Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens
- Registration Number
- NCT04860505
- Lead Sponsor
- Emory University
- 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 clinical trial of up to 20 men who have sex with men (MSM) and women aged 18-59, with measurement of anti-retroviral drug and doxycycline concentrations in the rectum and vaginal regions.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
-
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
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Not pregnant and no plans on getting pregnant throughout the duration of the study
-
Known allergic reaction to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Doxycycline and Biktarvy Biktarvy Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose. Doxycycline and Biktarvy Doxycycline Participants will take both study drugs simultaneously at home approximately 1 hour before Visit 2 and will be instructed to take a timestamped photograph or videotape of themselves taking the dose.
- Primary Outcome Measures
Name Time Method Plasma Doxycycline Concentration 24 hours after a single dose Doxycycline concentration in plasma was measured.
Vaginal Doxycycline Concentration 24 hours after a single dose Doxycycline concentration in tissue from a vaginal biopsy was measured.
Rectal Doxycycline Concentration 24 hours after a single dose Doxycycline concentration in tissue from a rectal biopsy was measured. Rectal biopsies were obtained from men. Women had the option to provide a rectal tissue sample.
- Secondary Outcome Measures
Name Time Method Vaginal Bictegravir Concentration 24 hours after a single dose Bictegravir concentration in tissue from a vaginal biopsy was measured.
Rectal Bictegravir Concentration 24 hours after a single dose Bectegravir concentration in tissue from a rectal biopsy was measured.
Trial Locations
- Locations (1)
Hope Clinic
🇺🇸Atlanta, Georgia, United States