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

Not Applicable

Completed

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

• Registration Number: NCT01946009
• Lead Sponsor: Fundacion SEIMC-GESIDA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-21
• Study Start: 2013-09
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-05
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

2. 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.

3. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cidofovir 1%	Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.	Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain