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)

This study is not yet open for participant recruitment.
Verified September 2013 by Fundacion SEIMC-GESIDA
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01946009
First received: March 21, 2013
Last updated: September 16, 2013
Last verified: September 2013

March 21, 2013
September 16, 2013
September 2013
September 2014   (final data collection date for primary outcome measure)
Percentage of patients with complete regression of anal intraepithelial neoplasia [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN), as confirmed by means of high-resolution anoscopy and biopsy
Same as current
Complete list of historical versions of study NCT01946009 on ClinicalTrials.gov Archive Site
  • Describe the percentage of patients that reduce the degree of Anal dysplasia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression
  • Time to relapse [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse
  • Percentage of patients with clear of Human papillomavirus [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir
  • Percentage of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Describe the number of patients with adverse events as a measure of safety and tolerability
  • Treatment effect [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    Prospective Clinical Trial exploratory nature of the effect of treatment.
Same as current
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
Experimental: Cidofovir 1%
Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
Intervention: Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
March 2015
September 2014   (final data collection date for primary outcome measure)
  • 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.

Both
18 Years and older
No
Not Provided
Spain
 
NCT01946009
GESIDA-7412
No
Fundacion SEIMC-GESIDA
Fundacion SEIMC-GESIDA
Not Provided
Principal Investigator: Elena Sendagorta, MD Hospital La Paz
Fundacion SEIMC-GESIDA
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP