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A Randomized, Placebo-Controlled Phase II Study of Multiple Dosing Regimens of Intravaginally Administered 851B Gel for the Treatment of Cervical High Risk HPV Infection

Phase 2
18 Years
45 Years
Not Enrolling
Papillomavirus Infections

Thank you

Trial Information

A Randomized, Placebo-Controlled Phase II Study of Multiple Dosing Regimens of Intravaginally Administered 851B Gel for the Treatment of Cervical High Risk HPV Infection

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.

Inclusion Criteria:

- A female subject of childbearing potential who is sexually active using

- 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

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time to clearance of high-risk human papillomavirus infection.

Outcome Time Frame:

At each visit

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

June 2008

Related Keywords:

  • Papillomavirus Infections
  • Cervical Neoplasms
  • Drug Therapy
  • Human Papillomavirus
  • Cervical Human Papillomavirus
  • Cervical Dysplasia
  • Chemoprevention
  • High Risk Cervical Human Papillomavirus
  • Atypical Squamous Cells of Undetermined Significance
  • Low Grade Intraepithelial Lesions
  • Papillomavirus Infections



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