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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Papillomavirus Infections

Intervention / Treatment
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* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B
* Drug: 851B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 2<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 3<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 4<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 5<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 6<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 7<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 8<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 9<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 10<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|
| Experimental: 11<br> | Drug: 851B<br>* 851B 0.15% formulation, gel, topically, twice a week for 2 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to clearance of high-risk human papillomavirus infection. |  | At each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to progression of disease to precancer. |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Papillomavirus infections;, Cervix Dysplasia