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RECRUITING
NCT07215325
PHASE4

Got Doxy- 'Flipping the Script' on STI PEP

Sponsor: Emory University

View on ClinicalTrials.gov

Summary

This study is being done to test the effects of doxycycline on inflammation and the bacteria in the body in people with HIV and in people on HIV pre-exposure prophylaxis. This drug is approved by the Food and Drug Administration (FDA) for the treatment of bacterial infections. The study team will investigate whether the drug has additional effects on inflammation or on the bacteria that live in the body.

Official title: The Effects of Doxycycline on Inflammation and the Microbiome: 'Flipping the Script' on STI PEP

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-10-22

Completion Date

2028-09

Last Updated

2025-12-12

Healthy Volunteers

Yes

Interventions

DRUG

Doxycycline monohydrate 200 mg

Doxycycline monohydrate 200 mg (two 100 mg tablets) is used to treat or prevent infections that are strongly suspected to be caused by bacteria. Doxycycline monohydrate is an antimicrobial drug indicated for the treatment of bacterial infections, including sexually transmitted diseases. Centers for Disease Control and Prevention (CDC) recommends its use as post-exposure prophylaxis (PEP). Blood and rectal mucosal samples will be collected before doxycycline is initiated. Participants will be instructed to take 200 mg of doxycycline by mouth every Monday, Wednesday, and Friday. Additional doses of doxycycline will be permitted on other days if sex without a condom occurs per CDC guidance. After 12 weeks of at least three-weekly doxycycline, blood and rectal mucosal samples will be collected for immunologic and microbiome/resistome assays.

OTHER

Observation

Standard of care. Blood and rectal mucosal samples.

Locations (2)

Grady Health System (non-CRN)

Atlanta, Georgia, United States

Hope Clinic

Atlanta, Georgia, United States