HPV Infection Clinical Trial
— anal HSIL HIV-Official title:
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)
Verified date | May 2024 |
Source | Frantz Viral Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Active, not recruiting |
Enrollment | 17 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 28, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Anal Dysplasia Clinic MidWest | Chicago | Illinois |
United States | Laser Surgery Care | New York | New York |
United States | Anal Neoplasia and Cancer Research and Education Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Frantz Viral Therapeutics, LLC | Amarex CRO, Anal Dysplasia Clinic MidWest, Laser Surgery Care, University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with Treatment-Emergent Adverse Events (TEAE) | Number of participants who had adverse events, as defined by CTCAE v5.0, related to the study intervention | 12 weeks | |
Other | Number of participants who withdrew from the study due to TEAEs | Number of participants who were withdrawn from the study due to adverse events related to the study drug | 12 weeks | |
Other | Changes in vital signs over the study window | Number of participants who had clinically significant changes in vital signs | 42 weeks | |
Other | Changes in physical examination abnormalities | Number of participants who had clinically significant changes in physical examination abnormalities | 42 weeks | |
Other | Clinically significant changes in ECG between baseline and post dosing | Number of participants who had clinical significant changes in ECG between pre-dosing and post dosing | 8 weeks | |
Primary | Number of subjects with complete and partial response by week 18 | Number of participants who achieve complete or partial response after 4 5-day cycles of artesunate as determined by HRA-directed biopsy(ies) | 18 weeks | |
Secondary | Number of participants who have achieved clearance of detectable human papilloma virus (HPV) over the study window | Number of participants who had HPV strains detected at study entry which become undetectable within the study window | 42 weeks | |
Secondary | Number of participants with complete and partial response after week 18 but over the study window | Number of participants who achieve complete or partial response after week 18, as documented by HRA-directed biopsy(ies) | 30 weeks | |
Secondary | Number of participants who achieve complete and partial response of peri-anal HSIL, following 4 cycles of intra-anal artesunate suppositories, as determined by HRA-directed biopsy | Number of participants who had both peri-anal and intra-anal HSIL, whose peri-anal HSIL achieves complete or partial response following 4 cycles of intra-anal artesunate suppositories | 42 weeks | |
Secondary | Number of participants who undergo complete response who maintain their response over the study window | Number of participants who complete or partial response who maintain this response over the study window | 42 weeks |
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