Clinical trial · Interventional
Artesunate Suppositories for the Treatment of HIV-negative Patients With Intra-anal HSIL
A Phase II Double Blind, Placebo-controlled, Randomized Trial of Artesunate Suppositories for the Treatment of HIV-negative Patients With Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)
NCT05555862CI-TRIAL-00089866anal HSIL HIV-active not recruitingPhase 2ClinicalTrials.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 is a phase II double blind, placebo-controlled, randomized study of Artesunate suppositories for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AIN 2/3 | — | UNRESOLVED | — |
| Anal Dysplasia | Anal Intraepithelial Neoplasia | ALIAS | 0.90 |
| Anal High Grade Squamous Intraepithelial Lesion | — | UNRESOLVED | — |
| Anal Precancerous Condition | Anal Intraepithelial Neoplasia | ALIAS | 0.90 |
| HPV Disease | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artesunate | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Artesunate suppositories
- description
- Four 5-day cycles of artesunate suppositories
- interventionNames
- Drug: Artesunate
- type
- PLACEBO_COMPARATOR
- label
- Placebo suppositories
- description
- Four 5-day cycles of placebo suppositories
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Number of subjects with complete and partial response by week 18
- timeFrame
- 18 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult men and women age ≥ 18 years * Capable of informed consent * Biopsy-confirmed intra-anal high-grade dysplasia (AIN 2, AIN 3, anal HSIL) by HRA. Patients must have residual anal HSIL lesions after diagnostic biopsies, as documented by HRA. This includes patients who are newly diagnosed with anal HSIL as well as those who have recurrent anal HSIL after medical therapy or surgical therapy. Patients who have intra-anal HSIL and also have peri-anal HSIL may be enrolled in the study. * Women of childbearing potential agree to use birth control for the duration of the study. * Laboratory values at Screening of: 1. Serum alanine transaminase (SGPT/ALT) \< 5 x upper limit of normal (ULN) 2. Serum aspartate transaminase (SGOT/AST) \< 5 x ULN 3. Serum Bilirubin (total) \< 2.5 x ULN 4. Serum Creatinine ≤ 1.5 x ULN * Electrocardiogram (ECG) with no clinically significant findings as assessed by the Investigator. * Weight ≥ 50kg Exclusion Criteria: * Pregnant and nursing women * Diagnosis of low-grade anal dysplasia (AIN 1, LSIL), without the concomitant diagnosis of anal HSIL, by HRA * Concurrent anal, vulvar, cervical, or penile cancer * HIV seropositivity * 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) * Concomitant use of strong Uridine glucuronyl transferases (UGT) inhibitors * Concomitant use of imiquimod or 5-fluorouracil (5-FU) for the duration of the study
References
Publications (0)
Data not yet available
No reference posted for this study.