Daily Doxycycline to Inform Sexually Transmitted Infection Prophylaxis Regimens

Completed · Phase 4

Conditions studied: Sexually Transmitted Infection

In brief

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).

Key facts

Study ID

NCT06545656

Run by

Emory University

People needed

24

Starts

2024-09-13

Expected to finish

2025-04-29

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hope Clinic — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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