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 (TreatAIN)

Vall d'Hebron University Hospital (HUVH)

Status and phase: Completed; Phase 3

Conditions: High-grade Anal Intraepithelial Neoplasia

Treatments: Drug: cidofovir 1% topical ointment; Drug: sinecatechins 10% topical ointment; Procedure: electrocoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04055142

TreatAIN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Electrocoagulation

Active Comparator group

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.

Treatment:

Procedure: electrocoagulation

Sinecatechins (10%)

Experimental group

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.

Treatment:

Drug: sinecatechins 10% topical ointment

cidofovir (1%)

Experimental group

Description:

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.

Treatment:

Drug: cidofovir 1% topical ointment