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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Unnamed facility
Colton, California, United States
Unnamed facility
San Diego, California, United States
Time to clearance of high-risk human papillomavirus infection.
Time frame: At each visit
Proportion of subjects with evidence of regression to normal cytology.
Time frame: 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).
Time frame: At each visit
Proportion of subjects who develop histological evidence of cervical intraepithelial neoplasia.
Time frame: Visits 1-3 as assigned by group
Time to progression of disease to precancer.
Time frame: 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).
Time frame: At each visit
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851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
851B 0.15% formulation, gel, topically, twice a week for 2 cycles.
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Augusta, Georgia, United States
Unnamed facility
Savannah, Georgia, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Moorestown, New Jersey, United States
...and 13 more locations