NCT04055142CompletedPhase 3
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
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 19 Jul 2019
- Start date
- 18 Sept 2020
- Primary completion date
- 11 Jan 2024
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Diseases
- HIV
- NCT number
- NCT04055142
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 108
- From 18 Sept 2020 to the primary completion date, 11 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treated patients for HGAIN in the previous 6 months.
Other illness
- Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.
Other
- Patients with relapsed HGAIN two or more times in the last three months.
- People with learning difficulties
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital U. Vall d'Hebrón Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.