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This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 1 | Experimental | Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Dose 2 | Experimental | Topical ABI-1968 Cream applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Dose 3 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Dose 4 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Dose 5 | Experimental | New Topical ABI-1968 Formulation applied at Day 1, Day 8, Day 15 and Day 22 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical ABI-1968 | Drug | Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety & Tolerability of ABI-1968 for the treatment of cHSIL | Number of Adverse Events related to treatment | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to ABI-1968 Topical Cream following topical application to the cervix. | Plasma concentrations of ABI-1968 over time | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Histopathology of areas with biopsy-proven disease | Number of subjects with complete and or partial regression of cHSIL by Histopathology | 42 days |
| Changes in HPV viral load following multiple doses of ABI-1968 Topical Cream |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Bloemfontein | Free State | 9301 | South Africa |
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Changes from baseline in HPV viral load following multiple doses of ABI-1968 Topical Cream
| 42 days |
| ID | Term |
|---|---|
| D000081483 | Squamous Intraepithelial Lesions |
| D002583 | Uterine Cervical Neoplasms |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011230 | Precancerous Conditions |
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