NCT07215325|RecruitingPhase 4FDA Drug
Got Doxy- 'Flipping the Script' on STI PEP
The Effects of Doxycycline on Inflammation and the Microbiome: 'Flipping the Script' on STI PEP
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Sponsor study identifier
Secondary identifiers
OTHER · Emory IRB
interventional
200
1 country
2
Study Start
October 13, 2025
Actual (reported)Primary Completion
April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 3, 2025
Actual (reported)October 10, 2025
Actual (reported)October 13, 2025
Actual (reported)April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Composite inflammation score
A composite inflammation score in the blood and rectal secretions before and after doxy-PEP will be calculated for each participant: +1 point for each proinflammatory cytokine (IP-10, IL-1β, tumor necrosis factor (TNF-α), Monocyte chemoattractant protein-1 (MCP-1), IL-17A, IL-6, interferon (IFN-γ), IL-12p70, IL-8) that was in the top quartile concentration and -1 point for each anti-inflammatory cytokine (IL-4, IL-10), T-cell growth factor (TGF-β1) that was in the top quartile concentration for a maximum score of 9 and minimum score of -3.
Baseline and 12 weeks after the start of doxycycline administration
Tetracycline (TCN) Gene Abundance
Baseline and 12 weeks after the start of doxycycline administration
Estimated mass of antimicrobial resistance (AMR) Genes
Baseline and 12 weeks after the start of doxycycline administration
Males with HIV infection on antiretroviral therapy or without HIV infection on HIV pre-exposure prophylaxis who are not taking doxy-PEP will be enrolled and randomized to take 12 weeks of doxycycline 200 mg by mouth three times weekly. Blood and rectal mucosal samples will be collected before the initiation of doxycycline.
Males with HIV infection on antiretroviral therapy or without HIV infection on HIV pre-exposure prophylaxis who are not taking doxy-PEP will receive standard of care and will undergo biological sampling.
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.
Grady Health System (non-CRN)
Atlanta, Georgia, 30322, United States
Hope Clinic
Atlanta, Georgia, 30322, United States
Colleen Kelley, MD, MPH
Emory University
First Submitted
October 3, 2025
First Posted
October 10, 2025
Study Start
October 13, 2025
Actual (reported)Primary Completion
April 13, 2029
EstimatedParrying the Pitfalls of PrEP: Project PEACH
Standard of care. Blood and rectal mucosal samples.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 13, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 30, 2026
Record last verified: 2026-04
Individual participant data that underlie the results published for this study will be made available for sharing after de-identification.
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Source: ClinicalTrials.gov.
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