Infectious MononucleosisPhase 1/2NCT00274404
Controlled Trial of Valacyclovir in Infectious Mononucleosis
A Phase 1/2 study testing valacyclovir in people with Infectious Mononucleosis, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Mononucleosis
- What is being tested?
- valacyclovir
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Sep 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Clinical Virology Clinic
Minneapolis, Minnesota, 55455-0392
About this study
Official title: 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.
Read the 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.
- Conditions
- Infectious Mononucleosis
- Being tested
- valacyclovir
- Keywords
- infectious mononucleosis, Epstein-Barr virus, valacyclovir, quantitative PCR
- Medical subject headings
- Infectious Mononucleosis, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valacyclovirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startFeb 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious MononucleosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Medical Foundation, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Henry H Balfour, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274404
- Sponsor's protocol ID
- 0311M53430
- Status last verified
- Oct 2011
- First submitted
- 6 Jan 2006
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study Assessing the Antiviral Activity and Safety of Valacyclovir in Primary Infectious Mononucleosis
- ClinicalTrials.gov ID
- NCT00274404
- Acronym / sponsor ID
- 0311M53430
- Conditions
- Infectious Mononucleosis
- Keywords
- infectious mononucleosis, Epstein-Barr virus, valacyclovir, quantitative PCR
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Medical Foundation, Hoffmann-La Roche
- Study start
- Feb 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valacyclovir | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- Results publicationBalfour 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
- University of Minnesota Clinical Virology Programs websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry H Balfour, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing valacyclovir in people with Infectious Mononucleosis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.