights into the mechanism of persistence of EBV infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-I-0163 | None | None | None |