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

HIV Clinical Trial

— CIDAN12  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946009
• Other study ID #: GESIDA-7412
• 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

• Carcinoma in Situ
• HIV

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