Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono6)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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)|
- Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]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
- Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]Assessing adverse events in participants to see if this drug causes more or less side effects
|Study Start Date:||November 2007|
|Study Completion Date:||February 2010|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Valomaciclovir
Valomaciclovir 2 grams orally twice daily for 21 days
4 grams orally of valomaciclovir (2 grams BID) for 21 days.
Placebo Comparator: placebo
placebo 2 tablets twice daily for 21 days
Placebo tablets orally twice daily for 21 days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575185
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Henry H Balfour, MD||Professor of Laboratory Medicine & Pathology, and Pediatrics|