- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00274404
Controlled Trial of Valacyclovir in Infectious Mononucleosis
October 26, 2011 updated by: University of Minnesota
Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis
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.
Study Overview
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.
Study Type
Interventional
Enrollment
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455-0392
- University of Minnesota Clinical Virology Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
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Secondary Outcome Measures
Outcome Measure |
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Evaluate the safety and tolerability of valacyclovir
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Evaluate the quantity of EBV in the oral washings
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Correlate severity of illness with the amount of virus in the oral and blood compartments
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Evaluate the areas under the viral load - time curves
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henry H Balfour, MD, University of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
January 6, 2006
First Submitted That Met QC Criteria
January 6, 2006
First Posted (Estimate)
January 10, 2006
Study Record Updates
Last Update Posted (Estimate)
October 27, 2011
Last Update Submitted That Met QC Criteria
October 26, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Virus Diseases
- Immune System Diseases
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease Attributes
- Hematologic Diseases
- DNA Virus Infections
- Leukocyte Disorders
- Epstein-Barr Virus Infections
- Herpesviridae Infections
- Infections
- Communicable Diseases
- Infectious Mononucleosis
- Anti-Infective Agents
- Antiviral Agents
- Valacyclovir
Other Study ID Numbers
- 0311M53430
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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