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

Last updated: July 9, 2024
Sponsor: Hospital Universitari Vall d'Hebron Research Institute
Overall Status: Completed

Phase

3

Condition

Genitourinary Cancer

Neoplasms

Precancerous Condition

Treatment

electrocoagulation

cidofovir 1% topical ointment

sinecatechins 10% topical ointment

Clinical Study ID

NCT04055142
TreatAIN
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 monthsprevious to study.

  • Informed consent is signed voluntarily.

Exclusion

Exclusion Criteria:

  • Patient with any disease or condition which rules him out to participate in theresearch, 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

Study Design

Total Participants: 108
Treatment Group(s): 3
Primary Treatment: electrocoagulation
Phase: 3
Study Start date:
September 18, 2020
Estimated Completion Date:
July 02, 2024

Study Description

This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost).

Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation.

On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.

Connect with a study center

  • Hospital U. Vall d'Hebrón

    Barcelona, Catalunya 08035
    Spain

    Site Not Available

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