A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients

Study Overview
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Brief Summary
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Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).

Official Title
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A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients

Conditions
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HIV

Intervention / Treatment
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* Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given informed consent in writing of the study before making any specific selection procedure for the study. Adult patients (18 years) with documented HIV infection, with high-grade AIN demonstrated by biopsy, and have not received any prior treatment for Anal Intraepithelial Neoplasia in the last 12 weeks. For women of childbearing potential, negative pregnancy test in urine screening visit. All women of childbearing age should continue effective contraception throughout the study treatment. Exclusion Criteria: 1. Patients who have received previous treatment of Anal Intraepithelial Neoplasia (AIN) in the last 12 weeks. 2. Dermatoses in patients with anogenital area 3. Patients with a history of pre-invasive neoplasia associated with Human Papilloma Virus 4. Patients with a history of previous neoplasm, of any origin and location, in the past 5 years. 5. Patients with a history of hematologic abnormalities, kidney or liver 6. Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator. 7. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 1%<br>Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. | Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete regression of anal intraepithelial neoplasia | Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN), as confirmed by means of high-resolution anoscopy and biopsy | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the percentage of patients that reduce the degree of Anal dysplasia | Describe the percentage of patients that reduce the degree of Anal dysplasia | 8 weeks | 
| Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression | Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression | 8 Weeks | 
| Time to relapse | Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse | 8 Weeks | 
| Percentage of patients with clear of Human papillomavirus | Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir | 8 Weeks | 
| Percentage of adverse events | Describe the number of patients with adverse events as a measure of safety and tolerability | 8 weeks | 
| Treatment effect | Prospective Clinical Trial exploratory nature of the effect of treatment. | 8 Weeks |