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| Sponsor: | University of Minnesota - Clinical and Translational Science Institute |
|---|---|
| Collaborators: |
Minnesota Medical Foundation Hoffmann-La Roche |
| Information provided by (Responsible Party): | University of Minnesota - Clinical and Translational Science Institute |
| ClinicalTrials.gov Identifier: | NCT00274404 |
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 I Phase II |
| 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 |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Minnesota | |
| University of Minnesota Clinical Virology Clinic | |
| Minneapolis, Minnesota, United States, 55455-0392 | |
| Principal Investigator: | Henry H Balfour, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
| 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 |
|
infectious mononucleosis Epstein-Barr virus valacyclovir quantitative PCR |
|
Communicable Diseases Infection Infectious Mononucleosis 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 |