Got Doxy- 'Flipping the Script' on STI PEP
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorEmory University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Severe/uncontrolled comorbidities that could influence immune outcomes (e.g., diabetes, hypertension, co-infections), as assessed by the investigator.
History of inflammatory bowel disease (IBD) or other inflammatory, infiltrative, infectious, or vascular condition involving the lower GI tract that, in the judgment of the investigators, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel.
Known allergy to doxycycline
Use of any antibiotics within 3 months before screening
Trial design
Treatments tested in this trial
- Doxycycline monohydrate 200 mg
- Observation
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov