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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| % 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study. | By monitoring activities related with pharmacovigilance duties during the patient participation of each patient. | 48 weeks |
| Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital U. Vall d'Hebrón | Barcelona | Catalonia | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40036375 | Derived | 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. |
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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.
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| 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) |
|
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| 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) |
|
|
To describe the proportion of clinic and laboratory adverse events, which imply treatment dropout, in research treatment arm especially (cidofovir and sinecatechins). By monitoring activities related with pharmacovigilance duties during the patient participation of each patient |
| 48 weeks |
| Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ). | HIVTSQ has been modified by replacing the references to "HIV treatment" with "anal dysplasia treatment", and eliminating question 2 of HIVTSQ. The following questions are related to the treatment you are being given in the trial and your experience in recent weeks. Please answer each question by circling a number on each of the scales evaluating them from 6 (very satisfied) to 0 (not satisfied).
| 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). | To compare % of decreased extension of HGAIN patients, with absence of regression during the study period according to protocol schedule. | 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). | To compare % of Human Papilloma Virus clearance in patients during the study period according to protocol schedule. | 10 weeks (+/- 4 weeks) after end of treatment |
| Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment | During the study period according to protocol schedule. | 48 weeks |
| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| D000077404 | Cidofovir |
| D009824 | Ointments |
| C527126 | green tea extract polyphenone E |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D003596 | Cytosine |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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