Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545656
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Daily Doxy Study of Persons Receiving Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth AMAB and assigned female sex at birth AFAB to inform future studies of doxycycline to protect against bacterial sexually transmitted infections STIs
Detailed Description:
Recent studies have demonstrated the potential utility of single-dose oral doxycycline postexposure prophylaxis Doxy-PEP against bacterial sexually transmitted infections STIs Additional dosing strategies are being explored that would also provide protection from bacterial STIs However the pharmacokinetics of daily doxycycline and specifically the effect of this dosing on effective drug levels in mucosal tissues is underexplored A previous pilot study conducted by the Division of human immunodeficiency virus HIV Prevention DHP Laboratory Branch at the Centers for Disease Control and Prevention CDC examined the ability of a single 100mg oral dose of doxycycline to penetrate the vaginal and rectal mucosa However data regarding daily doxycycline doses and accumulation of doxycycline with multiple doses are lacking
The purpose of this project is to collect data regarding the ability of daily oral doxycycline taken for 7 days to concentrate in mucosal tissues in people assigned male sex at birth AMAB and assigned female sex at birth AFAB Results from this study will be compared to results of the previous pilot studies conducted by the DHP Laboratory Branch at CDC
Healthy people assigned male or female sex at birth will take the first dose of doxycycline during the enrollment visit Hour -144Day -6 then will take the next 5 doses at home one per day for the next 5 days After 6 consecutive days of dosing study participants will have samples collected Hour 0Day 0 and then will take the final dose Rectal and vaginal swab samples will be obtained 2 to 4 hours after the final dose of doxycycline Rectal and vaginal biopsy tissue will be collected 24 hours after the last dose
The purpose of this project is to collect data regarding the ability of daily oral doxycycline taken for 7 days to concentrate in mucosal tissues in people assigned male sex at birth AMAB and assigned female sex at birth AFAB Results from this study will be compared to results of the previous pilot studies conducted by the DHP Laboratory Branch at CDC
Healthy people assigned male or female sex at birth will take the first dose of doxycycline during the enrollment visit Hour -144Day -6 then will take the next 5 doses at home one per day for the next 5 days After 6 consecutive days of dosing study participants will have samples collected Hour 0Day 0 and then will take the final dose Rectal and vaginal swab samples will be obtained 2 to 4 hours after the final dose of doxycycline Rectal and vaginal biopsy tissue will be collected 24 hours after the last dose
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