High-grade anal intraepithelial neoplasia
Conditions
Interventions
Trade Name: Veregen
Product Name: Veregen
Pharmaceutical Form: Ointment
INN or Proposed INN: Camellia sinensis
Kuntze folium
epigalocatequina galato
Other descriptive name: CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT
Concentration unit: % percent
Concentration type: equal
Sponsors
Fundación Hospital Vall d'Hebron- Institut de Recerca
Eligibility
Sex/Gender
Male
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prove the efficacy and safety non-inferiority of cidofovir 1% ointment or sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia with respect to electrocoagulation treatment in HIV-positive men and men who have sex with men.; Secondary Objective: -To compare patients proportion with any adverse event during the treatment. -To describe the proportion of clinic and laboratory adverse events, which imply treatment dropout, in research treatment arm especially (cidofovir and sinecatechins). -To evaluate the patient satisfaction about the different treatments by pre-established surveys. -To compare the proportion of decreased extension of HGAIN patients, with absence of regression, 10 weeks (+/- 4 weeks) after end of treatment. -To compare proportion of Human Papilloma Virus clearance in patients 10 weeks (+/- 4 weeks) after end of treatment. -To evaluate 10 weeks (+/- 4 weeks) after end of treatment the expression variability of cellular proliferation markers and dysplasia, and their association with treatment result and recurrence. -To describe the patients proportion with HGAIN recurrence after a complete or partial result, and medium until recurrence. -To analize the costs of the three treatment arms. ;Primary end point(s): The patients proportion with complete or partial regression of HGAIN at 10 weeks (+/-4 weeks) after the end of treatment.;Timepoint(s) of evaluation of this end point: At 10 week (+/-4 weeks) after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Related to HIV infection: CD4+ cell count, HIV viral load, antiretroviral treatment. -Related to sexual habits: number of sexual partners, condom use, sexually transmitted infections. -Related to anal dysplasia: Previous anal dysplasia history, recieved treatments, size and location of actual anal dysplasia, actual anal cellular proliferation markers and after treatment. -Related to HPV infection: Previous HPV infection, actual and after treatment. -Related to laboratory alterations: hemogram, renal function, liver function. -Related to safety: Adverse events during the research. -Related to compliance: Pre-established survey and collection of leftover medication. ;Timepoint(s) of evaluation of this end point: During all the reasearch | — |
Countries
Spain
Contacts
Public ContactJoaquin Burgos
Fundació Hospital Vall d'Hebron- Institut de Recerca
Outcome results
None listed