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

Emory University20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Sexually Transmitted Diseases

Interventions

DoxycyclineDRUG

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.

BiktarvyDRUG

Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hope Clinic

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.