Epstein Barr Virus InfectionNCT00005924
Effects of Long-Term Treatment With Valaciclovir (Valtrex) on Epstein-Barr Virus
An observational study of Epstein Barr Virus Infection and Healthy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epstein Barr Virus Infection, Healthy
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2000to 2 Feb 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
- 18 years of age or older and deemed healthy by current medical status and laboratory tests.
- Willing to be seen every three months for one year.
- Have symptomatic recurrent genital herpes disease confirmed by their private medical doctor.
- Eligible for suppressive antiviral therapy for genital herpes disease: history of genital herpes AND either a positive culture for HSV from the genital area or a positive serology for HSV-2 from the patient's private physician. If the subject does not have a positive HSV genital culture or HSV-2 serology, we will confirm the diagnosis by an HSV-2 Western Blot.
- Recurrence rate between 3 and 9 recurrences a year.
- Have never taken or have been off HSV suppressive therapy for three months prior to entering study.
- In opinion of investigator, subjects must be able to comply with protocol requirements.
Who cannot join
- Subjects who are known or suspected to be immunocompromised. This includes subjects receiving immunosuppressive therapy, subjects with malignancy or subjects who acknowledge being seropositive for HIV.
- Subjects with a history of 10 or more HSV recurrences per year.
- Impaired real function as defined by serum creatine greater than 1.5 mg/dl (133uM).
- Impaired hepatic function as defined by an alanine transaminase (ALT) level greater than 3 times the normal upper limit.
- Known hypersensitivity to acyclovir, valaciclovir, famciclovir, or ganciclovir.
- Malabsorption syndrome or other gastro-intestinal dysfunction that might impair drug dynamics.
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- Women contemplating pregnancy within the year's duration of receiving valaciclovir from us.
- Women of child bearing potential not using an effective method of contraception. Effective contraception is use of birth control pills or use of a barrier method (e.g. condom) with a spermicide.
- Positive pregnancy test (or pregnant females or nursing mothers).
- Swallowing disorders which would make gargling difficult.
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: Persistence of Epstein-Barr Virus in Vivo
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 NIH's 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.
Read more
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 (e.g., enlarged lymph nodes with fever and sore throat) will be asked to have their blood tested for the virus.
Read the 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.
- Conditions
- Epstein Barr Virus Infection, Healthy
- Keywords
- B Cell, Epstein-Barr Virus
- Medical subject headings
- Epstein-Barr Virus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2000 (estimated)
- Study start23 Jun 2000
- Study completion2 Feb 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 Epstein Barr Virus InfectionStudies 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
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005924
- Sponsor's protocol ID
- 000163
- Other IDs
- 00-I-0163
- Status last verified
- 2 Feb 2010
- First submitted
- 24 Jun 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Khan G, Miyashita EM, Yang B, Babcock GJ, Thorley-Lawson DA. Is EBV persistence in vivo a model for B cell homeostasis? Immunity. 1996 Aug;5(2):173-9. doi: 10.1016/s1074-7613(00)80493-8.
PubMed 8769480Miyashita EM, Yang B, Lam KM, Crawford DH, Thorley-Lawson DA. A novel form of Epstein-Barr virus latency in normal B cells in vivo. Cell. 1995 Feb 24;80(4):593-601. doi: 10.1016/0092-8674(95)90513-8.
PubMed 7532548Babcock GJ, Decker LL, Volk M, Thorley-Lawson DA. EBV persistence in memory B cells in vivo. Immunity. 1998 Sep;9(3):395-404. doi: 10.1016/s1074-7613(00)80622-6.
PubMed 9768759
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
- Persistence of Epstein-Barr Virus in Vivo
- ClinicalTrials.gov ID
- NCT00005924
- Acronym / sponsor ID
- 000163
- Conditions
- Epstein Barr Virus Infection, Healthy
- Keywords
- B Cell, Epstein-Barr Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 Jun 2000
- Study completion
- 2 Feb 2010
- First posted
- 26 Jun 2000 (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 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 NIH's 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 (e.g., 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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
Key exclusion criteria (10 listed)
- Subjects who are known or suspected to be immunocompromised. This includes subjects receiving immunosuppressive therapy, subjects with malignancy or subjects who acknowledge being seropositive for HIV.
- Subjects with a history of 10 or more HSV recurrences per year.
- Impaired real function as defined by serum creatine greater than 1.5 mg/dl (133uM).
- Impaired hepatic function as defined by an alanine transaminase (ALT) level greater than 3 times the normal upper limit.
- Known hypersensitivity to acyclovir, valaciclovir, famciclovir, or ganciclovir.
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 8769480Khan G, Miyashita EM, Yang B, Babcock GJ, Thorley-Lawson DA. Is EBV persistence in vivo a model for B cell homeostasis? Immunity. 1996 Aug;5(2):173-9. doi: 10.1016/s1074-7613(00)80493-8.
- Background: PubMed 7532548Miyashita EM, Yang B, Lam KM, Crawford DH, Thorley-Lawson DA. A novel form of Epstein-Barr virus latency in normal B cells in vivo. Cell. 1995 Feb 24;80(4):593-601. doi: 10.1016/0092-8674(95)90513-8.
- Background: PubMed 9768759Babcock GJ, Decker LL, Volk M, Thorley-Lawson DA. EBV persistence in memory B cells in vivo. Immunity. 1998 Sep;9(3):395-404. doi: 10.1016/s1074-7613(00)80622-6.
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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 Epstein Barr Virus Infection and Healthy, 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 7 inclusion and 10 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 NCT00005924, 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.