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

NCT04055142 | Completed Phase 3

• 1 other identifier: TreatAIN
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High-grade Anal Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• % of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).

  % of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks). sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia (HGAIN) with respect to electrocoagulation treatment in HIV-positive men who have sex with men.

  10 weeks

Secondary Outcomes (6)

• Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study.

  48 weeks

• Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study.

  48 weeks

• Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ).

  48 weeks

• % of patients who reduce the measurement in HGAIN octants, although without regression, by high-resolution anoscopy at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).

  10 weeks (+/- 4 weeks) after end of treatment

• % of patients with no Human Papilloma Virus(HPV) detection at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).

  10 weeks (+/- 4 weeks) after end of treatment

Study Arms (3)

Electrocoagulation

ACTIVE COMPARATOR

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.

Procedure: electrocoagulation

Sinecatechins (10%)

EXPERIMENTAL

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.

Drug: sinecatechins 10% topical ointment

cidofovir (1%)

EXPERIMENTAL

Topical ointment wich contains 2 grams of active principle (cidofovir 1%) at each administration. It will be taken three times per week during 8 weeks of treatment.

Drug: cidofovir 1% topical ointment

Interventions

electrocoagulation PROCEDURE

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)

Electrocoagulation

cidofovir 1% topical ointment DRUG

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)

Also known as: Cidofovir

cidofovir (1%)

sinecatechins 10% topical ointment DRUG

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)

Also known as: Veregen ointment

Sinecatechins (10%)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital U. Vall d'Hebrón

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (1)

• 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.

  PMID: 40036375 DERIVED

MeSH Terms

Interventions

Electrocoagulation; Cidofovir; Ointments; green tea extract polyphenone E

Intervention Hierarchy (Ancestors)

Cautery; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: August 13, 2019
• Study Start: September 18, 2020
• Primary Completion: January 11, 2024
• Study Completion: July 2, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

ES (1)