Clinical trial NCT04055142: 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: High-grade Anal Intraepithelial Neoplasia
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: % 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).
timeFrame: 10 weeks
Secondary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study.
timeFrame: 48 weeks
measure: Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study.
timeFrame: 48 weeks
measure: Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
timeFrame: 48 weeks
measure: % 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).
timeFrame: 10 weeks (+/- 4 weeks) after end of treatment
measure: % of patients with no Human Papilloma Virus(HPV) detection at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
timeFrame: 10 weeks (+/- 4 weeks) after end of treatment
measure: Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital U. Vall d'Hebrón
state: Catalunya
Study officials:
References: