NCT00575185

Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious Mononucleosis

Interventions

Type	Name	Description
DRUG	Valomaciclovir	4 grams orally of valomaciclovir (2 grams BID) for 21 days.
DRUG	placebo	Placebo tablets orally twice daily for 21 days.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-07-01
• Completion: 2010-02-01
• First posted: 2007-12-18
• Last updated: 2017-03-22
• Results posted: 2015-03-17

Locations

1 site across 1 country: United States