Does cytomegalovirus affect the function of the body’s immune cells? The potential for anti-viral treatment to prevent the negative effects of cytomegalovirus on the immune system in patients with vasculitis

• Conditions: This study will investigate the modulation of the immune system by Cytomegalovirus (CMV) in ANCA-associated vasculitis. Specifically the study will investigate the potential for valaciclovir to prevent CMV-mediated adverse modulation of the immune system in patients with ANCA-associated vasculitis.; MedDRA version: 15.0Level: PTClassification code 10011831Term: Cytomegalovirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 15.0Level: PTClassification code 10050894Term: Anti-neutrophil cytoplasmic antibody positive vasculitisSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-001970-28-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-10
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Documented diagnosis of ANCA associated vasculitis
•In stable remission (no documented clinical disease activity) for at least 6 months prior to entry.
•On maintenance immunosuppression with maximum 2 agents.
•Documented evidence of CMV infection.
•Documentation that female patients of child bearing age are not pregnant.
•Written informed consent for study participation

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

•Severe chronic kidney disease (Stage 5).
•Other significant chronic infection (HIV, HBV, HCV, TB).
•B-cell or T-cell depleting therapy within 12 months.
•Treatment with anti-CMV therapies in last month
•Underlying medical conditions, which in the opinion of the Investigator place the patient at unacceptably high risk for participating in the study.
•Inability to fully or appropriately participate in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified