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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01946009
First received: March 21, 2013
Last updated: May 29, 2014
Last verified: September 2013
  Purpose

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


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

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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946009

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Investigators
Principal Investigator: Elena Sendagorta, MD Hospital La Paz
  More Information

No publications provided

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT01946009     History of Changes
Other Study ID Numbers: GESIDA-7412
Study First Received: March 21, 2013
Last Updated: May 29, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Cidofovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014