Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy (CYTOVEDO)

  • End date
    Apr 22, 2025
  • participants needed
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 22 April 2022


Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo.

CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC).

Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p<0.05).


The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation ; not responding to anti-TNF or without anti-TNF ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.

Condition Ulcerative Colitis, Unspecified
Treatment Valganciclovir
Clinical Study IdentifierNCT04064697
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on22 April 2022


Yes No Not Sure

Inclusion Criteria

Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo score greater than 5
Patient with an inflammatory outbreak of Ulcerative Colitis (UC)
without anti-TNF
under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure)
Having rectosigmoidoscopy with an endoscopic Mayo score≥ 2 with 2 biopsies of the
inflammatory tissue
Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral load greater than 5 IU / 100000 cells by qPCR)
Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCV serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by Rifinah or Rimifon
Signed informed consent

Exclusion Criteria

Patient with severe acute colitis
Patient treated by ciclosporin or Prograf
Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C, tuberculosis
Clostridium difficile infection
Patient with intolerance or contraindications to current therapy
Pregnant or starts breastfeeding
Patient who received a live vaccine in the month preceding the study
Patients with severe renal insufficiency defined by creatinine clearance <30ml/minute, or hemodialysed
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