CompletedPhase 1/2

Controlled Trial of Valacyclovir in Infectious Mononucleosis

United States20 participantsStarted 2004-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Proportion of subjects who have at least a 100-fold (2log10) drop in the amount of EBV in their oral washes during the 14-day treatment period

Trial details

NCT IDNCT00274404

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2005-09

View on ClinicalTrials.gov More Infectious Mononucleosis trials