The 2VAL Study: A trial comparing the effect of valacyclovir and valganciclovir prophylaxis against cytomegalovirus (CMV) infection after renal transplantation

Randomized trial comparing valacyclovir versus valganciclovir prophylaxis of cytomegalovirus infection in renal transplant recipients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000016033

Acronym

The 2VAL Study

Enrollment

119

Registered

2007-09-26

Start date

2007-11-17

Completion date

2012-04-25

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are two major hypothesis to test: 1) Valacyclovir prophylaxis for cytomegalovirus infection is not inferior than valganciclovir prophylaxis in the prevention of active cytomegalovirus infection and disease. 2) Valacyclovir is superior to valganciclovir in the prevention of indirect effects of cytomegalovirus: acute renal allograft rejection in short term follow up, and renal function and chronic interstitial fibrosis and tubular atrophy (IF/TA) in long-term follow up.

Interventions

Oral valacyclovir (VALTREX, Glaxo Wellcome) 8g/day for 3 months after transplantation started within 1 week post transplant

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Recipients of transplant from deceased or living donor, known donor (D) and recipient (R) CMV serology before transplantation of D+/R- or D+/R+ or D-/R+, provided informed consent

Exclusion criteria

Unknown or D-/R- CMV serology prior to transplantation, systemic antiviral drug intake within 2 weeks before transplantation except for hepatitis B therapy (lamivudine, adefovir, entecavir), active viral infection at the time of transplantation (except for hepatitis B or C), significant leukopenia or thrombocytopenia, participation in another clinical trial, known allergy to (val)acyclovir or (val)ganciclovir, inability to provide informed concent

Outcome results