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CMV Modulation of the Immune System in ANCA-associated Vasculitis

NCT01633476 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-11-30

No results posted yet for this study

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.

Conditions

  • ANCA Associated Vasculitis
  • CMV Infection

Interventions

DRUG

Valaciclovir

2g q.d.s. orally for 6 months (dose adjusted according to renal function)

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Professor Lorraine Harper

    lead OTHER

Principal Investigators

  • Lorraine Harper, MRCP PhD · University of Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2016-02-29
Completion
2017-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01633476 on ClinicalTrials.gov