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Trial record 20 of 3966 for:    Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV)

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ClinicalTrials.gov Identifier: NCT02354144
Recruitment Status : Recruiting
First Posted : February 3, 2015
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Dr. Eduardo Franco, McGill University

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).

Condition or disease Intervention/treatment Phase
Human Papillomavirus Infection Other: Carrageenan-based gel Other: Control gel Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : February 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Carrageenan-based gel

The intervention to be administered is:

  • a commercially available gel that contains carrageenan.
  • water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the placebo gel.
  • also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.
Other: Carrageenan-based gel
Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.

Placebo Comparator: Control gel

The intervention to be administered is:

  • a commercially available gel that does not contain carrageenan.
  • water-based, latex-condom compatible, clear, odourless, tasteless, and have similar viscosity as the carrageenan-containing gel.
  • also packaged in a similar plastic bottle with a disk cap that can be operated with one finger, and must be applied prior to anal intercourse during the entire study period. Around 15 ml of the personal lubricant will be dispensed into the hand and applied directly to the genital, anal, and condom surfaces prior to and as needed during anal sex. When sexual activity ceases, the water-based formulation of the gel allows it to be easily removed with lukewarm water.
Other: Control gel
A gel not containing carrageenan




Primary Outcome Measures :
  1. 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 36 different HPV types will allow for the assessment of new HPV types even among those already infected.


Secondary Outcome Measures :
  1. Clearance of anal type-specific HPV infections found at baseline [ Time Frame: One year follow-up ]
  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged 18 or older,
  • Men living in Montreal and plan to remain in the city for the next 12 months,
  • Men who have had receptive anal sex with one or more men during the previous 3 months and intend to continue being sexually active for the duration of their involvement in the study, irrespective of whether their sexual partner will change,
  • Men planing on having receptive anal sex with one or more men, but less than 50 DIFFERENT partners per year
  • Men who understands French or English,
  • Men willing to follow study instructions and comply with follow-ups for 12 months.

Exclusion Criteria:

  • Men must not be receiving treatment for anal or perianal condylomas or anal intraepithelial neoplasia lesions during the trial,
  • Men must not have a known allergy or hypersensitivity to any of the ingredients in either gels.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354144


Contacts
Contact: Mariam El-Zein, PhD 514-398-1489 mariam.elzein@mcgill.ca
Contact: Allita Rodrigues, B.Sc. 514-398-8191 allita.rodrigues@mcgill.ca

Locations
Canada, Quebec
McGill University - Division of Cancer Epidemiology Recruiting
Montreal, Quebec, Canada, H4A 3T2
Contact: Allita Rodrigues    514-398-8191    allita.rodrigues@mcgill.ca   
Contact: Anna Tzagourni    (514) 398-8014    canepiadm.med@mcgill.ca   
Principal Investigator: Eduardo L Franco, DrPH         
Sponsors and Collaborators
McGill University
Université de Montréal
Investigators
Principal Investigator: Eduardo Franco, DrPH McGill University

Responsible Party: Dr. Eduardo Franco, James McGill Professor and Chair (Department of Oncology) and Director (Division of Cancer Epidemiology), McGill University
ClinicalTrials.gov Identifier: NCT02354144     History of Changes
Other Study ID Numbers: A10-M98-14B
CIHR-MOP-137066 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
CCSRI-703032 ( Other Grant/Funding Number: Canadian Cancer Society Research Institute )
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

Keywords provided by Dr. Eduardo Franco, McGill University:
Human papillomavirus
Carrageenan
Microbicide
Anal HPV infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections