Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DARE-HPV · 1 trial · 2 indications
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...