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

Inclusion Criteria: * A female subject of childbearing potential who is sexually active using contraception. * Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration. * Subject must be neither pregnant nor lactating from Screening throughout the duration of the study. * Subject has 1 of the following: * Menstruating with a stable cycle and has at least 21 non-bleeding days. * Amenorrheic (due to injectable or extended-cycle contraceptives). * Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit. * Subject has a Pap test interpretation of either low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance. * Subject has a uterine cervical sample that is high-risk human papillomavirus positive. Exclusion Criteria: * The Subject has evidence of an uncontrolled, clinically significant medical condition as determined by the investigator. * The Subject has a history of hemorrhagic diatheses or coagulopathy. * The Subject has a history of toxic shock syndrome. * The Subject has received any of the following medications in the timeframes listed below: * 851 (in any form) or an active (non-placebo) human papillomavirus vaccine at any time prior to the screening visit. * In the 4 weeks prior to the screening visit the subject has received: * Interferon therapy or other therapies that promote a proinflammatory immune state, including: * immunomodulators. * cytotoxic drugs. * drugs known to have major organ toxicity. * Used a vaginal douche 72 hours prior to the screening visit. * Received any investigational drug within 60 days of Study Day 1. * Used in the 2 weeks prior to Study Day 1: * oral or inhaled corticosteroids (\>1000 mcg/day, fluticasone propionate \>600 mg/day, or equivalent). * systemic steroids. * topical drugs to the anogenital area. * NuvaRing. * The Subject has a history of hypersensitivity to any components of the gel formulation or to iodine. * The Subject has given birth or has had a spontaneous or induced abortion within 2 months of Study Day 1. * The Subject uses an intrauterine device, diaphragm, NuvaRing, or additional contraceptive foam or gel for birth control. * The Subject has: * histology read as high-grade cervical intraepithelial neoplasia. * cytology read as high-grade squamous intraepithelial lesion. * cytology read as atypical glandular cytological abnormalities. * cytology read as atypical squamous cells - cannot exclude high grade. * cervical carcinoma of any type. * apparent endocervical involvement. * high-grade vulvar intraepithelial neoplasia. * high-grade vaginal intraepithelial neoplasia. * If the limits of a cervical lesion cannot be readily visualized. * If the limits of the transformation zone cannot be readily visualized. * The subject has clinical evidence of a vaginal infection or sexually transmitted infection, other than cervical human papillomavirus infection at the Study Day 1 visit. * The Subject has had a cervical biopsy within 1 month prior to the screening visit. * The Subject has had any previous ablative or surgical treatment of the cervix within 3 months prior to the screening visit; * The Subject has a history of alcoholism or substance abuse within 1 year or has current alcohol or substance abuse as assessed by the investigator. * The Subject has tested positive for human immunodeficiency virus at the screening visit or has evidence of any other immunosuppressive disease.