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Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cidofovir 1% | Experimental | Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. | Drug |
|
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Elena Sendagorta, MD | Hospital La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26731755 | Derived | Sendagorta E, Bernardino JI, Alvarez-Gallego M, Feito M, Feltes R, Beato MJ, Perez-Molina JA, Yllescas M, Diaz-Almiron M, Arribas JR, Gonzalez-Garcia J, Herranz P; CIDAN127412 GESIDA Study Group. Topical cidofovir to treat high-grade anal intraepithelial neoplasia in HIV-infected patients: a pilot clinical trial. AIDS. 2016 Jan 2;30(1):75-82. doi: 10.1097/QAD.0000000000000886. |
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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 |
| ID | Term |
|---|---|
| D000077404 | Cidofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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