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 (CIDAN12)

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Universitario La Paz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cidofovir 1%; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion SEIMC-GESIDA
• Investigators: Principal Investigator: Elena Sendagorta, MD, Hospital La Paz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: March 21, 2013
• First Submitted That Met QC Criteria: September 16, 2013
• First Posted (Estimate): September 19, 2013

Study Record Updates

• Last Update Posted (Estimate): June 29, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Cidofovir
• Other Study ID Numbers: GESIDA-7412