Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to determine: a) whether those patients with 'low level' viral load results (between 200 and 3,000 copies/ml) could be monitored as opposed to starting preemptive therapy with valganciclovir, ganciclovir and/or foscarnet; b) whether those patients with 'high level' viral load results (above 3,000 copies/ml) could stop preemptive therapy earlier, thus maximising the benefits of therapy and minimising its risks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College, London
• Treatments: Foscarnet; Ganciclovir; Ganciclovir triphosphate; Phosphonoacetic Acid; Valganciclovir

Criteria

Inclusion Criteria:

1. All Stem Cell, Renal and Liver Transplant recipients.

2. Willing to give informed consent.

3. For Group A) All patients with CMV viraemia (between 200 and 3000 copies/ml) in the liver, renal and stem cell groups in two consecutive samples & for Group B) Those patients requiring pre-emptive therapy because viral load is > 3,000 copies/ml.

4. All patients in either section of the study must be available for CMV PCR monitoring at least twice per week.

Exclusion Criteria:

1. Exclusion Criteria

2. Profound neutropaenia considered to preclude administration of ganciclovir or profound renal failure considered to preclude administration of foscarnet.

3. Inability to give informed consent.

4. In the stem cell group, Donor negative, Recipient negative transplants.

5. In the stem cell group: matched unrelated donors who are CMV seronegative.

6. Those patients who have been in Group A cannot then enter the Group B part. of the study. 5.2.6 Those patients who have been in Group B cannot then enter the Group A part of the study.