Clinical Trials Logo

Clinical Trial Summary

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)


Clinical Trial Description

Eligible participants in this study are randomized 2:1 to receive either artesunate or placebo suppositories for the treatment of anal HSIL. Both groups receive four 5-day cycles of suppositories, at weeks 0, 2, 4, and 6. At least two of the dosing visits are done in person. The remaining dosing visits may be done as telehealth visits (suppositories are mailed to the patient's home). 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 suppositories 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 suppositories in adults with biopsy-proven HPV-associated intra-anal anal HSIL over the study window (42 weeks) - To evaluate complete and partial intra-anal histopathologic response after the week 18 time point but over the study window (30 weeks). - To evaluate complete and partial peri-anal histopathologic response following artesunate suppositories over the course of the study (42 weeks). - To evaluate persistence of response throughout the study window (42 weeks) Safety: To evaluate the safety of artesunate suppositories for the treatment of intra-anal HSIL. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05555862
Study type Interventional
Source Frantz Viral Therapeutics, LLC
Contact
Status Active, not recruiting
Phase Phase 2
Start date February 10, 2023
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04098744 - Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3) Phase 2
Completed NCT04083196 - A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years Phase 1
Completed NCT04191967 - Thermocoagulation for Treatment of Precancerous Cervical Lesions N/A
Withdrawn NCT04430907 - HPV Vaccine in Postpartum Women
Recruiting NCT02593968 - Yallaferon in Chinese Population Phase 2
Completed NCT04711265 - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Completed NCT02263378 - A New Supplement for the Immune Response to HPV Infection N/A
Completed NCT05234112 - Prevention and Screening Towards Elimination of Cervical Cancer N/A
Completed NCT04590521 - HPV Vaccine Immunity in High-risk Women Phase 4
Recruiting NCT05829629 - Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women Phase 1
Recruiting NCT06052033 - Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection N/A
Recruiting NCT05051852 - HPV Viral Load in Predicting the Prognosis of LSIL
Completed NCT04155294 - Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
Active, not recruiting NCT06452004 - Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC) N/A
Completed NCT06177236 - Clinic or Self-Sampling for Cervical Cancer Screening N/A
Active, not recruiting NCT04794660 - The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa" Phase 3
Recruiting NCT05509413 - DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections N/A
Recruiting NCT06137950 - Interferon Alpha Therapy for Cervical CINI and HPV Infection Phase 1
Recruiting NCT04171505 - Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
Active, not recruiting NCT05524025 - The SPOT-HPV Study