Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
United States24 participantsStarted 2024-09-13
Plain-language summary
The goal of this project is to collect data regarding the concentrations of doxycycline in mucosal tissues after daily dosing for 7 days in people assigned male sex at birth (AMAB) and assigned female sex at birth (AFAB) to inform future studies of doxycycline to protect against bacterial sexually transmitted infections (STIs).
Who can participate
Age range18 Years – 59 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 cluster of differentiation 4 (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 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 stud…
What they're measuring
1
Doxycycline Concentration in Rectal Tissue
Timeframe: 24 hours after last dose (Hour 24/Day 1)
2
Doxycycline Concentration in Vaginal Tissue
Timeframe: 24 hours after last dose (Hour 24/Day 1)