Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
First posted: 2013-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percentage of patients with complete regression of anal intraepithelial neoplasia
timeFrame: 8 Weeks
Secondary outcomes:
measure: Describe the percentage of patients that reduce the degree of Anal dysplasia
timeFrame: 8 weeks
measure: Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression
timeFrame: 8 Weeks
measure: Time to relapse
timeFrame: 8 Weeks
measure: Percentage of patients with clear of Human papillomavirus
timeFrame: 8 Weeks
measure: Percentage of adverse events
timeFrame: 8 weeks
measure: Treatment effect
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital La Paz
name: Elena Sendagorta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.