Status:
COMPLETED
Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
Lead Sponsor:
Emory University
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Sexually Transmitted Diseases
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
The study will determine tissue pharmacology of a single dose of doxycycline for sexually transmitted infection (STI) Post-exposure Prophylaxis (PEP).
Detailed Description
To determine tissue pharmacology of a single dose of doxycycline for STI PEP, investigators at Emory University will collaborate with the Centers for Disease Control and Prevention (CDC) to conduct a ...
Eligibility Criteria
Inclusion
- 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
- Aged 18-59 years
- Not currently taking PrEP and no plans to initiate during study
- Not currently taking PEP
- Not currently taking doxycycline or other tetracycline-derived antibiotics and no plans to initiate during the study
- Willing to use condoms consistently for the duration of the study
- Able to provide informed consent in English
- No plans for relocation in the next 4 months
- Willing to undergo peripheral blood, urine, rectal or vaginal secretion collection, and a rectal or vaginal and cervical biopsy procedure
- Willing to use study products as directed
- Hepatitis B surface antigen (HBsAg) negative (screening lab test)
- Creatinine clearance \>60 ml/min
Exclusion
- Currently infected with hepatitis virus and/ or has liver disease
- Current or chronic history of kidney disease or creatinine clearance (CrCl)\<60 ml/min
- Continued need for, or use during the 90 days prior to enrollment, of the following medications:
- Systemic immunomodulatory agents
- Supraphysiologic doses of steroids (short course steroids less than 7 days duration, allowable at the discretion of the investigators)
- Chemotherapy or radiation for treatment of malignancy
- Experimental medications, vaccines, or biologicals
- Intent to use HIV antiretroviral pre/post-exposure prophylaxis (PrEP or PEP) during the study, outside of the study procedures
- Intent to use doxycycline or other tetracycline-derived antibiotics during the course of the study, outside of the study procedures
- 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
- Not pregnant and no plans on getting pregnant throughout the duration of the study
- Known allergic reaction to study drugs
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04860505
Start Date
May 20 2021
End Date
May 9 2022
Last Update
May 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hope Clinic
Atlanta, Georgia, United States, 30322