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Controlled Trial of Valacyclovir in Infectious Mononucleosis

Primary Purpose

Infectious Mononucleosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
valacyclovir
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infectious Mononucleosis focused on measuring infectious mononucleosis, Epstein-Barr virus, valacyclovir, quantitative PCR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota Clinical Virology Clinic

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
January 6, 2006
Last Updated
October 26, 2011
Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation, Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00274404
Brief Title
Controlled Trial of Valacyclovir in Infectious Mononucleosis
Official Title
Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Minnesota Medical Foundation, Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
University of Minnesota students 18 years of age or older who are referred by the Boynton student health service during the first 7 days of infectious mononucleosis are eligible to participate. All of the subjects who enroll will be allowed to complete the study, but only the information from those students who truly have mono due to a primary infection with EBV as determined by laboratory tests will be used for the results. The students will be assigned by chance(randomized)either to receive the antiviral drug valacyclovir at a dosage of a 1 gram tablet every 8 hours for 14 days or no antiviral drug. Nine research clinic visits over 180 days are scheduled for clinical exams, histories, and collection of mouth and blood samples. The amount of EBV in the mouth and blood will be measured by a molecular virology research test called real-time TaqMan polymerase chain reaction. The severity of illness will be evaluated using a scale that measures the degree of physical activity and intensity of symptoms. The safety of the drug will be monitored by periodically checking the blood cell counts, and assessing liver and kidney function among other parameters. Personnel who do the lab work and analyze the data will not know the subjects' study drug assignments so that the data can be collected and analyzed objectively. The study will remain open to enrollment until 20 subjects with laboratory-confirmed primary EBV have been enrolled and followed for at least 2 weeks. The study will end when all subjects complete all scheduled study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Mononucleosis
Keywords
infectious mononucleosis, Epstein-Barr virus, valacyclovir, quantitative PCR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
valacyclovir
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Evaluate the safety and tolerability of valacyclovir
Title
Evaluate the quantity of EBV in the oral washings
Title
Correlate severity of illness with the amount of virus in the oral and blood compartments
Title
Evaluate the areas under the viral load - time curves

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry H Balfour, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Clinical Virology Clinic
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0392
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
Links:
URL
http://cvp.umn.edu
Description
University of Minnesota Clinical Virology Programs website

Learn more about this trial

Controlled Trial of Valacyclovir in Infectious Mononucleosis

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