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Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus Clinical research trials and Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus. Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus clinical trial. Human subjects often get the best healthcare possible for their Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus  Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus
Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus
For Condition: Healthy,Epstein Barr Virus Infection
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. 18 years of age or older and deemed healthy by current medical status and laboratory tests. 2. Willing to be seen every three months for one year. 3. Have symptomatic recurrent genital herpes disease confirmed by their private medical doctor. 4. 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. 5. Recurrence rate between 3 and 9 recurrences a year. 6. Have never taken or have been off HSV suppressive therapy for three months prior to entering study. 7. In opinion of investigator, subjects must be able to comply with protocol requirements. EXCLUSION CRITERIA: 1. 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. 2. Subjects with a history of 10 or more HSV recurrences per year. 3. Impaired real function as defined by serum creatine greater than 1.5 mg/dl (133uM). 4. Impaired hepatic function as defined by an alanine transaminase (ALT) level greater than 3 times the normal upper limit. 5. Known hypersensitivity to acyclovir, valaciclovir, famciclovir, or ganciclovir. 6. Malabsorption syndrome or other gastro-intestinal dysfunction that might impair drug dynamics. 7. Women contemplating pregnancy within the year's duration of receiving valaciclovir from us. 8. 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. 9. Positive pregnancy test (or pregnant females or nursing mothers). 10. Swallowing disorders which would make gargling difficult.
Total Enrollment: 125
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000163; 00-I-0163
Study Start Date: June 23, 2000
Record last reviewed: May 27, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005924
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Effects of Long-Term Treatment with Valaciclovir (Valtrex) on Epstein-Barr Virus
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