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.