Ignite Creation Date:
2024-05-06 @ 7:52 AM
Last Modification Date:
2024-10-26 @ 11:53 AM
Study NCT ID:
NCT02615860
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2015-11-19
Brief Title:
Efficacy and Safety of TCA vs ECA for the Treatment of AIN in HIV-positive Patients
Sponsor:
University Hospital Essen
Organization:
University Hospital Essen
Study Overview
Official Title:
Efficacy and Safety of Topical Trichloroacetic Acid vs Electrocautery for the Treatment of Anal Intraepithelial Neoplasia in HIV-positive Patients TECAIN - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TECAIN
Brief Summary:
Comparative evaluation of efficacy and safety of high-resolution anoscopy HRA-guided topical treatment trichloroacetic acid TCA vs surgical treatment electrocautery ECA in HIV-positive patients for human papillomavirus HPV- induced AIN an anal cancer precursor The primary hypothesis is that cost-saving and simple TCA treatment is non-inferior to the current best option therapy with ECA TCA treatment would also be possible in the normal setting of a doctors office without extensive specialization and without complex technical equipment
Detailed Description:
Anal human papillomavirus HPV-infection and HPV-induced AIN an anal cancer precursor are very frequent in HIV-positive patients HIV especially in men who have sex with men MSM but also in women Consequently HIV have a strongly increased risk for anal cancer Screening for and treatment of AIN are recommended in HIV although only two RCT on AIN treatment have been published We plan a multicenter unblinded non-inferiority RCT that evaluates the efficacy and safety of 2 high-resolution anoscopy HRA-guided treatment options for AIN topical application of trichloroacetic acid TCA and surgical treatment with electrocautery ECA
ECA was the best option for intra-anal AIN in a recent randomized controlled trial RCT TCA an inexpensive and established therapy for genital warts has been evaluated for AIN only in a retrospective pilot study that showed clearance rates comparable to those found for ECA with possibly less adverse events AE Our primary hypothesis is that cost-saving and simple TCA is non-inferior to ECA 2800 HIV will be screened by HRA in 9 proctological centers and 560 HIV with histologically confirmed intra-anal AIN will be randomized 11 to receive up to 4 treatments with TCA or ECA within 12 weeks The primary efficacy endpoint is clinical HRA and histological resolution of AIN 4 weeks after the last treatment Secondary endpoints comprise recurrence of AIN 24 weeks after end of therapy the number of interventions AE and the influence of HPV parameters such as anal HPV-types viral load and HPV-oncogene-mRNA
ECA was the best option for intra-anal AIN in a recent randomized controlled trial RCT TCA an inexpensive and established therapy for genital warts has been evaluated for AIN only in a retrospective pilot study that showed clearance rates comparable to those found for ECA with possibly less adverse events AE Our primary hypothesis is that cost-saving and simple TCA is non-inferior to ECA 2800 HIV will be screened by HRA in 9 proctological centers and 560 HIV with histologically confirmed intra-anal AIN will be randomized 11 to receive up to 4 treatments with TCA or ECA within 12 weeks The primary efficacy endpoint is clinical HRA and histological resolution of AIN 4 weeks after the last treatment Secondary endpoints comprise recurrence of AIN 24 weeks after end of therapy the number of interventions AE and the influence of HPV parameters such as anal HPV-types viral load and HPV-oncogene-mRNA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None