None listed
Conditions
Brief summary
Gay and other men who have sex with men (MSM) with HIV infection have the highest rates of anal cancer. The HPV vaccine is not beneficial for adult MSM with HIV who already have high risk HPV types. As treatment for the precursor to anal cancer (anal intraepithelial neoplasia, or AIN) is both invasive and inefficient, a method of clearing anal HPV before it progresses to AIN is needed for MSM with HIV. The aim of this pilot study is to determine the proportion of MSM with HIV and high risk types of HPV that can tolerate 5% imiquimod cream three times a week for 16 weeks followed by weekly imiquimod cream for 12 months. The secondary aim is to determine the proportion of individuals with HIV and high risk types of HPV who agree to be part of the trial. We will recruit MSM who have HIV from Melbourne Sexual Health Centre when they present to clinic for routine care. Consenting men will be tested for high risk types of HPV in the anus and only those with at least one high risk type will be eligible. Eligible men will receive the HPV vaccine and imiquimod treatment for 3x/week application for 4 months followed by 1 year of 1x/week application. We expect MSM with HIV and high risk HPV will tolerate this treatment and it will clear HPV.
Interventions
This trial will ask men who have sex with men with HIV and a high risk type of HPV in the anus to apply (topically) Imiquimod (5% imiquimod) in and around the anus for 16 weeks (three times a week) followed by a 52 week maintenance program (weekly). Each dose of imiquimod will be half of a 250mg sachet (i.e. 125mg containing 6.25mg of imiquimod per dose). Participants will be asked to return questionnaires at consistent intervals that ask about their adherence to treatment as well as about any s
This trial will ask men who have sex with men with HIV and a high risk type of HPV in the anus to apply (topically) Imiquimod (5% imiquimod) in and around the anus for 16 weeks (three times a week) followed by a 52 week maintenance program (weekly). Each dose of imiquimod will be half of a 250mg sachet (i.e. 125mg containing 6.25mg of imiquimod per dose). Participants will be asked to return questionnaires at consistent intervals that ask about their adherence to treatment as well as about any side effects they may be experiencing. Upon recruitment (following a positive HPV test) participants will be offered the HPV vaccine if they have not already had one. This will be the quadrivalent HPV vaccine and will be given via injection from a clinician following the recommended schedule.
Sponsors
The Alfred
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
a) Men who have sex with men and are between 18 and 85 years of age b) Known HIV positive c) Tested positive for any high risk HPV type(16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and/or 68) at day of recruitment d) Sufficient English language proficiency to understand the requirements of the study and complete the questionnaire e) Provision of written informed consent
Exclusion criteria
a) Men who tested negative for all high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) at day of recruitment b) Men who are unable to attend the scheduled week 8 and week 16 visits c) Men who have been diagnosed with anal cancer in the last 12 months d) Men who have an organ transplant or an autoimmune disorder requiring any systemic treatment e) Transgender individuals
Outcome results
None listed