Clinical Trial: Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial of a Carrageenan-Containing Lubricant to Reduce Transmission of Human Papillomavirus Infection Among Men Who Have Sex With Men

Brief Summary: The LIMIT-Study is a placebo-controlled, double-blinded randomized controlled trial designed to explore the efficacy of a carrageenan-based lubricant as a topical microbicide for preventing HPV acquisition. Individuals at high risk for infection (men who have sex with men, or MSM, and especially those with HIV) will be included in the trial. Participants will complete a self-administered baseline questionnaire during the enrolment visit, and follow-up questionnaires during all other six visits. The shorter follow-up questionnaires are intended to evaluate recent sexual behaviours and to corroborate the responses given during the baseline visit. These questionnaires will measure HPV risk factors, compliance, and monitor safety and tolerability of the gels. Between follow-up visits, participants will be asked to log into a secure web module at least once a week to answer questions on daily sexual activities, condom and study gel use, and adverse evens. Individuals will be screened for eligibility over the telephone or in person and eligible men will attend an enrolment visit, where the nurse will obtain informed consent and instruct the participant on gel use. They will receive a one month's supply of gel and provide the first specimen. Random number sets will be assigned to the treatment and control gel. Each participant will be assigned an individual code, which will be used to match him to the study arm. Lastly, the nurse will provide details about HPV infection and advice about condom use and sexual health. HPV infection status will be measured using anal specimens at baseline (enrolment/time 0), and at all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).

Detailed Summary:

Human papillomavirus (HPV) inhibitory compounds might be useful as topical microbicides for blocking the spread of HPV. Recent in-vitro and in-vivo laboratory studies have demonstrated the strong inhibitory properties of carrageenan (an inexpensive gelling agent that is non-toxic and safe in animals and humans) against all HPV types. So far, there has been no clinical trial designed to assess a carrageenan-based personal lubricant as a topical microbicide in the Men who have Sex with Men (MSM) population. Since the introduction of HAART therapy in 1996, there has been a paradoxical effect on the incidence of anal cancer, a disease caused by HPV. Whereas patients would formerly die of some other AIDS-related ailment, men undergoing HAART therapy now have increased longevity, thus allowing diseases with longer natural history such as anal cancer to develop. Low CD4 counts, high HPV incidence and longer duration of infection have contributed to elevating the risk of anal lesions and cancer among MSMs with HIV to nearly 80 times that of the general male population. Although HPV vaccination has been approved for males in Canada, it is exclusively prophylactic, i.e. it will only prevent HPV infection before exposure occurs. But considering that most MSMs will have already been exposed to the vaccine target types, its benefits in this population are limited. Furthermore, current vaccination only protects against two of the 14 oncogenic HPV types.

The primary aim of the study is to evaluate the efficacy of carrageenan in reducing type-specific anal HPV incidence, i.e., in preventing infections by new HPV types in sexually active MSM. Secondary aims are: 1) to evaluate the efficacy of carrageenan in reducing type-specific anal HPV prevalence, i.e., in accelerating clearance of existing infections in sexually active MSM; 2) to compare the efficacy of carrageenan for type-specific p
Sponsor: McGill University

Current Primary Outcome: Presence of a newly detected anal infection of a specific HPV type in a man who was negative for that HPV type at enrolment [ Time Frame: One year follow-up ]

Detection of 37 different HPV types will allow for the assessment of new HPV types even among those already infected.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clearance of anal type-specific HPV infections found at baseline [ Time Frame: One year follow-up ]
  • Patient adherence, measured via questionnaires and review of patient adverse event reports. [ Time Frame: One year follow-up ]
    Measured via questionnaires and review of patient adverse event reports.


Original Secondary Outcome: Same as current

Information By: McGill University

Dates:
Date Received: January 29, 2015
Date Started: February 2016
Date Completion: December 2018
Last Updated: August 16, 2016
Last Verified: August 2016