A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.

Study Overview
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Brief Summary
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The infections of high grade induced by the human papilloma viruses cause precancerous lesions of the cervical epithelium. The progression of these lesions can lead to the onset of cervical cancer. To reduce the risk of cancer lesions classified as 'cervical squamous intraepithelial neoplasia 2' (CIN2) and 'cervical squamous intraepithelial neoplasia 3' (CIN3), the standard treatment is the conisation of the cervix. This surgery can lead to complications such as infertility or a risk of preterm birth, hence the need to move towards a non-surgical alternative therapy. The colvir clinical trial was a phase-II, multi center, randomized, double blind, efficacy study of an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3). This clinical trial is a prolongation of the colvir trial, in order to assess the long term histological and virological evolution (24 months) of 3 g of 2% (w/w) cidofovir gel, administrated directly on cervix exhibiting high grade intraepithelial neoplasia after complete response, partial response or response failure at the end of the Colvir study. assess the long term (24 months) rate of recurrence of histological lesions of the Colvir patients after conisation, in both placebo and treatment groups.

Official Title
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A Prolongation of Phase II Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions

Conditions
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High Grade Cervical Epithelial Neoplasia (CIN2+)

Intervention / Treatment
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* Drug: Cidofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women who participated in the COLVIR study and received complete treatment Exclusion Criteria: Women from the Colvir study who received incomplete treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cidofovir<br>Women receiving an aqueous gel containing 2% (w/w) cidofovir, administrated directly on cervix exhibiting high grade squamous intraepithelial lesion (CIN 2 and 3). | Drug: Cidofovir<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in biopsy conclusions (treatment success or not) | A gynecological examination will be done, including colposcopy. Cervical sampling for virology will be taken and sent to Riatol laboratory. A biopsy will be taken in presence of colposcopic cervical squamous intraepithelial neoplasia (CIN2-3) lesions, or in case of colposcopic doubt lesions, or in case of persistence (after 6 months) of colposcopic CIN1 lesion or if the last cytology was a high grade squamous intraepithelial lesion (HSIL) cytology, or if the last cytology suspected glandular lesions, or if the two last cervical smears were low-grade intraepithelial lesion (LSIL) cytologies with presence of high risk human papillomavirus (HPV).The biopsy fixation, HE (eosin-hematoxylin) staining and P16 + Ki67 staining will be done according to a validated procedure. Biopsy slides will be send to the central lab for immunological and histological reading (three pathologic experts). | 24 months after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV viral load | Cervical sampling for virology will be taken and send to Riatol laboratory. | 24 months after initial treatment | 
| HPV genotype | Cervical sampling for virology will be taken and send to Riatol laboratory. | 24 months after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colvir, high grade squamous intraepithelial lesions, cervix