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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
4 grams orally of valomaciclovir (2 grams BID) for 21 days.
Placebo tablets orally twice daily for 21 days.
University of Minnesota
Minneapolis, Minnesota, United States
Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline
All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline
Time frame: 21 days
Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability
Assessing adverse events in participants to see if this drug causes more or less side effects
Time frame: 15 days
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