Lubricant Investigation in Men to Inhibit Transmission of HPV Infection

NCT02354144 | Terminated Phase 2 Results

• 3 other identifiers: A10-M98-14BCIHR-MOP-137066CCSRI-703032
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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 enrollment 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 events. Individuals will be screened for eligibility over the telephone or in person and eligible men will attend an enrollment 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 (enrollment/time 0), and at all follow-up clinic visits (1, 2, 3, 6, 9 and 12 months).

Conditions

Human Papillomavirus Infection

Keywords

Human papillomavirus; Carrageenan; Microbicide; Anal HPV infection

Outcome Measures

Primary Outcomes (1)

• Presence of a Newly Detected Anal Infection of a Specific HPV Type in a Man Who Was Negative for That HPV Type at Enrollment

  Detection of 36 different HPV types will allow for the assessment of new HPV types even among those already infected.

  One year follow-up

Secondary Outcomes (2)

• Clearance of Anal Type-specific HPV Infections Found at Baseline

  One year follow-up

• Patient Adherence, Measured Via Questionnaires and Review of Patient Adverse Event Reports.

  One year follow-up

Study Arms (2)

Carrageenan-based gel

EXPERIMENTAL

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

Control gel

PLACEBO COMPARATOR

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

Interventions

Carrageenan-based gel OTHER

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.

Carrageenan-based gel

Control gel OTHER

A gel not containing carrageenan

Control gel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 planning on having receptive anal sex with two 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead
• Université de Montréal: collaborator

Study Sites (1)

McGill University - Division of Cancer Epidemiology

Montreal, Quebec, H4A 3T2, Canada

Location

Related Publications (4)

• Kassam P, El-Zein M, Tota JE, Tellier PP, Coutlee F, de Pokomandy A, Franco EL. HPV vaccination and anal HPV infection in gay, bisexual, and other men who have sex with men. Vaccine. 2025 Jan 25;45:126644. doi: 10.1016/j.vaccine.2024.126644. Epub 2024 Dec 21.

  PMID: 39708517 DERIVED

• Laurie C, El-Zein M, Tota J, Khosrow-Khavar F, Tellier PP, Coutlee F, de Pokomandy A, Franco EL; Lubricant Investigation in Men to Inhibit Transmission of Human Papillomavirus Infection (LIMIT-HPV) Study Group. Efficacy of a Carrageenan Gel in Increasing Clearance of Anal Human Papillomavirus Infections in Men: Interim Analysis of a Double-Blind, Randomized Controlled Trial. J Infect Dis. 2023 Feb 1;227(3):402-406. doi: 10.1093/infdis/jiac019.

  PMID: 35090175 DERIVED

• Laurie C, El-Zein M, Tota JE, Khosrow-Khavar F, Tellier PP, Coutlee F, de Pokomandy A, Franco EL; LIMIT-HPV study group. Efficacy of a carrageenan gel in preventing anal human papillomavirus (HPV) infection: interim analysis of the Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV) randomised controlled trial. Sex Transm Infect. 2022 Jun;98(4):239-246. doi: 10.1136/sextrans-2021-055009. Epub 2021 Jun 17.

  PMID: 34140405 DERIVED

• Laurie C, El-Zein M, Tota J, Tellier PP, Coutlee F, Franco EL, de Pokomandy A; LIMIT-HPV study group. Lubricant Investigation in Men to Inhibit Transmission of HPV Infection (LIMIT-HPV): design and methods for a randomised controlled trial. BMJ Open. 2020 Mar 23;10(3):e035113. doi: 10.1136/bmjopen-2019-035113.

  PMID: 32205376 DERIVED

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Eduardo Franco
• Organization: Division of Cancer Epidemiology, Department of Oncology, McGill University

eduardo.franco@mcgill.ca

514-398-6032

Study Officials

• Eduardo Franco, DrPH

  McGill University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James McGill Professor and Chair (Department of Oncology) and Director (Division of Cancer Epidemiology)

Model Details: Carrageenan-containing gel

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: February 1, 2016
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: June 15, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-05

Locations

CA (1)