Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274404
Status:
COMPLETED
Last Update Posted:
2011-10-27
First Post:
2006-01-06
Brief Title:
Controlled Trial of Valacyclovir in Infectious Mononucleosis
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 chancerandomizedeither 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None