Clinical trial NCT05853120: Doxy-Post-exposure Prophylaxis
Official title: Doxy-PEP: Dose-Ranging Study of Persons Receiving Doxycycline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sexually Transmitted Diseases
Keywords: Prevention
STI
Post-exposure prophylaxis
HIV
PEP
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2023-05-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

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

Primary outcomes:
measure: Doxycycline concentrations in rectal tissues
timeFrame: Day 2
measure: Doxycycline concentrations in vaginal tissues
timeFrame: Day 2
measure: Doxycycline concentrations in rectal tissues after the fifth dose of doxycycline
timeFrame: Day 15
measure: Doxycycline concentrations in vaginal tissues collected 24 hours after the fifth dose of doxycycline
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
measure: Changes in blood doxycycline concentrations in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
measure: Changes in urine doxycycline concentrations in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
measure: Changes in doxycycline concentrations in throat secretions in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
measure: Changes in doxycycline concentrations in vaginal secretions in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
measure: Changes in doxycycline concentrations in rectal secretions in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
measure: Changes in doxycycline concentrations in penile secretions in participants taking 5 doses of doxycycline.
timeFrame: Throughout study up to 3 months after fifth dose
Locations:
city: Atlanta
country: United States
facility: Hope Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Colleen Kelley, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: