Human papillomavirus infection: 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)
University College London
The HIPvac trial will address two questions regarding the management of patients with genital warts. The first is which of the two most frequently used creams used to treat warts, imiquimod or podophyllotoxin, is most effective at clearing genital warts, and preventing recurrence. The second is whether a course of human papillomavirus (HPV) vaccine started at the time of initiating topical treatment, increases the effectiveness of the cream in either clearing the warts or preventing recurrence. The HPV vaccine used is licensed for the prevention of infection caused by HPV 6 and 11 (which cause 90% genital warts) and HPV 16 and 18 (cause 70% cervical cancer). The vaccine is used in the national vaccination programme in the UK for girls aged 12-13; it is not licensed for the treatment of genital warts.
Entry criteria: patients with genital warts, either first episode or as a recurrence/new episode; no treatment for genital warts in the last three months, not pregnant or HIV positive.
The trial will follow participants for 48 weeks (6 visits). They will be randomly assigned to one of the creams (imiquimod or podophyllotoxin). Patients will know which cream they have been given as the creams have different dosing schedules. The creams will be used per standard care. The vaccine will be randomly assigned at the same time in a double blind fashion; neither the patient nor their doctor will know which vaccine they receive. Participants will receive either HPV vaccine (Gardasil), an active control (hepatitis A vaccine) or placebo (saline injection) in a 2:1:1 ratio. Patients will receive three doses of vaccine, the first at their baseline visit, then at week 8 and 24. The primary outcome measure of the study is the proportion of patients with clearance of warts at 16 weeks who remain clear at 48 weeks.
South Central - Oxford B Research Ethics Committee
Date of REC Opinion
3 Feb 2014
Further Information Favourable Opinion