Controlled Trial of Valacyclovir in Infectious Mononucleosis

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that an antiviral drug (valacyclovir) will reduce the amount of Epstein-Barr virus (EBV) in the mouths of university students with infectious mononucleosis (mono) while being a safe drug. Because EBV is the cause of mono, it is expected that reduction of the amount of virus could result in faster recovery from the disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Collaborators: Hoffmann-La Roche; Minnesota Medical Foundation
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• Clinical diagnosis of infectious mononucleosis with onset no more the 7 days before enrollment; willingness to sign informed consent

• Willingness to provide blood and oral washing samples at regular intervals

• Females must have a negative urine pregnancy test and agree to use effective contraception (barrier or hormonal) for the first 30 days of the study if assigned to valacyclovir

• Corticosteroids are permitted only if prescribed by the subject's primary physisican for treatment of this acute disease

Exclusion Criteria:

• Previous history of mono

• Pregnant or breast feeding

• End-stage renal or liver disease

• Immunosuppressed due to underlying medical disease and/or immunomodulating medications prior to enrollment

• Onset of present illness >7 days ago