Efficacy and safety of trichloroacetic acid vs. electrocautery for the topical treatment of anal intraepithelial neoplasia in HIV-positive patients (TECAIN) – a randomized controlled trial - TECAI

niversitätsklinikum Essen0 个研究点目标入组 257 人开始时间: 2015年11月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. HIV-seropositive
•2. Patients of legal competence and age>= 18 years,
•3. Sufficient knowledge of the german language, written and spoken,
•4. Patient is willing to show up regularly to therpay and follow-up visits,
•5. Clinical visible AIN-lesions which are histologically confirmed (result should not be altder than 2 weeks aufter extraction and extraction should not be more than 16 weeks before Baseline),
•6. Informed consent.

•1. Currently diagnosed anal cancer or anal cancer in anamnesis ( in the last 5 years),
•2. Acute life-threatening disease,
•3. Participation in a proctologic study in the last 30 days,
•4. Participation in this study prior to this point,
•5. Simultaenous participation in a study which excludes the participation in this study,
•6. Simultaenous topic therapy and systemic intake of drugs, which influence the study results, e.g. immunmodulating substances: interferons, imiquimod or systemic glucosteroids,
•7. Lactation,
•8. Pregnancy
•9. Women of child-bearing age without sufficient contraception
•10. Known intolerance/contraindication against TCA or ECA,
•11. Patients, who require a general anaesthesia for therapy at baseline,
•12. Other serious intraanal and proktologic diseases, which require additional treatments, which influence the study outcome, e.g. active M. Crohn, which is locally and sytemical treated with Immunesuppressiva, or active STI-Proktitis
•13. Patient, who are vaccinated against HPV before studystart.

发起方

niversitätsklinikum Essen