This study is intended to explore and evaluate the pharmacodynamics and clinical efficacy of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions
This study is intended to explore clinical efficacy and safety/tolerability of ICVT as a potential treatment for benign and premalignant HPV-induced genital lesions in immunocompetent and immunosuppressed patients. This includes 3 different patient populations: i) immunocompetent patients with anogenital warts (AGWs), ii) immunocompromised patients with anogenital warts and iii) immunocompromised patients with vulvar high grade squamous intraepithelial neoplasia (HSIL), formerly referred to as usual type vulvar intraepithelial neoplasia (uVIN). Since digoxin / furosemide ICVT's mode of action is in part independent of the immune system and directly targeted to eradicate the causative HPV, we hypothesize this therapy to be of value in this specific group of individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
LUMC/Centre For Human Drug Research
Leiden, Netherlands
Lesion (vulvar HSIL or wart) size reduction
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Change in patient-reported outcomes
Time frame: Through study completion, up to 20 weeks
HPV viral load assessment
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Change in the HPV viral load
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Mean HPV viral load
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Histology (regression of vulvar HSIL or AGWs to no dysplasia, HPV genotyping)
Time frame: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)
Local immunity status
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Percentage clearance of vulvar HSIL lesions
For vulvar HSIL cohort
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Proportion of patients with all vulvar HSIL lesions cleared
For vulvar HSIL cohort
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Histology (regression of vulvar HSIL to no dysplasia)
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For vulvar HSIL cohort
Time frame: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)
Histological recurrence in the Part 1 follow-up period
For vulvar HSIL cohort
Time frame: Day 84, 126
Percentage clearance of genital warts
For genital wart cohort
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Proportion of patients with all genital warts cleared
For genital wart cohort
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
Clinical recurrence in the Part 1 follow-up period
For genital wart cohort
Time frame: Day 84, 126
Adverse event collection to assess safety/tolerability of CLS003
Time frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study), and as volunteered by patient