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 个研究点目标入组 20 人开始时间: 2012年4月26日最近更新: 2015年1月19日

适应症

试验速览

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•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

•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.

发起方

Fundación SEIMC-GESIDA