Journal Article

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)

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

2018

Overview

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).

• Publisher: BioMed Central,Springer Nature B.V,BMC
• Subject: Adult / Anogenital warts / Antiviral drugs / Cryotherapy / Disease prevention / Drug Therapy, Combination / Evidence-based medicine / Female / Health Sciences / Health services / Hepatitis / HIV / Host-Pathogen Interactions - drug effects / Host-Pathogen Interactions - immunology / Human immunodeficiency virus / Human papillomavirus / Humans / Imiquimod / Imiquimod - therapeutic use / Infections / Male / Medicine / Medicine & Public Health / Papillomaviridae - drug effects / Papillomaviridae - immunology / Papillomaviridae - physiology / Papillomavirus Infections - drug therapy / Papillomavirus Infections - prevention & control / Papillomavirus Infections - virology / Papillomavirus Vaccines - immunology / Papillomavirus Vaccines - therapeutic use / Podophyllotoxin / Podophyllotoxin - therapeutic use / Quadrivalent HPV vaccine / Recurrence / Statistical Theory and Methods / Statistics for Life Sciences / Study design / Study Protocol / Systematic review / Theory of Medicine/Bioethics / Treatment Outcome / Vaccination / Vaccines