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Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (Mono6)

This study has been completed.
Sponsor:
Collaborator:
Epiphany Biosciences
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00575185
First received: December 14, 2007
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Infectious Mononucleosis
Drug: Valomaciclovir
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine if treatment with valomaciclovir will significantly improve the clinical symptoms and reduce the viral burden in immunocompetent subjects with IM due to primary EBV infection. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the safety and tolerability of valomaciclovir. [ Time Frame: 15 ] [ Designated as safety issue: Yes ]

Enrollment: 23
Study Start Date: November 2007
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Valomaciclovir
Valomaciclovir 2 grams orally twice daily for 21 days
Drug: Valomaciclovir
4 grams orally of valomaciclovir (2 grams BID) for 21 days.
Placebo Comparator: placebo
placebo 2 tablets twice daily for 21 days
Drug: placebo
Placebo tablets orally twice daily for 21 days.

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575185

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Epiphany Biosciences
Investigators
Principal Investigator: Henry H Balfour, MD Professor of Laboratory Medicine & Pathology, and Pediatrics
  More Information

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00575185     History of Changes
Other Study ID Numbers: 0709M16341
Study First Received: December 14, 2007
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Mono
Mononucleosis
Epstein-Barr virus

Additional relevant MeSH terms:
Infectious Mononucleosis
Communicable Diseases
Epstein-Barr Virus Infections
Infection
Virus Diseases
DNA Virus Infections
Hematologic Diseases
Herpesviridae Infections
Immune System Diseases
Immunoproliferative Disorders
Leukocyte Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms, Experimental
Tumor Virus Infections

ClinicalTrials.gov processed this record on November 20, 2014