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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01946009
Other study ID # GESIDA-7412
Secondary ID
Status Completed
Phase N/A
First received March 21, 2013
Last updated June 28, 2016
Start date September 2013
Est. completion date September 2014

Study information

Verified date May 2015
Source Fundacion SEIMC-GESIDA
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - Inclusion Criteria:

1. Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.

2. 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.

3. 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Spain Hospital Universitario La Paz Madrid

Sponsors (1)

Lead Sponsor Collaborator
Fundacion SEIMC-GESIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary Time to relapse Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse 8 Weeks No
Secondary Percentage of patients with clear of Human papillomavirus Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir 8 Weeks No
Secondary Percentage of adverse events Describe the number of patients with adverse events as a measure of safety and tolerability 8 weeks No
Secondary Treatment effect Prospective Clinical Trial exploratory nature of the effect of treatment. 8 Weeks No
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