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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05853120
Other study ID # STUDY00005552
Secondary ID 75D30122C14484
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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