MICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

April 2, 2009 updated by: University Hospital, Grenoble

Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The cytomegalovirus (CMV) is a DNA virus from the herpes virus family. It is passed on between humans and even if infection is widespread (50 to 80% of people older than 35 are CMV immunoglobulin G positive) it is often asymptomatic for immunocompetent people. However, for immunocompromised people, such an infection takes on particular frequency, expression and seriousness, with a high frequency of attack to the digestive track (CMV colitis).

For immunocompetent people, colitis causes feverish bloody diarrhea associated with abdominal pain. Colitis diagnosis is often late and cases with complications have been reported (digestive bleeding, toxic giant colon and perforation). The endoscopic aspect of colitis is not specific and diagnosis is based on serology, anatomopathology or immunochemistry. Recently, PCR approaches have allowed more sensitive diagnosis.

CMV INVOLVEMENT IN CIBD PHYSIOPATHOLOGY:

Even though CMV involvement in colitis is rare but sure for immunocompetent people, its involvement in CIBD triggering and morbidity has not been solved yet.

Some authors think infection by CMV may act on CIBD as a trigger factor; since 2 cases of CMV colitis coinciding with the onset of a CIBD have been reported. For other authors, infection by CMV acts by direct pathogenicity causing ulcerative lesions of colonic mucosa and just imitates a CIBD without triggering it.

A third hypothesis is that infection by CMV aggravates inflammatory bowel diseases acting as an exacerbating factor.

In all cases, people suffering from CIBD are highly-exposed to infection by CMV due to immunosuppressive treatment (corticoids, cyclosporine, azathioprin, and methotrexate) and the inflammation itself (which is supposed to be a proning factor).

CMV AND POUCHITIS:

Pouchitis is the most common long-term complication after total proctocolectomy. Usually, it can be cured by antibiotic therapy, but in 15% of cases it becomes chronic and turns onto refractory pouchitis which is difficult to cure.

Infection by CMV can imitate a chronic pouchitis from a clinical and endoscopic view. In such cases, it had been shown that Valganciclovir treatment (10mg/kg/day) led to significant improvement over a 21 day treatment period.

CONCLUSION:

Infection by CMV seems to play an important role and has to be taken into account in CIBD physiopathogeny. Probably underestimated since it is not necessarily searched, it could be a triggering factor or a treatment resistance factor. Immunosuppressive drugs used towards recurrent bouts, in particularly cyclosporine, favors viral reactivation. Then, recurrent bouts of CIBD may be complicated by CMV infection. That is why it could be interesting to establish relevance of antiviral treatment on recurrent bouts of CIBD with infection by CMV.

The main objective of this study is to demonstrate relevance of Valganciclovir on recurrent bouts of Cryptogenic Inflammatory Bowel Diseases with infection by Cytomegalovirus. The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) of remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

Secondary objectives are:

  • Reversal of CMV immunoglobulin G serology and PCR results on colonic biopsies.
  • Improvement in appearance of histological lesions
  • Reduction in the number of colectomies
  • Evaluation of Valganciclovir tolerance and its side effects

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Gastroenterology Department - University Hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient suffering from Crohn's disease, ulcerative colitis, unclassifiable colitis or pouchitis.
  • Disease needing to be treated by corticoids and/or immunosuppressive drugs.
  • Infection by cytomegalovirus.
  • New attack during the three previous months.

Exclusion Criteria:

  • Serious or complicated attack, needing to be operated.
  • Patient suffering from a psychiatric disease or is uncooperative.
  • Patient suffering from another serious disease.
  • Patient already participating in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of Crohns disease activity index score
Diminution or disappearance of gravity criteria
Endoscopy: improvement in appearance of lesions, or healing
Anatomopathology: improvement of histological criteria, or total regression
Anatomopathology: disappearance of viral infection criteria
Virology: reversal of CMV IgG serology and PCR results

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Bruno BONAZ, MD, Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 11, 2005

First Submitted That Met QC Criteria

October 11, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

April 3, 2009

Last Update Submitted That Met QC Criteria

April 2, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 03 21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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