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OpenTrials
Completed

NCT Number: NCT01946009

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).

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Key information

Conditions

HIV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
  • 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.
  • 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:
  • 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.
  • 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.
  • Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.

Treatment and study plan

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

Drug

Primary outcomes

  1. Percentage of patients with complete regression of anal intraepithelial neoplasia

    Time frame: 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 outcomes

  1. Describe the percentage of patients that reduce the degree of Anal dysplasia

    Time frame: 8 weeks

    Describe the percentage of patients that reduce the degree of Anal dysplasia

  2. Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression

    Time frame: 8 Weeks

    Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression

  3. Time to relapse

    Time frame: 8 Weeks

    Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse

  4. Percentage of patients with clear of Human papillomavirus

    Time frame: 8 Weeks

    Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir

  5. Percentage of adverse events

    Time frame: 8 weeks

    Describe the number of patients with adverse events as a measure of safety and tolerability

  6. Treatment effect

    Time frame: 8 Weeks

    Prospective Clinical Trial exploratory nature of the effect of treatment.

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Registry information

Acronym: CIDAN12

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 19, 2013
Registry last updated
Jun 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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