Status:
COMPLETED
Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens
Lead Sponsor:
Emory University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Sexually Transmitted Infection
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief 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...
Detailed Description
Recent studies have demonstrated the potential utility of single-dose oral doxycycline postexposure prophylaxis (Doxy-PEP) against bacterial sexually transmitted infections (STIs). Additional dosing s...
Eligibility Criteria
Inclusion
- 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
- 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 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:
- Hemoglobin (Hgb) ≤ 10 g/dL
- Partial thromboplastin time (PTT) \> 1.5x upper limit of normal (ULN) or international normalised ratio (INR) \> 1.5x ULN
- Platelet count \<100,000
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06545656
Start Date
September 13 2024
End Date
April 29 2025
Last Update
June 27 2025
Active Locations (1)
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1
Hope Clinic
Atlanta, Georgia, United States, 30322