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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2018

Open Access 01-12-2018 | Study protocol

Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)

Authors: Macey L. Murray, Jade Meadows, Caroline J. Doré, Andrew J. Copas, Lewis J. Haddow, Charles Lacey, Mark Jit, Kate Soldan, Kate Bennett, Michelle Tetlow, Mayura Nathan, Richard Gilson

Published in: BMC Medical Research Methodology | Issue 1/2018

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Abstract

Background

Anogenital warts are the second most common sexually transmitted infection diagnosed in sexual health services in England. About 90% of genital warts are caused by human papillomavirus (HPV) types 6 or 11, and half of episodes diagnosed are recurrences. The best and most cost-effective treatment for patients with anogenital warts is unknown. The commonly used treatments are self-administered topical agents, podophyllotoxin (0.15% cream) or imiquimod (5% cream), or cryotherapy with liquid nitrogen. Quadrivalent HPV (qHPV) vaccination is effective in preventing infection, and disease, but whether it has any therapeutic effect is not known.

Methods and design

To investigate the efficacy of clearance and prevention of recurrence of external anogenital warts by topical treatments, podophyllotoxin 0.15% cream or imiquimod 5% cream, in combination with a three-dose regimen of qHPV or control vaccination. 500 adult patients presenting with external anogenital warts with either a first or subsequent episode of anogenital warts will be entered into this randomised, controlled partially blinded 2 × 2 factorial trial.

Discussion

The trial is expected to provide the first high-quality evidence of the comparative efficacy and cost-effectiveness of the two topical treatments in current use, as well as investigate the potential benefit of HPV vaccination, in the management of anogenital warts.

Trial registration

The trial was registered prior to starting recruitment under the following reference numbers: International Standard Randomized Controlled Trial Number (ISRCTN) Registry - ISRCTN32729817 (registered 25 July 2014); European Union Clinical Trials Register (EudraCT) - 2013-002951-14 (registered 26 June 2013).
Appendix
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Metadata
Title
Human papillomavirus infection: protocol for a randomised controlled trial of imiquimod cream (5%) versus podophyllotoxin cream (0.15%), in combination with quadrivalent human papillomavirus or control vaccination in the treatment and prevention of recurrence of anogenital warts (HIPvac trial)
Authors
Macey L. Murray
Jade Meadows
Caroline J. Doré
Andrew J. Copas
Lewis J. Haddow
Charles Lacey
Mark Jit
Kate Soldan
Kate Bennett
Michelle Tetlow
Mayura Nathan
Richard Gilson
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2018
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-018-0581-z

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