Clinical Trial: Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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 Summary: 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.
Sponsor: University of Minnesota - Clinical and Translational Science Institute
Current Primary Outcome: Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline [ Time Frame: 21 days ]
Original Primary Outcome: To determine if treatment with valomaciclovir will significantly improve the clinical symptoms and reduce the viral burden in immunocompetent adults with IM due to primary EBV infection. [ Time Frame: 21 days ]
Current Secondary Outcome: Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability [ Time Frame: 15 days ]
Original Secondary Outcome: Evaluate the safety and tolerability of valomaciclovir. [ Time Frame: 15 ]
Information By: University of Minnesota - Clinical and Translational Science Institute
Dates:
Date Received: December 14, 2007
Date Started: November 2007
Date Completion:
Last Updated: February 16, 2017
Last Verified: February 2017