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Doxy-Post-exposure Prophylaxis (DOXY-PEP)

Primary Purpose

Sexually Transmitted Diseases

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Doxycycline
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring Prevention, STI, Post-exposure prophylaxis, HIV, PEP

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 18-59 years Assigned male sex or female sex at birth In good general health Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study For HIV-positive people, on stable antiretroviral therapy with an undetectable viral load and CD4 count> 300ul/ml Willing to use condoms consistently for the duration of the study Able to provide informed consent No plans for relocation in the next 4 months Not pregnant and does not plan on getting pregnant for the duration of the study Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure Willing to use study products as directed Creatinine clearance >60 ml/min Exclusion Criteria: Currently infected with hepatitis virus and/ or has liver disease Current or chronic history of kidney disease or CrCl<60 ml/min Continued need for, or use during the 90 days prior to enrollment, of the following medications: Systemic immunomodulatory agents Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) Chemotherapy or radiation for treatment of malignancy Experimental medications, vaccines, or biologicals Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements Known allergic reaction to study drugs. Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to: Hgb ≤ 10 g/dL PTT > 1.5x ULN or INR > 1.5x ULN Platelet count <100,000

Sites / Locations

  • Hope ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Doxycycline 100 mg

Doxycycline 200 mg

Arm Description

Doxycycline 100mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 1

Doxycycline - 200 mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 10

Outcomes

Primary Outcome Measures

Doxycycline concentrations in rectal tissues
Self-collected swabs and rectal biopsies will be collected 24 hours after administration of the initial dose of doxycycline
Doxycycline concentrations in vaginal tissues
Self-collected swabs and vaginal biopsies will be collected 24 hours after administration of the initial dose of doxycycline
Doxycycline concentrations in rectal tissues after the fifth dose of doxycycline
Self-collected swabs and rectal biopsies will be collected 24 hours after administration of the fifth dose of doxycycline
Doxycycline concentrations in vaginal tissues collected 24 hours after the fifth dose of doxycycline
Self-collected swabs and vaginal biopsies will be collected 24 hours after administration of the fifth dose of doxycycline

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
June 8, 2023
Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05853120
Brief Title
Doxy-Post-exposure Prophylaxis
Acronym
DOXY-PEP
Official Title
Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
Prevention, STI, Post-exposure prophylaxis, HIV, PEP

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline 100 mg
Arm Type
Active Comparator
Arm Description
Doxycycline 100mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 1
Arm Title
Doxycycline 200 mg
Arm Type
Active Comparator
Arm Description
Doxycycline - 200 mg Participants will receive the first assigned dose of Doxycycline at the clinic on days 0 and 3 at the clinic. The other three doses of the medication will be taken at home on days 7 and 10
Intervention Type
Drug
Intervention Name(s)
Doxycycline
Other Intervention Name(s)
DOX
Intervention Description
Doxycycline is used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections. Doxycycline (DOX) will be given orally at 100 and 200 mg doses.
Primary Outcome Measure Information:
Title
Doxycycline concentrations in rectal tissues
Description
Self-collected swabs and rectal biopsies will be collected 24 hours after administration of the initial dose of doxycycline
Time Frame
Day 2
Title
Doxycycline concentrations in vaginal tissues
Description
Self-collected swabs and vaginal biopsies will be collected 24 hours after administration of the initial dose of doxycycline
Time Frame
Day 2
Title
Doxycycline concentrations in rectal tissues after the fifth dose of doxycycline
Description
Self-collected swabs and rectal biopsies will be collected 24 hours after administration of the fifth dose of doxycycline
Time Frame
Day 15
Title
Doxycycline concentrations in vaginal tissues collected 24 hours after the fifth dose of doxycycline
Description
Self-collected swabs and vaginal biopsies will be collected 24 hours after administration of the fifth dose of doxycycline
Time Frame
Day 15
Other Pre-specified Outcome Measures:
Title
Changes in blood doxycycline concentrations in participants taking 5 doses of doxycycline.
Description
Blood samples will be taken at each in person visit
Time Frame
Throughout study up to 3 months after fifth dose
Title
Changes in urine doxycycline concentrations in participants taking 5 doses of doxycycline.
Description
Urine samples will be taken at each in person visit
Time Frame
Throughout study up to 3 months after fifth dose
Title
Changes in doxycycline concentrations in throat secretions in participants taking 5 doses of doxycycline.
Description
Self-collected swab samples will be collected 24 hours after administration of
Time Frame
Throughout study up to 3 months after fifth dose
Title
Changes in doxycycline concentrations in vaginal secretions in participants taking 5 doses of doxycycline.
Description
Self-collected vaginal swabs will be collected at each in person visit
Time Frame
Throughout study up to 3 months after fifth dose
Title
Changes in doxycycline concentrations in rectal secretions in participants taking 5 doses of doxycycline.
Description
Self-collected and staff assisted vaginal swabs will be collected at each in person visit
Time Frame
Throughout study up to 3 months after fifth dose
Title
Changes in doxycycline concentrations in penile secretions in participants taking 5 doses of doxycycline.
Description
Staff-Assisted urethral and glans swabs will be collected
Time Frame
Throughout study up to 3 months after fifth dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18-59 years Assigned male sex or female sex at birth In good general health Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study For HIV-positive people, on stable antiretroviral therapy with an undetectable viral load and CD4 count> 300ul/ml Willing to use condoms consistently for the duration of the study Able to provide informed consent No plans for relocation in the next 4 months Not pregnant and does not plan on getting pregnant for the duration of the study Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure Willing to use study products as directed Creatinine clearance >60 ml/min Exclusion Criteria: Currently infected with hepatitis virus and/ or has liver disease Current or chronic history of kidney disease or CrCl<60 ml/min Continued need for, or use during the 90 days prior to enrollment, of the following medications: Systemic immunomodulatory agents Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators) Chemotherapy or radiation for treatment of malignancy Experimental medications, vaccines, or biologicals Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements Known allergic reaction to study drugs. Significant laboratory abnormalities at baseline visit for rectal biopsies, including but not limited to: Hgb ≤ 10 g/dL PTT > 1.5x ULN or INR > 1.5x ULN Platelet count <100,000
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Kelley, MD, MPH
Phone
404-712-1823
Email
colleen.kelley@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Kelley, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hope Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Kelley, MD, MPH
Phone
404-712-1823
Email
colleen.kelley@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results published for this study (including text, tables, figures, and appendices), will be made available for sharing, after de-identification.
IPD Sharing Time Frame
The research team will share de-identified participant data after the primary manuscript publication.
IPD Sharing Access Criteria
Interested investigators can request deidentified data by email for secondary data analyses and/or meta-analyses.

Learn more about this trial

Doxy-Post-exposure Prophylaxis

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