Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients (NCT02615860) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients
Germany560 participantsStarted 2015-11
Plain-language summary
Comparative evaluation of efficacy and safety of high-resolution anoscopy (HRA)-guided topical treatment (trichloroacetic acid, TCA) vs. surgical treatment (electrocautery, ECA) in HIV-positive patients for human papillomavirus (HPV)- induced AIN, an anal cancer precursor. The primary hypothesis is that cost-saving and simple TCA treatment is non-inferior to the current best option therapy with ECA. TCA treatment would also be possible in the normal setting of a doctor´s office without extensive specialization and without complex technical equipment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* HIV positive patients
* Legally eligible patients and age ≥ 18 years
* Sufficient knowledge of the German language, spoken and written
* Patient is willing and able to appear regularly to the treatment- and follow-up appointments
* Clinically visible AIN-lesion, which was confirmed by histopathology (findings not older than 2 weeks after the date of collection and removal date no longer than 16 weeks prior to baseline)
* Written informed consent
Exclusion Criteria:
* Currently diagnosed anal cancer or anal cancer in anamnesis (within the last 5 years)
* Acute life-threatening disease
* Participation in a proctologic study within the last 30 days
* Participation in this study at an earlier date
* Simultaneous participation in another clinical trial, which excludes the participation in this study
* Simultaneous topical and systemic treatments wtih medications that affect the study outcome, such as immunomodulatory substances: Interferone, imiquimod or systemic glucocorticosteroids
* lactation
* Pregnancy: In patients of childbearing age, a pregnancy has to be ruled out by pregnancy test or other suitable methods.
* Women of childbearing potential without adequate contraceptive protection.
* Contraindication for using trichloroacetic acid or electrocautery
* Patients in whom general anesthesia in the treatment of AIN is necessary already at study start
* Other serious intra-anal and proctologic disorders, which make additional proctologic or systemic tre…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN
Timeframe: Four weeks after the last treatment within TECAIN