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

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.