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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07601074 | A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV) | PHASE2 | NOT YET_RECRUITING | 118 | — | — | Jun 1, 2026 | Dec 1, 2027 | Jun 2, 2026 | 1 | United States |
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment
| Arm | Type | Description |
|---|---|---|
| DARE-HPV-LD 14 day | ACTIVE_COMPARATOR | 14 day administration of DARE-HPV low dose |
| DARE-HPV-LD 21 day | ACTIVE_COMPARATOR | 21 day administration of DARE-HPV low dose |
| DARE-HPV-HD 14 day | ACTIVE_COMPARATOR | 14 day administration of DARE-HPV high dose |
| DARE-HPV-HD 21 day | ACTIVE_COMPARATOR | 21 day administration of DARE-HPV high dose |
| Placebo 14 day | NO_INTERVENTION | 14 day administration of placebo product |
| Placebo 21 day | NO_INTERVENTION | 21 day administration of placebo product |
| Name | Type | Description |
|---|---|---|
| Lopinavir / ritonavir | DRUG | A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule. |
Inclusion Criteria: 1. Provision of written informed consent prior to any study-specific procedures. 2. Premenopausal women aged 22-50 years inclusive at the time of screening visit. 3. Positive result for genital hrHPV (types 16, 18, or 'other') on at least 2 tests over the span of at least 12 mon...