[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609495":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":42,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":42,"enrollmentInfo":86,"targetDuration":42,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":47,"whyStopped":42,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Emory University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Doxycycline 200mg","EXPERIMENTAL","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.\n\nBlood and rectal mucosal samples will be collected before the initiation of doxycycline.",[13],"Drug: Doxycycline monohydrate 200 mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Observation with biological sampling","ACTIVE_COMPARATOR","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.",[19],"Other: Observation",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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).\n\nBlood 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\u002Fresistome assays.",[9],[27],"Doxycycline",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Observation","Standard of care. Blood and rectal mucosal samples.",[15],[33],"Standard of Care",[35],{"name":36,"affiliation":5,"role":37},"Colleen Kelley, MD, MPH","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","404-712-1823",null,"kelley@emory.edu",[45,62],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Grady Health System (non-CRN)","RECRUITING","Atlanta","Georgia","30322","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-84.38798,33.749,{"lat":57,"lon":56},[60],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":61},"colleen.kelley@emory.edu",{"facility":63,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Hope Clinic",{"type":54,"coordinates":65},[56,57],{"lat":57,"lon":56},[68],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":61},{"type":37,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Colleen Kelley","Professor of Medicine",[73],{"name":74,"class":75},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100609495","phase-4-got-doxy--flipping-the-script-on-sti-pep-100609495",false,"NCT07215325","Got Doxy- 'Flipping the Script' on STI PEP","The Effects of Doxycycline on Inflammation and the Microbiome: 'Flipping the Script' on STI PEP","Inclusion Criteria:\n\n* Age \\>18 years\n* Assigned male sex at birth\n* Good general health as assessed by a clinician at the screening study visit\n* For people with HIV, on suppressive antiretroviral therapy for at least 6 months with the most recent viral load documented \\\u003C50 copies\u002Fml and the most recent cluster of differentiation 4 (CD4)\\>300cells\u002Ful\n* 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\n* Additional criteria apply\n\nExclusion Criteria:\n\n* Severe\u002Funcontrolled comorbidities that could influence immune outcomes (e.g., diabetes, hypertension, co-infections), as assessed by the investigator.\n* 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.\n* Known allergy to doxycycline\n* Use of any antibiotics within 3 months before screening\n* Significant lab abnormalities at baseline visit for rectal biopsies,\n* Continued need for the following medications during the study:\n\n  1. Aspirin\n  2. Warfarin, heparin (LMW or unfractionated), platelet aggregation inhibitors, or fibrinolytic agents\n  3. Any form of rectally administered agent besides products (lubricants or douching) used for sexual intercourse\n  4. NSAIDS within 72 hours of rectal sampling procedures\n* Continued need for, or use during the 90 days before enrollment, of the following medications:\n\n  1. Systemic immunomodulatory agents\n  2. Supraphysiologic doses of corticosteroids, except for short-course corticosteroids \\\u003C7 days duration at the discretion of the investigator. (Gender affirming hormone therapy is not exclusionary.)\n  3. Use of experimental medications, vaccines, or biologicals in the 12 months before enrollment",true,"MALE","18 Years",{"count":87,"type":88},200,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","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.\n\nThe study team will investigate whether the drug has additional effects on inflammation or on the bacteria that live in the body.",[94],"Sexually Transmitted Infections (STI)",[96,97,98,99,100],"Doxycycline post-exposure prophylaxis (doxy-PEP)","Gut inflammation","Prevention","PEP","STI","2026-04-26",{"date":103,"type":104},"2026-04-30","ACTUAL",{"date":106,"type":104},"2025-10-13",{"date":108,"type":88},"2029-04-13",{"name":5,"class":6},2]