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Trial registered on ANZCTR


Registration number
ACTRN12617001355369
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
27/09/2017
Date last updated
19/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
CHAMP: Clearing High Risk HPV Among Men who have sex with Men Pilot
Scientific title
A clinical trial looking at the tolerability and side effects of using imiquimod to treat anal HPV in men who have sex with men and are HIV positive
Secondary ID [1] 292859 0
nil known
Universal Trial Number (UTN)
U1111-1201-9524
Trial acronym
CHAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
human papillomavirus
304699 0
human immunodeficiency virus (HIV) 304760 0
Condition category
Condition code
Infection 304011 304011 0 0
Sexually transmitted infections
Infection 304083 304083 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 299100 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303485 0
The proportion of participants who can tolerate the intervention (defined as completing at least 50% of scheduled doses) as assessed by a survey specifically designed for this study on adherence to treatment
Timepoint [1] 303485 0
16 weeks
Primary outcome [2] 303486 0
Health-related quality of life as assessed via EQ5D
Timepoint [2] 303486 0
16 weeks
Primary outcome [3] 303487 0
Sexual functioning as assessed by the Sexual Functioning questionnaire
Timepoint [3] 303487 0
16 weeks
Secondary outcome [1] 338708 0
Proportion of men with anal high risk HPV re-infection upon assessment of anal swab sample by NAAT
Timepoint [1] 338708 0
16 weeks after intervention commencement
Secondary outcome [2] 338709 0
Proportion of men with anal high risk HPV re-infection upon assessment of anal swab sample by NAAT
Timepoint [2] 338709 0
At the end of 52 weeks maintenance period (68 weeks following intervention commencement).
Secondary outcome [3] 339058 0
All primary outcomes also assessed at 52 weeks (also primary outcome of the study)
Timepoint [3] 339058 0
52 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8978 0
The Alfred - Prahran
Recruitment postcode(s) [1] 17475 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 297490 0
Government body
Name [1] 297490 0
National Health and Medical Research Council
Address [1] 297490 0
16 Marcus Clarke Street, Canberra City, ACT 2600
Country [1] 297490 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 296497 0
Individual
Name [1] 296497 0
Prof Christopher Fairley
Address [1] 296497 0
Melbourne Sexual Health Centre, 580 Swanston Street, Carlton Vic 3052
Country [1] 296497 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298591 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 298591 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 298591 0
Australia
Date submitted for ethics approval [1] 298591 0
25/09/2017
Approval date [1] 298591 0
28/11/2017
Ethics approval number [1] 298591 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77586 0
Prof Christopher Fairley
Address 77586 0
Melbourne Sexual Health Centre, 580 Swanston Street, Carlton VIC 3052
Country 77586 0
Australia
Phone 77586 0
+61 3 9341 6236
Fax 77586 0
Email 77586 0
CFairley@mshc.org.au
Contact person for public queries
Name 77587 0
Dr Eric Chow
Address 77587 0
Melbourne Sexual Health Centre, 580 Swanston Street, Carlton VIC 3052
Country 77587 0
Australia
Phone 77587 0
+61 3 9341 6233
Fax 77587 0
Email 77587 0
EChow@mshc.org.au
Contact person for scientific queries
Name 77588 0
Dr Eric Chow
Address 77588 0
Melbourne Sexual Health Centre, 580 Swanston Street, Carlton VIC 3052
Country 77588 0
Australia
Phone 77588 0
+61 3 9341 6233
Fax 77588 0
Email 77588 0
EChow@mshc.org.au

No data has been provided for results reporting
Summary results
Not applicable