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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117884

Enrollment

240

Registered

2005-07-11

Start date

2006-04-30

Completion date

2008-06-30

Last updated

2016-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillomavirus Infections

Keywords

Papillomavirus infections;, Cervix Dysplasia

Brief summary

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.

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.

Interventions

DRUG851B

851B 0.15% formulation, gel, topically, twice a week for 2 cycles.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
Time to progression of disease to precancer.	Visits 1-3 as assigned by group
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
Change in relative light units ratios relative to the positive control from Hybrid Capture 2® assay (semi-quantitatively assessing viral load).	At each visit

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026