Clinical Trials

MainTitle

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)

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified August 2019 by Hospital Universitari Vall d'Hebron Research Institute

Sponsor
Hospital Universitari Vall d'Hebron Research Institute


Information provided by (Responsible Party)
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier
NCT04055142

First received: July 19, 2019
Last updated: August 19, 2019
Last Verified: August 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
High-grade Anal Intraepithelial Neoplasia

Procedure : electrocoagulation
Drug : cidofovir 1% topical ointment
Drug : sinecatechins 10% topical ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

Primary Outcome Measures

  • % 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). [ Time Frame: 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.
Secondary Outcome Measures:
  • Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study. [ Time Frame: 48 weeks ]
    By monitoring activities related with pharmacovigilance duties during the patient participation of each patient.
  • Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study. [ Time Frame: 48 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
  • Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ). [ Time Frame: 48 weeks ]
    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). To what extent are you satisfied with your current treatment? To what extent are you satisfied with the side effects you have had from your current treatment? To what extent are you satisfied with the requirements related to your current treatment? To what extent do you consider your treatment to be comfortable / practical? o what extent do you think your treatment is flexible? To what extent are you satisfied with the information / knowledge you have about anal dysplasia? To what extent are you satisfied with the degree to which the treatment adapts to your
  • % 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). [ Time Frame: 10 weeks (+/- 4 weeks) after end of treatment ]
    To compare % of decreased extension of HGAIN patients, with absence of regression during the study period according to protocol schedule.
  • % of patients with no Human Papilloma Virus(HPV) detection at 10 weeks after end of treatment (with a permitted deviation of 4 weeks). [ Time Frame: 10 weeks (+/- 4 weeks) after end of treatment ]
    To compare % of Human Papilloma Virus clearance in patients during the study period according to protocol schedule.
  • Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment [ Time Frame: 48 weeks ]
    During the study period according to protocol schedule.

Estimated Enrollment: 105
Study Start Date: September 2019
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: 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.
Procedure: electrocoagulation

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)

Experimental: 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.
Drug: sinecatechins 10% topical ointment

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)

Other Name: Veregen ointment
Experimental: 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.
Drug: cidofovir 1% topical ointment

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)

Other Name: Cidofovir

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

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04055142

Contacts

Contact:   Joaquin Burgos Cibrian, Dr. 934894497 jburgos@vhebron.net

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute
More Information

More Information


Responsible Party: Hospital Universitari Vall d'Hebron Research Institute  
ClinicalTrials.gov Identifier: NCT04055142   History of Changes  
Other Study ID Numbers: TreatAIN  
Study First Received: July 19, 2019  
Last Updated: August 19, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Carcinoma in Situ
Neoplasms
Cidofovir

ClinicalTrials.gov processed this data on April 08, 2020
This information is provided by ClinicalTrials.gov.