The Effects of Doxycycline on Inflammation and the Microbiome: 'Flipping the Script' on STI PEP
Emory University
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.
Description
This project aims to determine the potential anti-inflammatory and microbiome effects of doxycycline when used as post-exposure prophylaxis (Doxy PEP) for sexually transmitted infections (STIs). This study is important in the field of research because it allows the investigators to define the systemic and gut anti-inflammatory, microbiome, and resistome effects of doxycycline when used as post-exposure prophylaxis (Doxy PEP) for sexually transmitted infections. The study population that this study seeks to enroll consists of healthy people assigned male at birth, with and without HIV, who are…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * Age \>18 years * Assigned male sex at birth * Good general health as assessed by a clinician at the screening study visit * For people with HIV, on suppressive antiretroviral therapy for at least 6 months with the most recent viral load documented \<50 copies/ml and the most recent cluster of differentiation 4 (CD4)\>300cells/ul * For people without HIV, taking oral daily, oral on-demand, or injectable pre-exposure prophylaxis for at least 3 months at the time of enrollment, with plans to continue for the duration of the study * Additional criteria apply Exclusion Crite…
Interventions
- DrugDoxycycline 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.
- OtherObservation
Standard of care. Blood and rectal mucosal samples.
Locations (2)
- Grady Health System (non-CRN)Atlanta, Georgia
- Hope ClinicAtlanta, Georgia