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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- % 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).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Electrocoagulation
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.
干预措施: electrocoagulation (Procedure)
Sinecatechins (10%)
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.
干预措施: sinecatechins 10% topical ointment (Drug)
cidofovir (1%)
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.
干预措施: cidofovir 1% topical ointment (Drug)
结局指标
主要结局
% 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).
时间窗: 10 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.
次要结局
- Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study.(48 weeks)
- % 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)
- Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study.(48 weeks)
- Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment(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)