Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853120
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-05-02
Brief Title:
Doxy-Post-exposure Prophylaxis
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Doxy-PEP Dose-Ranging Study of Persons Receiving Doxycycline
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOXY-PEP
Brief Summary:
The goal of this project is to collect data regarding the ability of various oral doses of doxycycline to penetrate mucosal tissues in men and women to inform the combination of doxycycline with antiretrovirals ARVs for the development of single-dose event-driven multipurpose prevention strategies to protect against HIV and sexually transmitted infections STIs
This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs
The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures
Recruitment Both face-to-face and online engagements will be conducted to recruit study participants Face-to-face locations include bars and nightclubs community organizations serving study populations sports events and community venues and online engagements include dating sites social networks and craigslist amongst other social medial platforms
This study is of importance in the field of research because it allows the exploration of new dosing strategies that would permit a single event-driven oral dose of medications that could provide protection from HIV as well as other STIs
The study population that this study seeks to enroll are healthy people assigned male or female sex at birth and not using gender-affirming hormone therapy and are willing to undergo study procedures
Recruitment Both face-to-face and online engagements will be conducted to recruit study participants Face-to-face locations include bars and nightclubs community organizations serving study populations sports events and community venues and online engagements include dating sites social networks and craigslist amongst other social medial platforms
Detailed Description:
The incidence of bacterial STIs is increasing and studies have recently shown that Doxy-PEP can reduce the incidence of bacterial STIs among men who have sex with men MSM and Doxy-PEP is being explored for STI prevention among women
A better understanding of mucosal drug penetration of doxycycline will inform the design of future studies to prevent STIs in various populations The purpose of this study is to understand how well doxycycline taken by mouth gets to the tissues of the rectum and vagina Researchers think doxycycline could be used to treat sexually transmitted infections STIs caused by bacteria To understand better they want to see how well doxycycline reaches the tissues affected by STIs
The study procedures include the collection of past and present medical history and biological specimen sampling such as blood rectal and vaginal fluids tissue biopsies and urine Study participants will also be administered an investigational agent doxycycline not yet approved for this indication
The duration of this clinical trial for study participants will be approximately 8 weeks
A better understanding of mucosal drug penetration of doxycycline will inform the design of future studies to prevent STIs in various populations The purpose of this study is to understand how well doxycycline taken by mouth gets to the tissues of the rectum and vagina Researchers think doxycycline could be used to treat sexually transmitted infections STIs caused by bacteria To understand better they want to see how well doxycycline reaches the tissues affected by STIs
The study procedures include the collection of past and present medical history and biological specimen sampling such as blood rectal and vaginal fluids tissue biopsies and urine Study participants will also be administered an investigational agent doxycycline not yet approved for this indication
The duration of this clinical trial for study participants will be approximately 8 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 75D30122C14484 | OTHER_GRANT | Centers for Disease Control and Prevention | None |