CMV Modulation of the Immune System in ANCA-associated Vasculitis

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Cytomegalovirus (CMV) reactivation in ANCA-associated vasculitis (AAV) patients can be effectively and safely reduced using an antiviral agent (valaciclovir) and whether this in turn improves the function of the immune system thereby also improving the body's ability to fight other infections.

The primary hypothesis is that repeated episodes of CMV reactivation in AAV patients drive the expansion and functional impairment of CMV-specific T-cells, with increased susceptibility to infection. Inhibition of CMV replication with valaciclovir will block further stimulation of CMV specific T-cells and increase the functional capacity of the immune system.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Lorraine Harper
• Collaborator: Wellcome Trust
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• Documented diagnosis of Wegener's granulomatosis (now called Granulomatosis with Polyangiitis), microscopic polyangiitis or renal limited vasculitis according to Chapel Hill Consensus Conference criteria.

• In stable remission (no documented clinical disease activity) for at least 6 months prior to entry.

• On maintenance immunosuppression with prednisolone, mycophenolate mofetil or azathioprine alone or in combination (maximum 2 agents).

• Documented evidence of CMV infection (CMV-specific immunoglobulin G detected in peripheral blood).

• Documentation that female patients of child bearing potential are not pregnant and using an appropriate form of contraception.

• Written informed consent for study participation

Exclusion Criteria:

• Stage 5 chronic kidney disease (eGFR<15ml/minute/1.73m2).

• 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.