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

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ClinicalTrials.gov Identifier: NCT02354144
Recruitment Status : Terminated (Mandated by DSMB)
First Posted : February 3, 2015
Results First Posted : June 15, 2021
Last Update Posted : June 15, 2021
Sponsor:
Collaborator:
Université de Montréal
Information provided by (Responsible Party):
Dr. Eduardo Franco, McGill University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Human Papillomavirus Infection
Interventions Other: Carrageenan-based gel
Other: Control gel
Enrollment 258
Recruitment Details  
Pre-assignment Details Recruitment for the LIMIT-HPV trial began in February 2016 at the following sites in Montreal, Canada: McGill University Health Centre, Clinique Médicale Urbaine du Quartier-Latin, Clinique OPUS, and two student health services clinics (McGill and Concordia universities). From September 2018 to March 2020, study visits were completed at McGill University's Division of Cancer Epidemiology's research clinic. 255 of the 258 participants were enrolled and analyzed at the time of interim analysis.
Arm/Group Title Carrageenan-based Gel Control Gel
Hide Arm/Group Description

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.

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.

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.

Control gel: A gel not containing carrageenan

Period Title: Overall Study
Started 127 128
Completed 48 [1] 51 [1]
Not Completed 79 77
[1]
Participants completed all 7 study visits.
Arm/Group Title Carrageenan-based Gel Control Gel Total
Hide Arm/Group Description

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.

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.

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.

Control gel: A gel not containing carrageenan

Total of all reporting groups
Overall Number of Baseline Participants 127 128 255
Hide Baseline Analysis Population Description
The description of baseline characteristics includes participants included in the interim analysis prior to trial termination.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 128 participants 255 participants
36.7  (14.2) 37.0  (14.4) 36.9  (14.3)
[1]
Measure Description: The description of baseline characteristics includes participants included in the interim analysis prior to trial termination.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 128 participants 255 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
127
 100.0%
128
 100.0%
255
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 128 participants 255 participants
French Canadian
48
  37.8%
50
  39.1%
98
  38.4%
English Canadian
17
  13.4%
20
  15.6%
37
  14.5%
Latin American
14
  11.0%
15
  11.7%
29
  11.4%
European
20
  15.7%
12
   9.4%
32
  12.5%
Other
28
  22.0%
31
  24.2%
59
  23.1%
Human immunodeficiency virus status, positive  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 128 participants 255 participants
33
  26.0%
35
  27.3%
68
  26.7%
HPV DNA status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 128 participants 255 participants
84
  66.1%
71
  55.5%
155
  60.8%
[1]
Measure Description: Anal samples were tested and typed for 36 different HPV types using the linear array assay from Roche. Participants were considered HPV positive if the anal sample was positive for any of the 36 different HPV types.
1.Primary Outcome
Title Presence of a Newly Detected Anal Infection of a Specific HPV Type in a Man Who Was Negative for That HPV Type at Enrollment
Hide Description Detection of 36 different HPV types will allow for the assessment of new HPV types even among those already infected.
Time Frame One year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
201 participants were included in the intention to treat analyses. Of the 255 initially randomized, 45 were excluded because they only had one visit and 9 were excluded because HPV data was unavailable.
Arm/Group Title Carrageenan-based Gel Control Gel
Hide Arm/Group Description:

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.

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.

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.

Control gel: A gel not containing carrageenan

Overall Number of Participants Analyzed 98 103
Measure Type: Count of Participants
Unit of Measure: Participants
68
  69.4%
67
  65.0%
2.Secondary Outcome
Title Clearance of Anal Type-specific HPV Infections Found at Baseline
Hide Description Detection of 36 different HPV types will allow for the assessment of clearance of any HPV type or specific HPV types.
Time Frame One year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 255 participants randomized at the time of interim analysis, there were 134 participants positive for HPV at baseline that had at least 2 visits with valid HPV results. These 134 participants were included in the clearance analyses.
Arm/Group Title Carrageenan-based Gel Control Gel
Hide Arm/Group Description:

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.

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.

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.

Control gel: A gel not containing carrageenan

Overall Number of Participants Analyzed 68 66
Measure Type: Count of Participants
Unit of Measure: Participants
19
  27.9%
22
  33.3%
3.Secondary Outcome
Title Patient Adherence, Measured Via Questionnaires and Review of Patient Adverse Event Reports.
Hide Description Measured via questionnaires and review of patient adverse event reports. Adherence was defined as the number of times the gel was used during receptive anal intercourse divided by the number of receptive anal intercourse in the 7 days preceding each visit. Participants were considered adherent at a particular visit if they used the gel during receptive anal intercourse ≥ 50% of the time. This variable was analyzed at the visit level. Safety analyses are included in the adverse event reporting section.
Time Frame One year follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 255 participants randomized at the time of interim analysis, 210 participants had available follow-up and were included in adherence and safety analyses.
Arm/Group Title Carrageenan-based Gel Control Gel
Hide Arm/Group Description:

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.

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.

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.

Control gel: A gel not containing carrageenan

Overall Number of Participants Analyzed 127 128
Overall Number of Units Analyzed
Type of Units Analyzed: Visits
428 441
Count of Units
Unit of Measure: visits
361
  84.3%
389
  88.2%
Time Frame Adverse event data was collected over the course of the participants follow-up (1 year).
Adverse Event Reporting Description Adverse event (AE) data was collected from the weekly calendar, follow-up surveys, and nurses notes. Data from the weekly calendar and nurses notes included specific descriptions of the AE. AE data from the follow-up surveys was a yes no answer to the question of whether the participant experience any adverse events or adverse reactions.
 
Arm/Group Title Carrageenan-based Gel Control Gel
Hide Arm/Group Description

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.

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.

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.

Control gel: A gel not containing carrageenan

All-Cause Mortality
Carrageenan-based Gel Control Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/102 (0.00%)      1/108 (0.93%)    
Hide Serious Adverse Events
Carrageenan-based Gel Control Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      1/108 (0.93%)    
Infections and infestations     
Death * [1]  0/102 (0.00%)  1/108 (0.93%) 
*
Indicates events were collected by non-systematic assessment
[1]
Death, related to underlying HIV infection complicated by drug use.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carrageenan-based Gel Control Gel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/102 (59.80%)      43/108 (39.81%)    
Product Issues     
Unusual pain during anal sex  [1]  4/75 (5.33%)  4 0/77 (0.00%)  0
Rectal bleeding in between anal sex  [1]  6/75 (8.00%)  6 0/77 (0.00%)  0
Unusual abdominal pain  [1]  2/75 (2.67%)  2 0/77 (0.00%)  0
Unusually painful defecation  [1]  0/75 (0.00%)  0 0/77 (0.00%)  0
Flatulence, constipation, urgency and/or fecal incontinence or diarrhea  [1]  0/75 (0.00%)  0 1/77 (1.30%)  1
Rectal abscess/ulcer/fistulae  [1]  0/75 (0.00%)  0 0/77 (0.00%)  0
Anal discharge  [1]  2/75 (2.67%)  2 0/77 (0.00%)  0
Hemorrhoids  [1]  0/75 (0.00%)  0 0/77 (0.00%)  0
Itching, burning, edema or pain in the anorectal area  [1]  4/75 (5.33%)  4 0/77 (0.00%)  0
Anal fissures  [1]  0/75 (0.00%)  0 0/77 (0.00%)  0
Other  [1]  3/75 (4.00%)  3 1/77 (1.30%)  1
Use of the gel caused discomfort/adverse reactions to you  [2]  18/99 (18.18%)  18 8/103 (7.77%)  8
Use of the gel caused discomfort/adverse reactions to your partner(s)  [2]  13/99 (13.13%)  13 2/105 (1.90%)  2
Reported bleeding following receptive anal intercourse  [3]  47/95 (49.47%)  47 43/101 (42.57%)  43
Warts * [4]  6/102 (5.88%)  6 7/108 (6.48%)  7
Erythema * [4]  6/102 (5.88%)  6 9/108 (8.33%)  9
Abrasions * [4]  4/102 (3.92%)  4 2/108 (1.85%)  2
Inflammation * [4]  2/102 (1.96%)  2 0/108 (0.00%)  0
Fissures * [4]  3/102 (2.94%)  3 2/108 (1.85%)  2
Abscesses * [4]  1/102 (0.98%)  1 1/108 (0.93%)  1
Hemorrhoids * [4]  11/102 (10.78%)  11 7/108 (6.48%)  7
Venereal warts or condylomas  [5]  2/95 (2.11%)  2 3/92 (3.26%)  3
Chlamydia  [6]  14/102 (13.73%)  14 12/108 (11.11%)  12
Lymphogranuloma vereneum  [6]  0/102 (0.00%)  0 1/108 (0.93%)  1
Anal or genital herpes  [6]  5/102 (4.90%)  5 5/108 (4.63%)  5
Syphilis  [6]  7/102 (6.86%)  7 7/108 (6.48%)  7
Gonorrhea  [6]  23/102 (22.55%)  23 10/108 (9.26%)  10
Ulcers or genital sores  [6]  0/102 (0.00%)  0 1/108 (0.93%)  1
Hepatitis B  [6]  0/102 (0.00%)  0 1/108 (0.93%)  1
Hepatitis C  [6]  0/102 (0.00%)  0 2/108 (1.85%)  2
HIV  [6]  1/102 (0.98%)  1 0/108 (0.00%)  0
Anal precancer  [6]  0/102 (0.00%)  0 1/108 (0.93%)  1
Cancer  [6]  0/102 (0.00%)  0 1/108 (0.93%)  1
Indicates events were collected by systematic assessment
[1]
AE reported in calendar. Non-response for 27 in the carrageenan and 31 in the placebo arm.
[2]
AE reported in survey. Non-response for 3 participants in the carrageenan and 5 in the placebo arm.
[3]
AE reported in survey. Non-response for 7 participants in the carrageenan and 7 in the placebo arm.
*
Indicates events were collected by non-systematic assessment
[4]
Conditions reported by nurse at the clinic visit.
[5]
Infections/conditions reported by participant in survey. Non-response for 7 participants in the carrageenan and 16 in the placebo arm.
[6]
Infections/conditions reported by participant in survey.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Eduardo Franco
Organization: Division of Cancer Epidemiology, Department of Oncology, McGill University
Phone: 514-398-6032
EMail: eduardo.franco@mcgill.ca
Layout table for additonal information
Responsible Party: Dr. Eduardo Franco, McGill University
ClinicalTrials.gov Identifier: NCT02354144    
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 Submitted: January 29, 2015
First Posted: February 3, 2015
Results First Submitted: April 28, 2021
Results First Posted: June 15, 2021
Last Update Posted: June 15, 2021