Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560684
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PHASE 2 CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR-BASED PREP EVALUATING EXTENDED SAFETY ACCEPTABILITY AND PHARMACOKINETICSPHARMACODYNAMICS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2 multi-site two-period open label randomized crossover Period 1 and 2 study Participants are randomized 11 to one of two 8-week on-demand product sequences - TFV douche then oral FTDF or oral FTDF then TFV douche - with a 2 to 4-week washout period in between Domains of safety acceptability adherence and PKPD sub-study only are assessed for each product
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None