Doxy-Post-exposure Prophylaxis

Sexually Transmitted Diseases Clinical Trial

— DOXY-PEP  

Official title:

Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05853120
• Other study ID #: STUDY00005552
• Secondary ID: 75D30122C14484
• Status: Recruiting
• Phase: Phase 4
• Start date: May 31, 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Emory University
• Contact: Colleen Kelley, MD, MPH
• Phone: 404-712-1823
• Email: colleen.kelley[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Exclusion Criteria:

• Current or chronic history of liver disease

• Continued need for, or use during the 90 days before enrollment, of the following medications:

1. Systemic immunomodulatory agents

2. Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)

3. Chemotherapy or radiation for treatment of malignancy

4. Experimental medications, vaccines, or biologicals

• Intent to use doxycycline or other tetracycline-derived antibiotics during 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:

1. Hgb = 10 g/dL

2. PTT > 1.5x ULN or INR > 1.5x ULN

3. Platelet count <100,000

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

Intervention

Drug:
• Doxycycline
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.

Locations

Country	Name	City	State
United States	Hope Clinic	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in blood doxycycline concentrations in participants taking 5 doses of doxycycline.	Blood samples will be taken at each in person visit	Throughout study up to 3 months after fifth dose
Other	Changes in urine doxycycline concentrations in participants taking 5 doses of doxycycline.	Urine samples will be taken at each in person visit	Throughout study up to 3 months after fifth dose
Other	Changes in doxycycline concentrations in throat secretions in participants taking 5 doses of doxycycline.	Self-collected swab samples will be collected 24 hours after administration of	Throughout study up to 3 months after fifth dose
Other	Changes in doxycycline concentrations in vaginal secretions in participants taking 5 doses of doxycycline.	Self-collected vaginal swabs will be collected at each in person visit	Throughout study up to 3 months after fifth dose
Other	Changes in doxycycline concentrations in rectal secretions in participants taking 5 doses of doxycycline.	Self-collected and staff assisted vaginal swabs will be collected at each in person visit	Throughout study up to 3 months after fifth dose
Other	Changes in doxycycline concentrations in penile secretions in participants taking 5 doses of doxycycline.	Staff-Assisted urethral and glans swabs will be collected	Throughout study up to 3 months after fifth dose
Primary	Doxycycline concentrations in rectal tissues	Self-collected swabs and rectal biopsies will be collected 24 hours after administration of the initial dose of doxycycline	Day 2
Primary	Doxycycline concentrations in vaginal tissues	Self-collected swabs and vaginal biopsies will be collected 24 hours after administration of the initial dose of doxycycline	Day 2
Primary	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	Day 15
Primary	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	Day 15