Clinical TrialID 6627
Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients
NCT02615860
Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6627
- Evidence Id
- 6627
- Core Evidence Id
- 6627
- Source Clinical Trial Id
- 6614
- Herb2 Clinical Trial Id
- HBCT006614
- Nct Id
- NCT02615860
- Title
- Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- OTHER: Topical 85% trichloroacetic acid (TCA)|PROCEDURE: Surgical electrocautery (ECA)
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 560
- Outcome Measure
- Therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN2/3 to AIN1) of AIN, The primary endpoint is therapeutic success (success rate) defined as clinically (HRA) and histologically confirmed resolution (normal histology) or regression (from AIN 2/3 to AIN1) of AIN four weeks after the last treatment within TECAIN. Patients not showing up at this mandatory follow-up appointment will be counted as treatment failure. Histologically confirmed resolution/regression 4 (to 8) weeks after therapy has been the primary endpoint in the two published RCTs and in several pilot studies. Clearance of AIN after treatment is the most relevant endpoint for patients, since AIN can rapidly progress to AC in HIV+ patients., Four weeks after the last treatment within TECAIN
- Sponsor Collaborator
- University Hospital, Essen
- Funded By
- OTHER
- Location
- Universitätsklinikum Essen, Klinik für Dermatologie, Essen, Nordrheinwestfalen, 45147, Germany
- Other Id
- 01KG1425
- Start Date
- 2015-11
- Primary Completion Date
- 2020-03-31
- Completion Date
- 2021-12-31
- First Posted
- 2015-11-26
- Results First Posted
- Last Update Posted
- 2022-11-08
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT02615860
- Title Cn
- Title En
- Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients
- Bilingual Status
- semi_complete