Efficacy of 851B Gel for Treating High-Risk Cervical Human Papillomavirus Infection in Women.

A Randomized, Double-blind, Placebo-Controlled, Dose Response Study to Evaluate 851B Gel Delivered Intravaginally Twice a Week for Two, Three-Week Cycles in Women Who Are Positive For High-Risk Genotypes of Human Papillomavirus and Have Mild Cytological Abnormalities

The purpose of this study was to evaluate efficacy of 851B gel over a range of concentrations and dosing regimens on high-risk cervical human papillomavirus infection in women.

Study Overview

• Status: Terminated
• Conditions: Papillomavirus Infections
• Intervention / Treatment: Drug: 851B

Detailed Description

Cervical cancer is caused by infection with specific genotypes of the human papillomavirus referred to as oncogenic or high-risk human papillomavirus. Current epidemiologic evidence suggests that 80% of sexually active women will become infected during their lifetime with human papillomavirus and 50% of these infections will be due to high-risk human papillomavirus. With US annual rates of cervical cancer now in the range of 13,000/year, a very substantial number of women are left with uncertainty regarding whether their infection will clear spontaneously or progress to cancer.

Subjects participating in this study were required to visit the clinic for approximately 15 or 16 visits, and maintain a diary of self-dosing and menstruation cycles. The total time of participation in this study was approximately 27 months.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1S 2L6
• United States
  • California
    • Colton, California, United States, 92324
    • San Diego, California, United States, 92108
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
  • Florida
    • Boynton Beach, Florida, United States, 33461
    • Tampa, Florida, United States, 33607
  • Georgia
    • Augusta, Georgia, United States, 30912
    • Savannah, Georgia, United States, 31405
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • Michigan
    • Detroit, Michigan, United States, 48201
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
  • New York
    • New York, New York, United States, 10032
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
    • Winston-Salem, North Carolina, United States, 27103
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
  • Tennessee
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Arlington, Texas, United States, 76012
    • Austin, Texas, United States, 78705
    • Houston, Texas, United States, 77004
  • Washington
    • Renton, Washington, United States, 98055
    • Seattle, Washington, United States, 98105
    • Spokane, Washington, United States, 99207

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Willing to be on acceptable method of birth control
• Have a Pap smear result of LSIL or ASCUS
• Is high risk HPV positive

Exclusion Criteria:

• No evidence of high-grade disease or glandular abnormalities,
• Complete visualization of all lesion margins and the transformation zone,
• No uncontrolled significant medical illness or sexually transmitted infections,
• Taking any restricted medications such as interferon, immunomodulators, cytotoxic drugs, investigational drugs, steroids.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 2	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 3	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 4	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 5	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 6	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 7	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 8	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 10	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 11	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Experimental: 9	Drug: 851B; 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to clearance of high-risk human papillomavirus infection.	At each visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with evidence of regression to normal cytology.	Screening Visit and Follow-up Visits (Months 6, 8, 14, 20, and 26).
Proportion of subjects with improvement in cervical lesions as rated by the investigator (measured by colposcopy).	At each visit
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.	Visits 1-3 as assigned by group
Time to progression of disease to precancer.	Visits 1-3 as assigned by group
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).	At each visit

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: July 1, 2005
• First Submitted That Met QC Criteria: July 8, 2005
• First Posted (Estimate): July 11, 2005

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 16, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Cervix Dysplasia; Papillomavirus infections
• Additional Relevant MeSH Terms: Virus Diseases; DNA Virus Infections; Tumor Virus Infections; Infections; Papillomavirus Infections
• Other Study ID Numbers: 1537-851B; U1111-1127-5850 (Registry Identifier: WHO)