A randomised controlled trial of Imiquimod cream vs. podophyllotoxin in combination with quadrivalent HPV or control vaccination in the treatment and prevention of recurrence of anogenital warts
The HIPvac Trial aims to compare the efficacy of imiquimod cream versus podophyllotoxin cream for the treatment of external anogenital warts, and determine if the addition of quadrivalent HPV vaccine affects either the clearance or recurrence rate.
It is a randomised, controlled, partially blinded 2 x 2 factorial trial. Participants were simultaneously randomised to one of two topical treatments, and vaccine or placebo. The four groups, therefore, are:
A. imiquimod cream plus HPV vaccine;
B. podophyllotoxin cream plus HPV vaccine;
C. imiquimod cream plus saline placebo injection.
D. podophyllotoxin cream plus saline placebo injection
The primary outcome is a composite endpoint of wart clearance within 16 weeks of starting treatment and remaining wart-free between 16 and 48 weeks. This will capture both the initial clearance efficacy as well as the impact on relapse or recurrence.
The trial was set-up in 22 centres across the UK and recruited 504 participants. Recruitment and follow-up is now complete and the trial is in analysis phase.