Intraephitelial Anal Neoplasia
Conditions
Interventions
Trade Name: Vistide
Product Name: Cidofovir
Pharmaceutical Form: Cream
INN or Proposed INN: CIDOFOVIR
CAS Number: 113852-37-2
Concentration unit: g gram(s)
Concentration type: range
Concentration numb
Sponsors
Fundación SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion 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 ISAs 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1. Patients who have received previous treatment of IAN in the last 12 weeks. 2. Dermatoses in patients with anogenital area 3. Patients with a history of pre-invasive neoplasia associated with HPV 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN)-guided biopsy confirmed high-resolution anoscopy.;Secondary Objective: Describe the percentage of patients in reducing the degree of dysplasia of the NIA Describe the percentage of patients in reducing the extent of ISA quadrants, although not complete regression. Describe the percentage of patients who relapse occurs, and the mean time they occur. Describe the percentage of patients who clears HPV after treatment with cidofovir Describe the safety and tolerability of cidofovir topical application intraanal. Prospective clinical trial of exploratory character, to estimate the effect of treatment.;Primary end point(s): Clinical and histological regression of the IAN at 8 weeks of stopping treatment with cidofovir 1% for 4 weeks.;Timepoint(s) of evaluation of this end point: 8 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The percentage of patients in reducing the number of quadrants affections by scanning with the anoscope 2. Variations in histological grading of the ISA (stabilization, worsening or improvement) estimated percentage 3. The percentage of patients in whom recurrence occurs in the follow-up period of 6 and 12 months The percentage of patients in whom there is a clearance of oncogenic HPV. 4. The percentage of patients with mild topical side effects, moderate or severe. The percentage of patients with systemic side effects if any.;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Spain
Contacts
Public ContactMiriam Ramírez
Fundación SEIMC-GESIDA
Outcome results
None listed