Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

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

Detailed Description
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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.

Official Title
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Combo-PEP: Multipurpose Prevention of Post-Exposure Prophylaxis Regimens

Conditions
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Sexually Transmitted Diseases

Intervention / Treatment
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* Drug: Doxycycline
* Drug: Biktarvy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Doxycycline and Biktarvy<br>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. | Drug: Doxycycline<br>* 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.<br>Drug: Biktarvy<br>* Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal Doxycycline Concentration | 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. | 24 hours after a single dose | 
| Vaginal Doxycycline Concentration | Doxycycline concentration in tissue from a vaginal biopsy was measured. | 24 hours after a single dose | 
| Plasma Doxycycline Concentration | Doxycycline concentration in plasma was measured. | 24 hours after a single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rectal Bictegravir Concentration | Bectegravir concentration in tissue from a rectal biopsy was measured. | 24 hours after a single dose | 
| Vaginal Bictegravir Concentration | Bictegravir concentration in tissue from a vaginal biopsy was measured. | 24 hours after a single dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Exposure Prophylaxis, HIV, STI, PEP, Prevention