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Infectious MononucleosisPhase 1/2Mono6NCT00575185

Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection

A Phase 1/2 study testing Valomaciclovir in people with Infectious Mononucleosis, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Infectious Mononucleosis
What is being tested?
Valomaciclovir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
1 siteUnited States
Study dates
Nov 2007to Feb 2010
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 15 years or older
  • Within 14 days of initial symptoms of present illness diagnosed by a health care provider as infectious mononucleosis and confirmed to be due to primary EBV by antibody profile. The criteria for antibody confirmation of primary EBV at the screening visit are: 1)Positive for anti-EBV VCA IgM antibody and negative for anti-EBV EBNA1 IgG antibody; 2)EBV antibody testing will be done in the Clinical Virology Research Laboratory using commercial ELISA kits (Diamedix Corporation, Miami, FL).
  • Willingness to sign the Informed Consent Form (ICF)
  • Willingness to contribute samples of blood and oral washings at regular intervals
  • Males and females must use effective contraception during treatment and for at least 90 days following treatment
  • Negative pregnancy test result at the Screening Visit for females of childbearing potential (including females who have had a bilateral tubal ligation). Female patients of childbearing potential must be willing to use an approved method of double-barrier contraception (hormonal plus barrier or barrier plus barrier, eg, diaphragm plus condom) from the time of first dose administration until 90 days after completion of dosing and male patients with female partners of childbearing potential must be willing to use a condom. Patients who are sterile or infertile (defined as those who are postmenopausal or have undergone a complete hysterectomy) are eligible.
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  • Estimated creatinine clearance (Cockcroft and Gault method) ≥ 60 ml/min
  • Absolute neutrophil count ≥ 1000 cells/microliter
  • Platelets ≥ 100,000/microliter
  • Hemoglobin ≥ 9.5 g/dL

Who cannot join

  • Previous history of infectious mononucleosis-like illness
  • Immunosuppressed due to medical disease and/or immunosuppressive or immunomodulating medications (e.g., corticosteroids prior to enrollment, cytotoxic drugs, interferons)
  • Another intercurrent viral infection (including HIV), based on history or referring physician medical evaluation
  • More than 7 days elapsed since onset of illness (including screening time)
  • The following concomitant medications are prohibited: probenecid, trimethoprim, myelosuppressive therapies, and medications known to be nephrotoxic
  • Breast feeding during the study
  • Corticosteroids are not permitted. If they are prescribed by the subject's primary physician for treatment of this acute disease after the subject has enrolled, the subject will be replaced.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: Randomized, Placebo-Controlled, Double-Blind Study to Assess Clinical and Antiviral Activity of Valomaciclovir (EPB 348) in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono 6)

This will be a randomized, placebo-controlled, double-blind single-center proof of concept study to evaluate the anti-EBV activity of 4 grams of valomaciclovir (2 grams BID) for 21 days in subjects with infectious mononucleosis documented to be caused by primary EBV infection. Otherwise healthy subjects (≥15 years old) referred to us with a clinical diagnosis of primary infectious mononucleosis will be screened and those with laboratory-confirmed primary EBV infection will be enrolled.

Read the detailed description

Subjects will be seen 2 times a week for 3 weeks and then weekly for 3 weeks. Clinical findings, clinical lab tests, EBV viral loads, and EBV antibody titers will be obtained at each clinic visit.

Being tested
Valomaciclovir, placebo
Keywords
Mono, Mononucleosis, Epstein-Barr virus
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.

  • ValomaciclovirDrug

    4 grams orally of valomaciclovir (2 grams BID) for 21 days.

  • placeboDrug

    Placebo tablets orally twice daily for 21 days.

Study groups in NCT00575185
Study groupRoleWhat they receive
ValomaciclovirActive comparatorValomaciclovir 2 grams orally twice daily for 21 days
Receives: Drug: Valomaciclovir
placeboPlacebo comparatorplacebo 2 tablets twice daily for 21 days
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline

    All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline

    Measured: 21 days

Secondary outcomes (1)

  1. Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability

    Assessing adverse events in participants to see if this drug causes more or less side effects

    Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2009
  4. Study completionFeb 2010

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00575185
Sponsor's protocol ID
0709M16341
Acronym
Mono6
Status last verified
Feb 2017
First submitted
14 Dec 2007
Last updated
22 Mar 2017
Data monitoring committee
Yes

Publications

  • Balfour HH Jr, Holman CJ, Hokanson KM, Lelonek MM, Giesbrecht JE, White DR, Schmeling DO, Webb CH, Cavert W, Wang DH, Brundage RC. A prospective clinical study of Epstein-Barr virus and host interactions during acute infectious mononucleosis. J Infect Dis. 2005 Nov 1;192(9):1505-12. doi: 10.1086/491740. Epub 2005 Sep 26.

    PubMed 16206064

  • Balfour HH Jr, Hokanson KM, Schacherer RM, Fietzer CM, Schmeling DO, Holman CJ, Vezina HE, Brundage RC. A virologic pilot study of valacyclovir in infectious mononucleosis. J Clin Virol. 2007 May;39(1):16-21. doi: 10.1016/j.jcv.2007.02.002. Epub 2007 Mar 21.

    PubMed 17369082

  • Rea TD, Russo JE, Katon W, Ashley RL, Buchwald DS. Prospective study of the natural history of infectious mononucleosis caused by Epstein-Barr virus. J Am Board Fam Pract. 2001 Jul-Aug;14(4):234-42.

    PubMed 11458965

  • Cameron B, Galbraith S, Zhang Y, Davenport T, Vollmer-Conna U, Wakefield D, Hickie I, Dunsmuir W, Whistler T, Vernon S, Reeves WC, Lloyd AR; Dubbo Infection Outcomes Study. Gene expression correlates of postinfective fatigue syndrome after infectious mononucleosis. J Infect Dis. 2007 Jul 1;196(1):56-66. doi: 10.1086/518614. Epub 2007 May 24.

    PubMed 17538884

  • Torre D, Tambini R. Acyclovir for treatment of infectious mononucleosis: a meta-analysis. Scand J Infect Dis. 1999;31(6):543-7. doi: 10.1080/00365549950164409.

    PubMed 10680982

  • Silins SL, Sherritt MA, Silleri JM, Cross SM, Elliott SL, Bharadwaj M, Le TT, Morrison LE, Khanna R, Moss DJ, Suhrbier A, Misko IS. Asymptomatic primary Epstein-Barr virus infection occurs in the absence of blood T-cell repertoire perturbations despite high levels of systemic viral load. Blood. 2001 Dec 15;98(13):3739-44. doi: 10.1182/blood.v98.13.3739.

    PubMed 11739180

  • Hislop AD, Taylor GS, Sauce D, Rickinson AB. Cellular responses to viral infection in humans: lessons from Epstein-Barr virus. Annu Rev Immunol. 2007;25:587-617. doi: 10.1146/annurev.immunol.25.022106.141553.

    PubMed 17378764

  • Hislop AD, Kuo M, Drake-Lee AB, Akbar AN, Bergler W, Hammerschmitt N, Khan N, Palendira U, Leese AM, Timms JM, Bell AI, Buckley CD, Rickinson AB. Tonsillar homing of Epstein-Barr virus-specific CD8+ T cells and the virus-host balance. J Clin Invest. 2005 Sep;115(9):2546-55. doi: 10.1172/JCI24810. Epub 2005 Aug 18.

    PubMed 16110323

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Valomaciclovir 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 10 inclusion and 7 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 22 Mar 2017. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 17 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline (time frame: 21 days). 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 NCT00575185, which also lists 8 linked publications.

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 22 Mar 2017.

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