Clinical trial · Interventional
Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
A Phase I Study of Intra-Anally Administered Artesunate in Patients With High-Grade Anal Intraepithelial Neoplasia (AIN 2/3)
NCT03100045CI-TRIAL-00054835ART-AINcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This open label study investigates a novel non-surgical approach to the treatment of HPV-associated anal intraepithelial neoplasia, using Artesunate suppositories.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIN2/3 | — | UNRESOLVED | — |
| Alternative Treatment | — | UNRESOLVED | — |
| Anal Dysplasia | Anal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Artesunate | — | UNRESOLVED | — |
| HPV-Related Anal Intraepithelial Neoplasia | — | UNRESOLVED | — |
| Human Papilloma Virus | — | UNRESOLVED | — |
| Precancerous Conditions | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate Suppositories | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- ART 200 mg, 2 cycles
- description
- Two five-day cycles of Artesunate suppositories, 200 mg/day
- interventionNames
- Drug: Artesunate Suppositories
- type
- EXPERIMENTAL
- label
- ART 200 mg, 3 cycles
- description
- Three five-day cycles of Artesunate suppositories, 200 mg/day
- interventionNames
- Drug: Artesunate Suppositories
- type
- EXPERIMENTAL
- label
- ART 400 mg, 2 cycles
- description
- Two five-day cycles of Artesunate suppositories, 400 mg/day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Biopsy-confirmed high-grade anal dysplasia (AIN 2, AIN 3, HSIL) by high resolution anoscopy (HRA) * Female of childbearing potential: negative urine pregnancy test * Able to provide informed consent * Patients who have the ability to collaborate with planned follow-up (transportation, compliance history, etc.). * Weight ≥50 kg. Exclusion Criteria: * Diagnosis of low-grade anal dysplasia (AIN 1, LSIL) by high resolution anoscopy * Known anal, vulvar, cervical, or penile cancer * CD4 count \< 200 at the time of consideration for entry into this study * Unable to provide informed consent * Currently receiving systemic chemotherapy or radiation therapy for another cancer. * Patients who are on medical treatment with systemic immunosuppressants or steroids (e.g., active autoimmune disease) * Extensive anal condyloma precludes the ability for the clinician to visualize HSIL during HRA
References
Publications (0)
Data not yet available
No reference posted for this study.