Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03603808 | VGX-3100 and Electroporation in Treating Patients With HIV-Positive High-Grade Anal Lesions | PHASE2 | COMPLETED | 44 | — | — | Sep 21, 2018 | Jun 17, 2025 | Apr 29, 2026 | 8 | United States, Puerto Rico |
Defined as histopathological regression of human papillomavirus (HPV)-16 and/or 18-positive anal high grade squamous intraepithelial neoplasia (HSIL) to low grade squamous intraepithelial neoplasia (LSIL) \[anal intraepithelial neoplasia (AIN)1\] or normal.
| Arm | Type | Description |
|---|---|---|
| Treatment (VGX-3100, electroporation) | EXPERIMENTAL | Patients receive HPV DNA plasmids therapeutic vaccine VGX-3100 IM and then undergo electroporation over 10 seconds for 4 doses in week 0, 4, 12, and 24 in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Electroporation | DEVICE | Undergo electroporation |
| HPV DNA Plasmids Therapeutic Vaccine VGX-3100 | BIOLOGICAL | Given IM |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
Inclusion Criteria: * Biopsy-proven intra-anal or per-HSIL at baseline (anal intraepithelial neoplasia \[AIN\]2 with a positive p16 stain, PAIN2-3, AIN2-3, or PAIN3/AIN3) * At least one focus of HSIL must be large enough to be monitored for response, i.e., not completely removed after the screening...