Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Condition: Sexually Transmitted Diseases
MeSH terms: Sexually Transmitted Diseases
Intervention: Doxycycline; Biktarvy
Intervention description: Doxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.; Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Post-Exposure Prophylaxis; HIV; STI; PEP; Prevention

Summary:

      The study will determine tissue pharmacology of a single dose of doxycycline for sexually
      transmitted infection (STI) Post-exposure Prophylaxis (PEP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. HIV negative person, who was assigned male or female at birth, who reports sex with
             another man in the last year and is in good general health

          2. Aged 18-59 years

          3. Not currently taking PrEP and no plans to initiate during study

          4. Not currently taking PEP

          5. Not currently taking doxycycline or other tetracycline-derived antibiotics and no
             plans to initiate during the study

          6. Willing to use condoms consistently for the duration of the study

          7. Able to provide informed consent in English

          8. No plans for relocation in the next 4 months

          9. Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection,
             and a rectal or vaginal and cervical biopsy procedure

         10. Willing to use study products as directed

         11. Hepatitis B surface antigen (HBsAg) negative (screening lab test)

         12. Creatinine clearance >60 ml/min

        Exclusion Criteria:

          1. Currently infected with hepatitis virus and/ or has liver disease

          2. Current or chronic history of kidney disease or creatinine clearance (CrCl)<60 ml/min

          3. Continued need for, or use during the 90 days prior to enrollment, of the following
             medications:

               1. Systemic immunomodulatory agents

               2. Supraphysiologic doses of steroids (short course steroids less than 7 days
                  duration, allowable at the discretion of the investigators)

               3. Chemotherapy or radiation for treatment of malignancy

               4. Experimental medications, vaccines, or biologicals

          4. Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during
             the study, outside of the study procedures

          5. Intent to use doxycycline or other tetracycline-derived antibiotics during the course
             of the study, outside of the study procedures

          6. Any other clinical condition or prior therapy that, in the opinion of the
             investigator, would make the patient unsuitable for the study or unable to comply with
             the study requirements

          7. Not pregnant and no plans on getting pregnant throughout the duration of the study

          8. Known allergic reaction to study drugs