Trial record 2 of 35 for:    mononucleosis

Controlled Trial of Valacyclovir in Infectious Mononucleosis

This study has been completed.
Sponsor:
Collaborators:
Minnesota Medical Foundation
Hoffmann-La Roche
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00274404
First received: January 6, 2006
Last updated: October 26, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Infectious Mononucleosis
Drug: valacyclovir
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

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

Estimated Enrollment: 20
Study Start Date: February 2004
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00274404

Locations
United States, Minnesota
University of Minnesota Clinical Virology Clinic
Minneapolis, Minnesota, United States, 55455-0392
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Minnesota Medical Foundation
Hoffmann-La Roche
Investigators
Principal Investigator: Henry H Balfour, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00274404     History of Changes
Other Study ID Numbers: 0311M53430
Study First Received: January 6, 2006
Last Updated: October 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
infectious mononucleosis
Epstein-Barr virus
valacyclovir
quantitative PCR

Additional relevant MeSH terms:
Infectious Mononucleosis
Communicable Diseases
Infection
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Leukocyte Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014