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HIPvac

1 November 2018

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. The research is funded by NIHR HTA.

It is a randomised, controlled partially blinded 2 x 2 factorial trial. Participants will be 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. HIPvac is now closed.

Publications

  • Gilson R, Nugent D,听Bennett K, Dor茅 CJ, Murray ML, Meadows J, Haddow L J, Lacey C, Sandmann F, Jit M, Soldan K,听Tetlow M, Caverly E, Nathan M, Copas A J.听. Health Technology Assessment 2020;24(47)

  • Gilson R, Bennett K, Sandmann F, Murray M, Dor茅 CJ, Haddow L, Nugent D, Lacey C, Jit M, Soldan K, Caverly E, Nathan M, Copas A.听. (Abstract) Sexually Transmitted Diseases 2019;95(Suppl 1), A50-A51.

  • Murray ML, Meadows J, Dor茅 CJ, Copas AJ, Haddow LJ, Lacey C, Jit M, Soldan K,听Bennett K, Tetlow M, Nathan M, Gilson R.听. BMC Medical Research Methodology 2018;18:125.

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ISRCTN32729817