Epstein Barr virus infection in people with multiple sclerosis. MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: LLT Classification code 10014077 Term: EBV infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Famciclovir
Product Name: Famciclovir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Famciclovir
CAS Number: 104227-87-4
Other descriptive name: 2-(2-(2-Amino-9H-purin-9-yl)e
Sponsors
Queen Mary University London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with MS aged over 18 who are taking Natalizumab (Tysabri) will be eligible for inclusion in this study. Participants must be able to provide informed consent to take part in this study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: People with MS who are taking interferon-beta preparations or teriflunomide will not be eligible for this study. People taking fingolimod, cladribine, alemtuzumab or ocrelizumab will be excluded. People with MS who are on additional immunomodulatory agents (either for MS treatment or other reasons) will not be eligible to take part in this study. Participants will be excluded if they have had a course of steroids within 3 months of study entry. People who are already taking antiviral or antiretroviral medication for any reason will be excluded from this study. People known to be allergic to penciclovir, acyclovir, valaciclovir or famciclovir will be excluded from the study. People taking probenecid will be excluded. People with significant renal (CKD 3 or 4) and/or liver impairment will not be eligible to take part in this study. People who are pregnant or breastfeeding will be excluded from this study, and those who are planning to become pregnant or unwilling to take precautions to prevent pregnancy will not be eligible to take part. People who are unable to provide informed consent for any reason will not be eligible to enter this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of this study is to explore the effect of famciclovir (500mg twice daily) on Epstein Barr virus shedding in the saliva of people with MS. ;Secondary Objective: An exploratory aim is to explore the effect of famciclovir (500mg twice daily) on serological markers of Epstein Barr virus (EBV) infection and evidence of the virus in blood. ;Primary end point(s): The primary outcome of this study will be suppression of EBV shedding in saliva. Shedding is defined as EBV DNA levels in saliva >5.8 copies/ml. ;Timepoint(s) of evaluation of this end point: Weekly saliva samples will be taken. We have previously demonstrated that there is significant variability in EBV shedding in saliva in people with MS over time. The endpoint will therefore be determined throughout the time that the participants are taking famciclovir (12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There are no secondary endpoints for this study. All other endpoints are exploratory. ;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
United Kingdom
Outcome results
None listed