EUCTR2012-001612-34-ESActive, not recruitingNot Applicable
A prostective, 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 Intraephitelial Neoplasia, high level, in HIV+ patients
Fundación SEIMC-GESIDA0 sites20 target enrollmentStarted: April 26, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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