NCT02382419

Carrageenan-Containing Gel in Reducing the Rate of HPV Infection in Healthy Participants

Expanded Phase II Trial of a Carrageenan-Containing Gel for Prevention of HPV Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 19 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This randomized phase II trial studies how well carrageenan-containing gel (vaginal gel) works in reducing the rate of human papilloma virus (HPV) infection in healthy participants. Carrageenans, which are naturally derived from seaweed, are enhancements to natural lubrication and may be effective in blocking HPV infection.

Detailed description

PRIMARY OBJECTIVES: I. To measure the overall efficacy of the intervention in reducing the rate of incident cervical HPV infection. SECONDARY OBJECTIVES: I. Perform in vitro exploratory testing of how long after vaginal application the drug retains biological activity by collecting cervicovaginal lavage (CVL) at different times and spiking the samples with HPV pseudovirions (PsVs) and measuring PsV entry into target cells. II. These studies will be expanded to test multiple HPV types and to examine whether the anti-HPV activity of the intervention is preserved in the setting of semen. III. Store swabs to potentially test candidate biomarkers of microbicide efficacy and safety. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants apply carrageenan-containing gel vaginally within 12 hours prior to each vaginal sex act and as soon as possible within 12 hours after each vaginal sex act and use condoms for 12 months. ARM II: Participants apply placebo gel vaginally within 12 hours prior to each vaginal sex act and as soon as possible within 12 hours after each vaginal sex act and use condoms for 12 months.

Conditions

• Healthy Subject
• Human Papillomavirus Infection

Interventions

Type	Name	Description
DRUG	carrageenan-containing gel	Applied vaginally
OTHER	Placebo	Applied vaginally
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2016-02-24
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2015-03-06
• Last updated: 2019-08-01

Locations

1 site across 1 country: United States