Status:
COMPLETED
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
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Conditions:
High-grade Anal Intraepithelial Neoplasia
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 electrocoagulati...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04055142
Start Date
September 18 2020
End Date
July 2 2024
Last Update
July 10 2024
Active Locations (1)
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1
Hospital U. Vall d'Hebrón
Barcelona, Catalonia, Spain, 08035