Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

Summary

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

Timeline

Start

2020-09-18

Primary completion

2024-01-11

Completion

2024-07-02

Outcome

Missed primary endpoint

paper No statistically significant difference was observed in efficacy between treatments; PMID 40036375 ↗

paper 61.1% (95% CI: 45.2%-77%) in the sinecatechins group (P = .189). PMID 40036375 ↗

Publications

• Burgos J, Curran A, Garcia J, Campany D, Descalzo V, Suanzes P, Navarro J, Planas B, Sanchiz M, Landolfi S, Dinares C, Hernandez-Losa J, Falco V. Effectiveness of Electrocautery, Topical Cidofovir, and Topical Sinecatechins for the Treatment of Anal High-Grade Squamous Intraepithelial Lesions in Persons With HIV: An Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2025 Sep 16;81(2):333-340. doi: 10.1093/cid/ciaf086.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CIDOFOVIR ANHYDROUS	Small molecule	1 %	Topical
Subject	Sinecatechins	Unknown	10 %	Topical

Indications