Spots Global Cancer Trial Database for Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection
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Trial Identification
Brief Title: Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection
Official Title: Randomized, Placebo-Controlled, Double-Blind Study to Assess Clinical and Antiviral Activity of Valomaciclovir (EPB 348) in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono 6)
Study ID: NCT00575185
Conditions
Study Description
Brief Summary: This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.
Detailed Description: Subjects will be seen 2 times a week for 3 weeks and then weekly for 3 weeks. Clinical findings, clinical lab tests, EBV viral loads, and EBV antibody titers will be obtained at each clinic visit.
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota, Minneapolis, Minnesota, United States
Contact Details
Name: Henry H Balfour, MD
Affiliation: Professor of Laboratory Medicine & Pathology, and Pediatrics
Role: PRINCIPAL_INVESTIGATOR
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