Clinical trial · Interventional
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
A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-grade Anal Intraepithelial Neoplasia | High Grade Anal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cidofovir 1% topical ointment | Drug | — | UNRESOLVED |
| electrocoagulation | Procedure | — | UNRESOLVED |
| sinecatechins 10% topical ointment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Electrocoagulation
- description
- This procedure will be implemented following the Standard of Care (SoC) on weeks: 0, 8 and 16 calculated since the day the patient is included into the trial.
- interventionNames
- Procedure: electrocoagulation
- type
- EXPERIMENTAL
- label
- Sinecatechins (10%)
- description
- Topical ointment wich contains 2 grams of active principle (sinecatechins 10%) at each administration. It will be taken three times per week during 8 weeks of treatment.
- interventionNames
- Drug: sinecatechins 10% topical ointment
- type
- EXPERIMENTAL
- label
- cidofovir (1%)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men who have sex with men, older or same than 18 years old. * HIV-1 positive men. * High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study. * Informed consent is signed voluntarily. Exclusion Criteria: * Patient with any disease or condition which rules him out to participate in the research, by investigator opinion. * Treated patients for HGAIN in the previous 6 months. * Patients with relapsed HGAIN two or more times in the last three months. * People with learning difficulties
References
Publications (1)
- DERIVEDBurgos 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. PMID 40036375