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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Georgia
Grady Health System (non-CRN)
RECRUITING
Atlanta
Hope Clinic
RECRUITING
Atlanta
Contact Information
Primary
Colleen Kelley, MD, MPH
kelley@emory.edu
404-712-1823
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2028-09
Participants
Target number of participants: 200
Treatments
Experimental: Doxycycline 200mg
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.
Active_comparator: Observation with biological sampling
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.
Related Therapeutic Areas
HIV/AIDS
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Emory University

This content was sourced from clinicaltrials.gov

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