NCT00274404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

October 27, 2011

Status Verified

October 1, 2011

Enrollment Period

1.6 years

First QC Date

January 6, 2006

Last Update Submit

October 26, 2011

Conditions

Infectious Mononucleosis

Keywords

infectious mononucleosisEpstein-Barr virusvalacyclovirquantitative PCR

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Evaluate the safety and tolerability of valacyclovir

  • Evaluate the quantity of EBV in the oral washings

  • Correlate severity of illness with the amount of virus in the oral and blood compartments

  • Evaluate the areas under the viral load - time curves

Interventions

valacyclovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Clinical Virology Clinic

Minneapolis, Minnesota, 55455-0392, United States

Location

Related Publications (1)

  • Balfour HH, Jr., Hokanson KM, Schacherer RM, Fietzer CM, Schmeling DO, Brundage RC. A controlled trial of valacyclovir in infectious mononucleosis. Presented at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington, DC, December 18, 2005. Abstract V1392

    RESULT

Related Links

MeSH Terms

Conditions

Infectious MononucleosisEpstein-Barr Virus Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesTumor Virus Infections

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Henry H Balfour, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2006

First Posted

January 10, 2006

Study Start

February 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

October 27, 2011

Record last verified: 2011-10

Locations

US(1)