Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06206564
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-01-03
Brief Title:
Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants
Sponsor:
Frantz Viral Therapeutics LLC
Organization:
Frantz Viral Therapeutics LLC
Study Overview
Official Title:
A Phase II Double Blind Placebo-controlled Randomized Trial of Artesunate Ointment for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions Anal HSIL
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ART-AIN IIB-2
Brief Summary:
This is a phase II double blind placebo-controlled randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions anal HSIL
Detailed Description:
Eligible participants in this study are randomized 21 to receive either artesunate or placebo ointment for the treatment of anal HSIL Both groups receive four 5-day cycles of ointment at weeks 0 2 4 and 6 Participants are followed closely with anoscopy or high resolution anoscopy HRA at weeks 8 18 30 and 42 After the week 18 HRA visit participants who have at least partial response will be followed with HRA at week 30
Participants who are found to be non-responders at week 18 will undergo standard of care ablation
Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures
Primary Objective To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL 18 weeks
Secondary Objectives
Efficacy
To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window
Safety
To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL
Participants who are found to be non-responders at week 18 will undergo standard of care ablation
Participants who are found to have anal HSIL at weeks 30 or 42 will be followed according to standard of care procedures
Primary Objective To evaluate the complete and partial histopathologic response to four 5-day cycles of artesunate ointment in adult patients with biopsy-proven HPV-associated intra-anal HSIL 18 weeks
Secondary Objectives
Efficacy
To evaluate the viral clearance after four 5-day cycles of artesunate ointment To evaluate complete and partial intra-anal response To evaluate complete and partial peri-anal response To evaluate persistence of response throughout the study window
Safety
To evaluate the safety of artesunate ointment for the treatment of intra-anal HSIL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None