Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients

NACompletedINTERVENTIONAL
Enrollment

560

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

March 31, 2020

Study Completion Date

December 31, 2021

Conditions
Anal Intraepithelial Neoplasia (AIN) in HIV-infected Patients
Interventions
OTHER

Topical 85% trichloroacetic acid (TCA)

In the experimental intervention arm, all visible lesions are treated with 85% TCA by dipping the wooden stick end of a cotton swab into a cup containing TCA. The stick end is saturated with TCA and is inserted through the anoscope and directed to the lesion under HRA guidance. TCA is applied to the lesion repeatedly until the lesion changes to a dense white colour. Each TCA application session is followed by another appointment four weeks later, where the clinician re-evaluates the lesions of the patient and determines whether a next TCA application is necessary up to a maximum of four times

PROCEDURE

Surgical electrocautery (ECA)

In the control arm, HRA-guided ECA, is performed every 4 weeks up to a maximum of four times. All visible lesions are ablated at every visit. Bleeding from small vessels can be stopped by ECA. Patients undergo local anaesthesia if necessary

Trial Locations (1)

45147

Universitätsklinikum Essen, Klinik für Dermatologie, Essen

All Listed Sponsors
lead

University Hospital, Essen

OTHER

NCT02615860 - Efficacy and Safety of TCA vs. ECA for the Treatment of AIN in HIV-positive Patients | Biotech Hunter | Biotech Hunter